Process Optimization

Reducing the Risk of Pharmaceutical Non-Compliance with Technology
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How Technology is Solving Pharmaceutical Compliance Risks in 2025
How Technology is Solving Pharmaceutical Compliance Risks in 2025 700 500 Xcelpros Team

At a Glance

The pharmaceutical compliance environment is more complex and unforgiving than it was even three years ago. From FDA warning letters to EMA’s evolving pharmaceutical regulatory compliance standards, the pharmaceutical industry is navigating a compliance environment that’s more complex and unforgiving than it was even three years ago.

For companies operating globally, compliance is no longer just a quality function. It’s a cross-departmental mandate that impacts profitability, time-to-market, and brand trust.

The good news? Advances in integrated ERP–MES platforms, electronic batch records, AI-driven labeling, and real-time analytics are enabling pharmaceutical manufacturers to identify and address pharmaceutical compliance risks before they escalate into costly non-compliance events.

Why Pharmaceutical Compliance Issues Still Happen and How It’s Changing

Despite investments, compliance issues in the pharmaceutical industry remain a challenge for three main reasons:

  1. Fragmented systems: Quality, production, and compliance teams often operate in silos, slowing risk detection.
  2. Process variability: Different sites follow different SOP interpretations, leading to inconsistent quality outcomes.
  3. Manual interventions: Even in automated environments, last-minute label changes or data entry can introduce errors.

The stakes are real. In 2024 alone, the FDA issued over 80% of warning letters citing poor documentation and data integrity, according to agency reports.

Where companies once relied on post-batch reviews, regulators now expect real-time oversight and the technology to prove it.

How Technology Closes the Compliance Gap

1. Integrated, Audit-Ready Recordkeeping

Modern compliance management systems don’t just store data, they connect every transaction, label change, and quality check across ERP, MES, and LIMS platforms.

Case in point:
A global generics manufacturer using an integrated electronic batch record system like iBR reduced document retrieval during inspections from hours to under 2 minutes, earning commendation for “data accessibility” in the FDA’s closing report.

2. Labeling That’s Always in Sync

In fast-moving markets, a label update delay can halt shipments and trigger compliance deviations. Integrated label management (like iCM) auto-pulls approved data from core processes, applies regional compliance rules, and generates ready-to-print labels without any manual re-keying.

Result: Zero label-related deviations in 12 months for one multi-site biopharma client, even while entering three new markets.

3. Standardized Processes Across Sites

Variability kills compliance. By standardizing SOP execution across all facilities via a single digital platform, companies ensure that role-based workflows are followed consistently, whether in a North American fill-finish line or an APAC packaging plant.

This isn’t theoretical:

  • A top-20 pharma reduced lot release delays by 27% after eliminating site-by-site SOP variations.
  • Every operator now follows the same digital prompts, with GenAI guidance for handling exceptions in real time.

4. Turning Data into Predictive Risk Intelligence

Compliance isn’t just about recording what happened, it’s about predicting what could go wrong. Modern analytics platforms flag anomalies as they occur: temperature drifts, out-of-spec readings, or deviations in operator behavior.

For example, one client’s system identified a series of small pH drifts during production, triggering a mid-batch adjustment that prevented a full-lot rejection, saving $2.4M in product value.

From Compliance Burden to Business Advantage

The conversation has shifted. In 2021, the focus was “how to avoid non-compliance.” In 2025, it’s “how to turn compliance into a competitive advantage.”

Risk readiness means:

  • Faster audits: complete, time-stamped records ready at a moment’s notice.
  • Lower cost of quality: fewer deviations, less scrap, reduced overtime.
  • Better ROI on tech investments: connecting MES, ERP, labeling, and QA delivers measurable business outcomes.

This is where XcelPros’ growing line of products like iBR, iCM, iQM, and other integrated MES solutions has repeatedly delivered quantifiable compliance wins for pharmaceutical leaders.

As regulatory bodies issue new pharmaceutical compliance updates, companies must adapt with agility to stay ahead of evolving expectations. Compliance will continue evolving. Regulators will expect more real-time transparency, more proactive risk management, and more integration between systems.

Companies that prepare now, aligning people, processes, and technology, will not only avoid costly deviations but accelerate market readiness and protect margins in an increasingly competitive landscape.

Key Takeaway

Compliance is no longer a defensive strategy. With the right technology, it becomes an enabler, safeguarding product quality, protecting revenue, and strengthening your position in the market.

Talk to us about building your risk-ready compliance strategy.

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Audit Readiness in Pharma: From Scrutiny to Systemic Strength
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Audit Readiness in Pharma: From Scrutiny to Systemic Strength
Audit Readiness in Pharma: From Scrutiny to Systemic Strength 950 658 Xcelpros Team

From Reactive to Proactive: Redefining Audit Readiness in Pharma

Audit readiness isn’t a checklist anymore. It’s not just about documentation or SOPs, or even about passing inspection.

Audit readiness is structural. It’s embedded into systems, habits, roles, workflows and culture. It’s no longer something teams prepare for, it’s something they live every day.

This shift has been driven by real pressures: accelerated drug approvals, cross-border manufacturing, evolving FDA expectations, and the sheer volume of digital data now involved in every batch, lot, and process decision.

Whether it’s a routine visit, a for-cause inspection, or a follow-up on previous 483s – the formal observation letters the FDA issues when it finds violations – audit readiness can’t be an afterthought, companies today need more than a binder of documents.

  • Full traceability at your fingertips
  • Real-time decision-making confidence
  • Zero disruption from inspection alerts

The days of scrambling are fading. The next era of audit readiness in pharma is being built on smarter systems, clearer context, and a much deeper integration between quality, operations, and compliance.

Why Audit Readiness in Pharma Still Struggles with FDA Audits

Most audit failures aren’t due to bad science, they’re due to fractured systems.

We’ve seen companies with robust SOPs and compliant lab data still end up with 483 observations because batch deviations weren’t linked back to inventory issues. Or because audit trails lived in too many disconnected systems, with quality and operations looking at different versions of the truth.

And while digitization has improved traceability, it’s also introduced new risks: inconsistent e-signature implementations, inaccessible metadata, or decentralized document controls that slow down rather than speed up response.

As Deloitte and Microsoft highlight in recent reports, the issue isn’t data scarcity, it’s data structure and systemic accountability.

The Evolution of Pharmaceutical Compliance Inspections

FDA audit types haven’t changed, but how companies prepare for them has.

  1. Pre-Approval Inspections (PAIs)

    Still high stakes. But the expectation is that your data flows – not just that it’s available. Inspectors now routinely ask for real-time batch status, in-process hold resolution data, or how corrective actions flow back into design controls. If your system can’t show that without stitching spreadsheets, you’re not ready.

  2. Routine QSIT Inspections

    Routine audits in the past meant “every few years.” Now, with increased risk scoring and cross-agency collaboration, we’ve seen some manufacturers get surprise follow-ups within 12 months. What’s under review isn’t just outcomes, it’s your ability to show the “why” behind quality decisions.

  3. Compliance Inspections

    These have gotten more rigorous. A 483 observation today isn’t just a citation; it triggers a close review of how systemic your fix really is. Did you patch a form, or did you fix the process? Was the CAPA just a response, or part of a broader improvement plan?

  4. For-Cause Inspections

    Triggered by recalls, complaints, or whistleblowers, these audits remain the most disruptive. But we’re seeing a trend: companies with clear audit logs, centralized risk registers, and linked deviation workflows are increasingly able to contain these inspections and avoid escalation.

The Role of Integrated Systems in Sustained Audit Readiness

Audit readiness has become an operational discipline, and enterprise systems play a central role.

At XcelPros, we’ve worked alongside quality and compliance teams in pharmaceutical environments that range from startup biotech to multi-facility manufacturers. What we’ve learned is this: the most audit-ready teams don’t rely on checklists. They rely on visibility.

That means real-time access to:

  • Batch genealogy from raw material intake to packaging
  • Deviation logs tied to CAPAs and preventive actions
  • Change controls embedded in training workflows and SOPs
  • E-signature validation built for 21 CFR Part 11 compliance

These aren’t features, they’re requirements for audit resilience.

Solutions like our iCM platform (Integrated Chemical Management), while designed initially for GHS labeling and DEA tracking, have evolved into audit-ready control towers for batch documentation, quality workflows, and regulatory traceability. When SDS, label logic, and compliance data live in one system, audit prep becomes an ongoing behavior, not a last-minute scramble.

Discover how integrated systems transform audit prep into daily readiness.

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What AI Means for Audit Readiness (and What It Doesn’t)

AI is reshaping compliance, but not by replacing people. This isn’t about AI replacing your quality lead or writing SOPs. It’s about AI helping your team spot issues earlier, assess risk faster, and generate audit narratives from structured data.

Here’s what is real:

  • Predictive AI that flags deviations is likely to result in 483s based on historical FDA data.
  • Agentic AI models trained to run mock audits, simulate document requests, and test data integrity workflows.
  • Industrial AI assistants that suggest responses to Form 483 observations based on similar past cases, but with audit trail transparency.
  • Generative tools that compile batch data and supporting documents for audit response packets in minutes, not hours.

But none of these matters if the data feeding the model is unreliable. Which is why integrated systems, like iCM, are critical. They provide the data foundation that makes AI usable, auditable, and trustworthy.

Final Thoughts: From Panic to Prepared

Audit readiness in pharma is no longer about “preparing for the worst.” It’s about designing for the expected, and that expectation is constant scrutiny.

The companies that succeed aren’t the ones with spotless track records. They’re the ones who can trace decisions, document actions, and correct courses in real time.

From digital systems to AI assistants, audit readiness is evolving into a reflexive behavior, not reactive scramble. That’s the future. Not compliance by crisis, but compliance by design.

Future-proof your audit readiness in pharma, Get a Compliance Readiness Assessment.

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GHS Compliance in 2025: From Reactive Reporting to Integrated Readiness
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GHS Compliance in 2025: From Reactive Reporting to Integrated Readiness
GHS Compliance in 2025: From Reactive Reporting to Integrated Readiness 950 627 Xcelpros Team

Introduction

For chemical manufacturers, compliance is not a checkpoint. It’s a daily operational reality. And in 2025, managing GHS chemical labeling compliance isn’t just about printing the right pictograms or storing SDS files. It’s about making sure your data, documents, and decisions are aligned across systems, stakeholders, and time zones. It’s about safeguarding your brand, your supply chain, and your license to operate in a fragmented global market.

The rules haven’t become simpler. They’ve become faster. Regulatory expectations now assume companies have integrated visibility, not just paperwork. And with AI playing a more active role in industrial compliance, the assumptions around what’s “reasonable to expect” from a chemical company are shifting, pushing towards greater proactive readiness.

So, what does that mean for labeling, SDS, and compliance today?

The Realities Compliance Teams Still Navigate

Despite years of digital transformation, many chemical firms still struggle with:

  • Label duplication and inconsistency

    Teams manually adjust label templates based on product or geography, introducing inconsistency and delay. Imagine the headache of a single product requiring five slightly different labels for five key export markets, a small error here can mean costly recalls or delayed shipments.

  • SDS authoring silos

    Authoring, translation, and version control often exist in separate systems (or spreadsheets), increasing compliance risk, particularly with the need for rapid updates due to new classifications. This often feels like a never-ending game of whack-a-mole, where an update in one country triggers a cascade of manual changes that are difficult to track.

  • Delayed regulatory responses

    By the time a new DEA rule or GHS update makes it into a workflow, batches have already been produced, shipped, or flagged. This is particularly challenging given the accelerated pace of global regulatory changes in 2025. The cost isn’t just fines; it’s lost market opportunities, reputational damage from product seizures, and the sheer inefficiency of rework.

These aren’t edge cases. They’re the lived experience of mid-sized chemical companies working across geographies and product lines, companies with growing volumes, growing regulation, and limited margin for rework.

What’s Changed in 2025?

GHS compliance is now deeply tied to the operational structure of your business. The days of bolt-on compliance tools are fading. Regulators are looking not only for the presence of data but for evidence that it drives behavior.

The year 2025 marks a period of significant GHS evolution and implementation worldwide, necessitating a shift from reactive reporting to integrated readiness:

  • Global Harmonization, Local Variations – A Geopolitical Dance: While the goal is harmonization, regional adoptions of different GHS revisions create complexity, often reflecting diverse national priorities, trade bloc regulations, or socio-economic considerations. For instance:
  • Brazil mandates the implementation of ABNT NBR 14725:2023 (based on UN GHS Rev. 7) by July 4, 2025, introducing new categories and classification adjustments. This update underscores South America’s increasing integration into global chemical trade, demanding specific compliance pathways for companies exporting to or manufacturing within this growing market.
  • The European Union is preparing to align its CLP Regulation with GHS Revisions 8-10, and partially with Rev. 11 (aerosols, skin sensitizers in mixtures), with delegated regulations expected by late 2025 and a likely two-year implementation period. The REACH Recast, also expected by late 2025, will bring significant changes, including expanded hazard classes (e.g., endocrine disruptors, PMT substances). The EU, a major importer and exporter, continues to set a high bar for chemical safety, influencing global standards and requiring meticulous adaptation from its trading partners.
  • China is seeing new mandatory national standards, such as GB 45673-2025 for hazardous chemical enterprises (effective November 1, 2025) and GB 6944-2025 for dangerous goods classification (effective October 1, 2025), which refine classification rules and expand scope. As a global manufacturing hub and a critical market, China’s evolving GHS alignment presents unique challenges and opportunities, requiring careful navigation of its specific regulatory frameworks.
  • Japan’s JIS Z7252:2019 and JIS Z7253:2019 (based on UN GHS Rev. 6) are expected to be revised in 2025 (or early 2026) to align with UN GHS Rev. 9, impacting flammable gases, pressurized chemicals, and hazard/precautionary statements. Japan’s precise regulatory landscape often influences Asian regional practices, making its updates critical for companies with a presence across the continent.
  • The United States (OSHA HCS) completed its alignment with GHS Rev. 7 as of July 19, 2024, bringing stricter SDS content/format, a critical 90-day update timeline for new information, and enhanced labeling requirements (including QR codes). The US, with its vast internal market and trade relationships, mandates that companies align with its specific HCS amendments, creating another distinct compliance pathway.

What’s new:

  • Version-aware SDS workflows: It’s not just about having the latest sheet, it’s about ensuring the right sheet version reached the operator or customer at the right time, especially with continuous updates from various GHS revisions and the imperative to comply with the most current regional standard.
  • Label printing logic tied to production steps: Regulatory label changes are being tied directly to batch triggers—what gets printed when, and how it varies by geography or use-case, including bilingual requirements (as seen in India’s Insecticides Rules 2025) and the integration of new pictograms or hazard statements from GHS Rev. 11.
  • DEA compliance tracking is tightening: Reporting expectations are stricter across Schedule II chemicals. Time lags and manual reconciliations are being scrutinized. This tightening reflects global efforts to combat illicit drug diversion, impacting chemical supply chains worldwide.

This is where integrated systems start making the difference – not by doing more, but by making the compliance layer the natural byproduct of production, not a separate task to remember. It transforms compliance from a cost center into a strategic enabler for seamless global operations.

Where AI Is Starting to Matter

AI is no longer a novelty in chemical manufacturing; it’s a real tool. But in compliance, how it’s used — and how leading organizations adopt it — makes all the difference.

In 2025, we’re seeing three dominant AI capabilities emerge alongside proven industry practices:

  1. Predictive AI

    AI models now flag labeling issues before they happen based on past violations, region-specific rules, or unusual material usage patterns. This means compliance risks can be anticipated across diverse markets. For example, an AI engine can highlight a potential non-compliance issue for a shipment bound for Brazil before it leaves the factory floor, saving immense time and cost.

  2. Agentic AI

    Semi-autonomous agents assist with exception handling, template configuration, and even SDS language suggestions based on the latest rulebooks like GHS Rev. 10 or Rev. 11. Imagine an AI assistant autonomously proposing the correct precautionary statements for a new hazardous substance classification based on EU CLP updates — then routing it to compliance officers for review.

  3. Industrial AI with Built-in Regulatory Intelligence

    The new frontier is models that self-train on compliance libraries (GHS, OSHA, WHMIS, DEA, etc.) and adapt dynamically as regulations change. Instead of manually feeding in updates, these AIs learn the nuances of evolving standards — whether Chinese GB updates or Indian CMSR drafts — and reduce the burden on human compliance teams.

How Industry Leaders Are Approaching GHS Compliance

While AI is enabling compliance, global leaders are pairing technology with rigorous governance:

  • Supply Chain Rigor: Companies like Apple, Google, and Microsoft enforce strict Restricted Substances Lists (RSLs) and supplier codes of conduct. They mandate GHS-compliant SDS, labeling, and worker training throughout their supply chains — even in regions where enforcement lags. Proactive auditing of supplier chemical management reduces global risk exposure.
  • Internal Operations & Product Stewardship: Within their own operations, these companies embed GHS into Environmental Health & Safety (EHS) frameworks, covering chemical storage, handling, and waste. Amazon, for example, requires sellers to provide GHS-compliant SDS and labeling for listed products — extending compliance to its vast ecosystem.
  • Leveraging Technology: These same tech giants use digital platforms and analytics to track chemical use, manage SDS libraries, and enforce compliance at scale. This aligns closely with the integrated readiness that AI platforms like iCM support.
  • Strategic Advisory & Transformation: The Big 4 consultancies (Deloitte, PwC, EY, KPMG), along with firms like Accenture and McKinsey, are helping chemical manufacturers translate GHS into enterprise strategies. Their work spans compliance roadmaps, integrated EHS platforms, AI-driven SDS authoring, risk gap assessments, and training — embedding GHS into broader ESG strategies.

The Takeaway

AI is only as good as the infrastructure underneath it. Solutions like iCM are enablers — unifying labeling templates, SDS logic, regulatory mappings, and audit histories so AI has structured, trusted data to work with.

At the same time, the way industry leaders approach compliance — combining rigorous supply chain standards, operational EHS discipline, technology adoption, and advisory expertise — offers a blueprint. Together, these trends show that GHS compliance in 2025 is less about reacting to regulations and more about building proactive, resilient systems that integrate AI, governance, and global best practices.

Discover how AI-powered compliance reduces risk.

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What iCM Represents

We built iCM not as a response to market buzz, but in direct collaboration with teams who live these problems daily. DEA reporting inconsistencies. Multi-region SDS formatting. GHS label updates that miss a country-specific nuance and trigger rework.

iCM brings SDS, DEA, and GHS into a single environment. But that’s not the pitch, it’s the baseline.

What it means practically is:

  • Fewer touchpoints for error.
  • Real-time synchronization between regulatory updates and operational templates.
  • Faster reaction when rules change, because the system changes with them.

And perhaps most importantly, a space where compliance data doesn’t just sit idle, it drives decisions.

What’s Ahead: Compliance as a Workflow, Not a Checkpoint

In the next 12–24 months, chemical companies will face a compliance environment that is more fragmented, more digital, and more unforgiving:

Region-Specific Variance Will Accelerate

With GHS Rev. 10/11 rolling out, EU CLP 2023–2024 amendments taking effect, and India’s CMSR draft nearing enforcement, global exporters will contend with sharper regional differences. Leaders are already adopting supplier codes of conduct and RSL frameworks that assume compliance everywhere, not just where enforcement is strict.

AI Validation Loops Become Standard Practice

Compliance teams won’t just use AI for SDS authoring or label checks, they’ll actively validate and retrain it against constantly updating regulatory libraries. This closes the gap between fast-moving revisions and the slow pace of human-only reviews, reducing both risk and rework.

Real-Time Compliance Reporting as a Mandate

From DEA precursor tracking to SDS distribution logs, regulators are shortening compliance reporting windows. SDS updates within 90 days (US), instant hazard communication requirements in EU, and traceability expectations in Asia all point toward a world where “near real time” is the new baseline.

Compliance as an Operational Advantage

Organizations that treat compliance as part of supply chain resilience and ESG strategies, not just audit prep, will be the big winners. This means aligning compliance workflows with supplier management, product stewardship, and digital EHS platforms. As Apple, Microsoft, and Amazon demonstrate, proactive rigor sets the bar higher than regulations demand, ensuring operational continuity and brand protection.

The companies that wait for their annual audit, or for a violation to trigger investment, will be left scrambling. The companies that integrate compliance into daily operations, as a workflow, not a checkpoint, will define the new standard.

Unify SDS, DEA, and labeling into one system.

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Final Thoughts: Future-Proofing Chemical Compliance

GHS chemical labeling compliance in 2025 is not just a checkbox, it’s a living, adapting system of people, data, and automation.

Yes, the penalties still matter. Yes, the rules are still complex. But the bigger story is how compliance is evolving into a driver of operational intelligence and supply chain resilience. Industry leaders are proving that compliance isn’t just internal, it extends across global supplier networks, EHS frameworks, and ESG strategies.

You don’t need five tools or a battalion of consultants to keep up. What you need is the right architecture: a foundation that unifies labeling templates, SDS logic, regulatory mappings, and audit histories. That’s what allows AI to add real value and ensures supplier compliance is aligned with global standards whether it’s GHS Rev. 11, EU CLP updates, or emerging regional frameworks like CMSR in India.

Because in chemical manufacturing, compliance is not just about being correct. It’s about being ready. Ready for audits, ready for shifting rules, and ready to operate with the same rigor and foresight as the world’s most resilient enterprises.

Warehouse management challenges in the pharmaceutical industry banner
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Warehouse Management Challenges in the Pharmaceutical Industry
Warehouse Management Challenges in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

The pharmaceutical industry faces some unique warehouse management challenges. Many of these issues can dramatically impact medications, even though they may not exist in industries such as general retail.

Key issues facing warehouse managers include:

  • Keeping portions of their facilities at the correct temperatures to prevent medications from spoiling.
  • Following federally-mandating good manufacturing process rules.
  • Security issues for products and intellectual property.
  • Inventory controls.

Warehouse issues specific to the pharmaceutical industry include:

  • Temperature control: Active pharmaceutical ingredients (APIs), precursor chemicals, and manufactured drugs frequently require controlled temperatures. A general temperature range for a cool, dry place is between 59-77° F (15-25° C). Some products, such as vaccines, may require freezing. Exposing drugs to the temperature outside their effective ranges can cause chemical changes and reduce a drug’s effectiveness. For example, Baystate Health states that medications containing hormones do not work as well when exposed to colder or hotter temperatures.
  • Humidity control: Moisture condensing inside packages can impact a medication’s effectiveness. Baystate Health states that blood glucose strips exposed to humidity will give inaccurate readings.
  • Light exposure: Exposure to ultraviolet light from the sun and other sources can change the chemical structure of some medications. The light exposure causes photodecomposition, reducing the medication’s potency. Light exposure can also cause side effects after administration, such as phototoxicity and photoallergy, a 1997 post in PubMed states.
  • Adhering to the Food and Drug Administration (FDA) Current Good Manufacturing Process (CGMP) standards for warehouses, processes, and drugs: Includes keeping careful track of item locations within the warehouse.

According to Kanban, the FDA’s CGMP warehouse standards include the following:

  • Contamination prevention: Storage must allow inspection and cleaning.
  • Identification: Each drug must have a unique, traceable code that identifies the lot’s status, such as approved, quarantined or rejected.
  • Distribution Procedures: Written procedures describing the distribution process for each drug including recalls.
  • Storage Procedures: Written procedures describing the storage conditions for each drug are required.

Some pharmaceuticals require only temperature controls for specific ranges. Other medications require climate-controlled environments affecting temperature and humidity.

Figure: 1Pharmaceutical Warehouse Management Challenges

Pharmaceutical Warehouse Management Challenges

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Following GMP Rules

GMP SOP states that following the Good Manufacturing Process (GMP) rules enables manufacturers to:

  • Protect medicines and raw materials for medicines during storage
  • Prevent finished product degradation
  • Avoid contamination from other materials
  • Prevent damaged or expired products from being shipped

Warehouse managers also face the challenge of keeping track of three types of items appearing on the packaging bill of materials governed by GMP procedures. Each of these item types requires unique lot numbers:

  • APIs, precursor chemicals and other starting materials
  • Packaging materials
  • Printed materials

All warehouse managers face inventory control requirements. Those in the pharmaceutical sector also deal with intense government scrutiny.

Receiving Shipments

Other GMPs in the pharmaceutical industry require materials arriving from suppliers to be reviewed based on their use. For example, it’s important to check starting chemicals to confirm they are:

  • From a source approved by the company
  • Free of damage and defects
  • Labeled with all required information
  • Have a unique identifier
  • Registered in the company’s inventory database
  • Quarantined until quality control tests are performed
  • Stored appropriately and safely, such as in a temperature-controlled section or “Dangerous Goods” area for flammable and toxic materials

Unlike retail goods warehouses, pharmaceutical warehouse managers should also set aside an area for raw materials to be tested and confirmed to meet all required standards. A similar section should exist for any materials that fail these tests, GMPSOP states.

Sampling and Testing

Sampling and testing should be done in a room having sections with positive air pressure (i.e., the air pressure is higher than that outside, preventing contaminants such as dust, microbes, pollen, cleaning agents and lubricants from entering) and negative air pressure (i.e., the pressure is lower than that outside to prevent materials from inside the room going outside). An airlock with positive pressure keeps out external contaminants. With the airlock sealed, the inner testing can have negative air pressure to keep chemicals from contaminating the larger warehouse.

Other sampling room requirements include clean instruments and appropriate personal protective equipment (PPE) as required by the federal Occupational Health and Safety Act (OSHA) and the FDA. OSHA has a downloadable brochure on warehouse safety.

Storage and Tracking Inside the Warehouse

“Lack of control over material movement in the warehouse can, and has, led to defective products,” GMPSOP states.

General warehouse practices (GWP) require that:

  • Received unused goods and finished products are quarantined until approved for release.
  • Items have correct status labels (e.g., current, expired, etc.)
  • Unique identifiers are visible.
  • Products are stored by type when appropriate.
  • Access to toxins and addictive drugs or chemicals is stored separately. Access is limited only to approved personnel.
  • Materials are tracked as they move through the production facility from the Receiving area to Production and then to the Shipping.

When possible, warehouse managers should have separate sections to store damaged or returned goods, recalled items, “not for sale” samples and when identified, counterfeit materials.

Labeling

Another challenge for pharmaceutical warehouse managers is accurate labeling. GMP rules require labels to include a familiar name and Unique Identification Number that must be different from the supplier’s lot number. The UIN must be recorded in the lab, on the facility’s computer system, and in production. GMP SOP suggests not referring to the IUN as a batch number.

Other requirements unique to pharmaceutical labeling include:

  • Expiration dates
  • Barcodes for additional tracking options
  • Status indications, typically in the form of a color code
  • Quarantined products
  • Items being held for investigation
  • Rejection labels when an item fails to meet required standards
  • Approval and/or release labels indicating the item can proceed to the next step in the supply chain

Security Challenges

Medicines and other pharmaceutical products are in high demand, making them tempting targets.

Warehouses should have secure physical storage areas for raw materials and finished products.

In addition, Avcostar states that the formulary, drugs, and drug components are expensive and prone to theft. It suggests performing a risk analysis audit that includes where known security breaches occurred. “The company can then focus on identifying and eliminating the most vulnerable posts and systems against malicious access, modification or deletion of data, enhance access control to systems and data and implement new cybersecurity best practices,” Arecont Vision Costar VP of Marketing Jeff Whitney states.

The code of federal regulars 21 CFR Chapter 1 requires control of all production stages, including system validation and audit trails. Refer to this article from Cornell Law School for detailed information.

Solving Challenges

Effective use of warehouse management computer systems, such as the warehouse management module in Microsoft Dynamics 365’s Supply Chain Management, can help track inventory management in pharmaceuticals accurately and manage these challenges.

The module “has a wide range of features to support the warehouse facility at an optimal level at any time,” according to Microsoft. Among the warehouse module’s functions are:

  • Workflow support
  • Using mobile devices
  • Full batch and serial item support
  • Label printing and routing
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The Importance of Pharmacovigilance During a Pandemic
The Importance of Pharmacovigilance During a Pandemic 700 500 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient.
  • Continuously collating and monitoring a particular drug’s safety data.
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug.
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels.
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies.

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess the safety profile of every drug.

This task requires constant alertness and unprecedented agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. Combining finely tuned digital tools and well-trained employees is the best way to protect patients from severe injury or death.

A drug maker’s automated quality control program should be smart enough to help collect, analyze and check data. The software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

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To comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process of end-to-end pharmacovigilance.

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, nutritional supplements and dietary products
  • Formulating a plan for intervention, mitigation, assessment and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach toward pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

References: Pharmacovigilance: Regulation and Prequalification

How a pharma CDMO can manage the serialization challenge banner
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How a Pharma CDMO can manage the Serialization Challenge
How a Pharma CDMO can manage the Serialization Challenge 700 500 Xcelpros Team

At a Glance

  • Today, serialization has moved from being a luxury option to a necessity.
  • Pharmaceutical companies are hiring contract development and manufacturing organizations (CDMOs) to develop solutions that maintain drug quality while avoiding supply chain problems.
  • Pharmaceutical serialization lets manufacturers keep accurate track of their inventory wherever it may be.

As more pharmaceutical and chemical companies move to digitize their operations, they’re looking for ways to track raw materials and finished products through the manufacturing cycle. One way to track these products is through serialization.

“Serialization is the assigning of a predetermined coding type to each product item, assigning it a distinct identity” for tracking and tracing its location in the supply chain,” RFXcel.com states. A simple definition calls serialization, “the process of assigning a unique identity to each saleable product item,” according to Neurotags.com.

Pharmaceutical companies that have gone digital are starting to use serialization to track and trace their products throughout the supply chain. The industry is constantly looking to improve its tracking systems to combat counterfeiting, theft, packaging and storage errors. Companies are also worried about their products being altered after leaving their plants.

Pharmaceutical companies often hire contract development and manufacturing organizations (CDMOs). Using digital labeling methods such as barcodes and QR codes (a type of barcode) helps serialize the supply chain, making tracking raw materials and finished goods easier.

30-40% of all medicines circulated in the developing countries are counterfeit.
5-7% of all medicines circulated in the developed countries are fake. Source: WHO Report

Counterfeit drugs pose a serious threat to the public’s health. They also damage the reputations of legitimate companies and the pharmaceutical industry globally.

CDMOs worldwide face challenges when implementing a robust pharma serialization solution. Streamlining manufacturing and distribution processes while understanding their client’s unique requirements is challenging.

Serialization Challenges Faced by CDMO

Some of the challenges a CDMO faces while implementing pharmaceutical serialization for track and trace functionality include:

Seamless Serialization for Multiple Clients

CDMOs typically prefer to operate globally, providing comprehensive drug manufacturing and supply services to many pharmaceutical companies. Catering to a diverse client base has its unique set of challenges, especially when it comes to the serialization of individual drugs.

CDMOs need to equip themselves with the right technology to be able to modify their production or manufacturing lines and seamlessly label multiple drugs for different clients.

Regional Compliance

Every country around the world can have different regulations for exporting drugs. Labeling—or serialization—is part of that compliance. CDMOs are expected to take responsibility in terms of drug quality of drugs and compliance with various government rules. Being in compliance is challenging for CDMOs, especially considering the volume of information required to achieve it.

Figure: 1Key Serialization Challenges Faced by CDMOs

Key Serialization Challenges Faced by CDMOs

Picking the Right Labelling Solution

When it comes to drug serialization, a “one size fits all” approach to labeling solutions doesn’t always work. Assuming a CDMO has a preferred labeling software, there’s still the important decision of choosing:

  • Printer types such as thermal inkjet, thermal transfer, lasers
  • Printing materials such as paper, film or holograms
  • Special formulas to make counterfeiting harder

In terms of label design, everything must meet government codes and regulations. This applies to label layout, orientation, barcode configuration and other design elements. Every label must be printed in time to avoid delaying shipments. CDMOs are pressured to make the right choices for coding and labeling products.

Understanding Market Requirements

While larger pharmaceutical manufacturing companies use an in-house team of analysts and marketing specialists, smaller firms often rely on CDMOs for market intelligence.

When it comes to labelling client drugs, CDMOs need to understand the different markets and their requirements. Using market analysis, CDMOs must decide how many drugs need to be labelled for a particular market, including whether they’re choosing to label randomly or with a centralized approach.

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Overcoming Serialization Challenges

No two CDMO clients are the same and neither are the challenges each CDMO faces. In terms of how each company deals with its serialization issues, they should consider:

  • Equipping their workforce with the technical knowledge and details of serialization hardware and software
  • Making use of advanced technological applications like Big Data, cloud computing, the Internet of Things (IoT and advanced analytics)
  • Understanding how enterprise resource planning (ERP) software, like the Microsoft Dynamics 365 line of modular product, can help them maintain and monitor client data

With the right software and people skilled in its use, a CDMO can manage multiple production lines while meeting drug production requirements for different clients.

Investing in the right partner with experts that understand global pharmaceutical regulations will help CDMOs label and locate their products no matter where they are in the world.

Since CDMOs are not only vendors but also producers, they need to be in constant contact with their clients and suppliers. This includes dealers, wholesalers, packagers and transporters. Using the right ERP will help them maintain transparency at every level while avoiding recalls or stock-outs.

CDMOs benefit by developing flexible templates for their serialization solutions. These templates serve as a blueprint for any pharmaceutical client. Making them flexible lets a CDMO adjust a process to meet the client’s requirements, saving time, effort and money.

Final Thoughts

Drug serialization and labelling pose several challenges for CDMOs around the world. However, managing these challenges is an excellent opportunity for an organization to show its technological skills. When a CDMO has the right team and solution, it can overcome any challenge.

Taking advantage of products like Microsoft’s Dynamics 365 suite of solutions gives pharmaceutical companies access to powerful tools. Included is a way to track serialization, such as customer onboarding and lot traceability to toll manufacturing, from start to finish.

Using a powerful and effective ERP to enhance serialization will help a CDMO combat counterfeiting and theft while ensuring government compliance. At the same time, good software can also help a CDMO establish a more efficient supply chain.

Meeting serialization requirements for pharmaceuticals pose many technical and skill-based challenges. CDMOs worldwide are constantly looking for more efficient ways to handle these challenges. Investing in the right partner can make a big difference.

With the help of cutting-edge applications, a skilled team and a systematic approach toward serialization, CDMOs can establish themselves as leading end-to-end manufacturing and distribution partners.

References: What Is a CDMO (and Why Do You Need One)

supply chain disruption management
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How to Manage Operations During Supply Chain Disruptions
How to Manage Operations During Supply Chain Disruptions 700 500 Xcelpros Team

Introduction

Even today, Covid-19 continues to disrupt every level in supply chains, across every industry around the world. The lasting effects on supply chains was unanticipated, especially concerning food and cleaning supplies. Manufacturers in those areas had an unexpected spike in demand that couldn’t be managed quickly.

The overall supply chain disruption caused many companies to start re-evaluating action plans. Areas being closely examined today include production capacity, cash flow and overall employee morale.

Let’s look at how businesses can leverage existing practices while pivoting to newer methods and meeting evolving customer needs.

Figure: 1Surviving the Supply Chain with a Digital and Analytical Backbone

Surviving the Supply Chain with a Digital and Analytical Backbone

Communication and Collaboration

The first quarter of 2020 brought new dynamics to manufacturers and distributors everywhere, faced with a challenge the likes of which have never been seen before. As market dynamics changed, internal communication became critical at every stakeholder level: management, employees, customers, suppliers and vendors. Creating a communication strategy that could work when people stopped meeting face to face became vital to avoid business breakdowns and shutdowns.

That was 2020. The lingering effects of Covid-19 are still impacting some companies’ technology roadmap plans. However, there are ways to drive innovation and growth. Regardless of industry, many organizations realize the importance of doing business from anywhere. That flexibility to work on the move is no longer a luxury: it is a necessity. Unconventional work schedules are becoming more common as companies adjust to meet customer expectations. Companies are engaging them with messaging and video call software such as Microsoft Teams. They use software such as Power Automate to deploy safety alert messages whenever the need arises.

Customer and vendor portals equipped with Microsoft Dynamics 365 Supply Chain Management let companies collaborate, determine product access and make accurate forecasts without having to pick up the phone. Instead of days or weeks of delays, modern software helps firms resolve supply chain disruptions at a moment’s notice.

Manufacturers using Microsoft Dynamics 365 Supply Chain Management can integrate Internet of Things (IoT)-enabled devices and robots into their current operations. Using machine learning adds even more automation.

Connecting data and processes with Microsoft’s wide selection of products allows production and maintenance teams to schedule downtime when it has the least impact on production. Outlook messages and alerts let production staff stay on top of any possible repair issues.

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Agile decision making

Manufacturers must respond to the rapid changes in customer demands and delivery expectations. Having a robust system lets that happen.

Changes to your customers’ business demands can affect your supply chain. Having the ability to act quickly while still providing exceptional customer service is critical to future business success.

One way to prepare for these changes is by having internal cross-functional teams practice scenario planning. For example, they can plan what to do if a new Covid-19 variant appears and governments reinstate drastic safety measures.

Scenario planning lets your staff learn what to do when normal deliveries are delayed or rerouted, such as what happened when the Suez Canal was blocked for a week. It lets your staff examine past customer and supplier behaviors and come up with plans to minimize disruptions using what they learned.

Microsoft Dynamics 365 Supply Chain Management includes tools designed specifically for scenario planning. It helps companies adjust to unexpected changes in their supply chains. These tools include:

  • Drag and drop Gantt charts for production scheduling
  • 360 degree view into capacity, identifying bottlenecks in terms of people and resources
  • Adjusting safety stock to reflect real-time demands instead of fixed quantities
  • A vendor portal with approved suppliers listed in a supplier resource management database that includes purchase order controls
  • Visibility into warehouse operations for single and multi-site facilities
  • Transportation management
  • A customer portal with sales order management

Incorporating Data

Data in today’s operations is a moving target. Making decisions and providing insights with real-time information helps companies operate efficiently, letting them grow and scale at the right times. Identifying organizational segments that require optimizing, like the handoffs between operations and finance, can only occur when accurate information is available.

For example, the only way to truly analyze cash flow—to get a 360-degree view—is by looking at data within each division.

This is where a business analysis tool like Power BI becomes an essential part of the process. Power BI dashboards using predictive analytics in the Dynamics 365 environment automatically update with the latest data. These dashboards let companies monitor the status of multiple locations at once, saving time.

Tools such as Power BI let management share data, communicate and respond to changes in the market within minutes, not days.

Final thoughts

The coronavirus is the first disruption of its kind faced by this generation. Companies were caught unprepared, being forced to adjust almost instantly to upheavals in their supply chains. Having the right tools in place to deal with Reduced workforces internally and within the supply chain, pivoting production to new products and unprecedented customer product demand helps determine who flourishes and who fails.

With that in mind, it’s critical to consider implementing products from Microsoft’s family of partner solutions. Dynamics 365 and related products help companies predict and manage their operations transparently.

References: Why the Pandemic Has Disrupted Supply Chains (whitehouse.gov)

How Sustainable Operations Helps Manufacturers Grow
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How Sustainable Operations Helps Manufacturers Grow
How Sustainable Operations Helps Manufacturers Grow 700 500 Xcelpros Team

Introduction

Every business leader has heard the term “sustainable manufacturing,” but not all know that practicing methods that help the environment can also grow their business.

“Sustainable manufacturing is the creation of manufactured products through economically-sound processes that minimize negative environmental impacts while conserving energy and natural resources,” the United States Environmental Protection Agency states. These same practices enhance employee, community and product safety in part by producing less waste that pollutes the air, water and soil.

According to the EPA, companies that use a methodical, planned approach to sustainable manufacturing processes:

  • Increase operational efficiency by reducing costs and waste
  • Respond to or reach new customers and increase competitive advantage
  • Protect and strengthen brand and reputation and build public trust
  • Build long-term business viability and success
  • Respond to regulatory constraints and opportunities

Fostering Growth

These environmentally friendly sustainable manufacturing practices help companies grow by reducing production costs long term. For example, instead of paying thousands of dollars each month to an electric company to light and cool a 300,000 square-foot manufacturing plant, consider covering a flat roof with efficient solar panels.

The average payback time for a home solar electric installation (industrial estimates were not available) is roughly 6-10 years, though it varies depending on the climate and other factors. Solar panels also tend to last 25-40 years meaning roughly three-quarters of their useful lives is spent generating free electricity. The most recent designs are much more efficient, producing more power in a smaller size, than those made 10 years ago. The result is greater efficiency, allowing manufacturing facilities to cover less of their roofs while producing as much or more power than the older models.

Production plants can also reduce their massive electrical bills with skylights. The waterproof domed coverings help illuminate work areas, reducing the need of electric lighting. Extended exterior shelves can reduce sunlight, cutting cooling costs.

Figure: 1 Sustainable Manufacturing – a Big Picture

Sustainable Manufacturing - a Big Picture

Turning Trash Into Treasure

Other sustainable methods look at ways to reduce waste, especially by converting some “trash” into new products or using it for new methods.

One website alone lists 35 artful ways homeowners can recycle wooden pallets. These new uses include making tables, bed frames, stairs, mounting frames for heavy electronic display monitors and a host of other uses. Many of these same methods work for industrial companies in terms of outfitting conference rooms and other non-work areas.

From an industrial perspective, worn pallets can be repaired, cleaned and reused. They can also be sold, recouping some of the cost. Other uses for worn pallets include chipping them, turning them into wood pellets. The pellets can then be burned, generating heat and electricity.

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Cascading Chemicals

Recycling is a large part of the sustainable “green” economy. Industrial chemicals can be recycled. They can also be reused through a process known as “industrial symbiosis,” greenbiz.com states. One example cited uses ferric chloride, which is a byproduct of steel pickling in hydrochloric acid, to treat water.

“Frequently, recycled chemicals are not only cheaper than newly produced ones, but they also reduce resource consumption, waste generation and greenhouse gas emissions. The carbon emissions through solvent recycling are 46 percent – 92 percent lower than those of new solvent production,” the website states.

When the article was written in 2019, industrial giants Siemens and Evonik were conducting research to convert the most common greenhouse gas—carbon dioxide (CO2)—into common industrial chemicals such as ethylene.

Other methods used to reduce chemical and industrial waste cited by greenbiz include swapping what might be one manufacturer’s trash with a different nearby business. That business can use these materials in its products.

Another environmentally friendly industrial method is “leasing” chemicals. In this model, a manufacturer sells the functions performed by the chemical using functional units, not the chemicals themselves.

Large manufacturers with their own wastewater treatment plants can redesign those facilities in ways that help the company turn a profit and grow. Companies interested in practicing sustainable manufacturing practices can modify existing equipment to produce energy, clean water and chemicals because, “the future of sewage is power and profits.”

The greenbiz.com article ends with a quote made in 1848 by the former president of the London Royal College of Chemistry, R.W. Hoffmann: “In an ideal chemical factory there is, strictly speaking, no waste but only products. The better a real factory makes use of its waste, the closer it gets to its ideal, the bigger is the profit.”

Technology Can Spot Opportunities

One way a company can practice sustainable operations management is by using its data wisely. Especially in forward-thinking firms that use internet of things (IoT)-enabled devices, they have access to mountains of information.

Combining a well-thought plan with the right software lets these firms look at everything coming into their warehouse—including packaging—as potential profit sources. Enterprise resource planning (ERP) products such as Microsoft Dynamics 365 and its Supply Chain Management Module let companies of any size keep accurate track of their inventories. Add in the Integrated Chemical Management component and chemical manufacturers have an accurate label management solution that also produces safety data sheets.

By understanding the chemicals involved and working with sustainability experts, plant managers can evaluate their current conditions.

Executives interested in sustainable production and consumption—and being more competitive—will want to ask questions similar to these: What current waste products and materials can we use for secondary purposes or repackage and sell to someone in a different industry? Can we reuse packing materials we receive to pad and protect outgoing shipments? Are we using our raw materials effectively or are there ways we can become more efficient? How much power do our plants use? Are there affordable ways of reducing that consumption while also generating some of our own power all while meeting our long-term business goals?

Asking questions like these, and then using powerful software to find the answers, help innovative firms generate more money. That in turn can use sustainable practices to fuel growth.

The Bottom Line

Sustainable manufacturing involves looking at everything a company has, from a different angle. More office employees are working from home, freeing up space. Can we use that space for a different purpose instead of looking at empty desks? Can we move items around and expand our production facilities or our warehouse without having to build or buy new facilities?

Operations managers wanting to fuel growth by reducing power consumption can use ERP software to find ways to save money and new ways to make money. All it takes is a little outside the box long-range thinking.

The Road to Success Implementing Microsoft Dynamics 365
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Jump-starting resilient and reimagined operations
Jump-starting resilient and reimagined operations 700 500 Xcelpros Team

Jump-starting resilient and reimagined operations

Based on a wonderful piece from our friends at McKinsey, describing the effort needed by businesses moving forward after COVID disruptions. A reminder that businesses able to maintain a certain level of speed during the transition can create a significant long-term advantage.

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Migrating to the cloud through lift and shift
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Migrating to the cloud through lift and shift
Migrating to the cloud through lift and shift 700 500 Xcelpros Team

Introduction

Most businesses had never heard of cloud computing before Google CEO Eric Schmidt introduced the term on Aug. 9, 2006 even though it originated in the 1960s. During an industry conference, Schmidt was talking about the potential of network-based computing. “It starts with the premise that the data services and architecture should be on servers. We call it cloud computing,” Schmidt said.

Now, more than 15 years after the term “cloud computing” was born, the numbers show its effectiveness. A report from Hostingtribunal states:

  • 94% of enterprises (i.e., companies with more than 1,000 employees) are already using a cloud service
  • 66% of enterprises already have a central cloud team or cloud center of excellence
  • 50% of enterprises spend more than $1.2 million each year on cloud services
  • 30% of all IT budgets went to cloud computing in 2018
  • By 2025, data stored in cloud centers is expected to top 100 zettabytes (i.e., 100 trillion gigabytes)

A majority of these end-users prefer to “lift and shift” their applications into dispersed cloud server banks. Lift and shift gained prominence in the early days of cloud computing when organizations used this approach to shadow on-premise applications into the cloud.

Lift and shift is a common and simple first step toward embracing the power of cloud.

In simple terms, lift and shift means moving an application without changing the workload framework or software architecture from the existing hardware and operating system when it moves to the cloud. It is essentially rehosting your software on someone else’s distributed computing network. This approach helps companies save time, money and resources required to redesign the applications.

In this article we will touch upon the merits of the lift and shift approach and in the process find out whether moving to the cloud is worth it?

Advantages of Using Lift and Shift

The lift and shift approach is designed to help companies wanting to explore cloud computing without replacing their current software. This method is cost effective, rapid and has higher acceptance from its users because the functionality of the application remains the same.

Advantages of the lift and shift approach include:

  • Application familiarity – Moving an existing application to the cloud means the functioning and usability of the application to end users does not change.
  • Low migration costs – The program is not modified, eliminating the need and cost of rearchitecting the application.
  • Faster deployment – Since there is no need to rebuild the application, speed of delivery is higher compared to building an app from scratch.

For example, consider a Plant Manager in charge of Production Scheduling. This person has a lot to do. They need to maximize their productivity. When the company is expanding and needs to scale up its software, some form of cloud computing—public, hybrid, private or multi-cloud—is the more efficient method than doing it on-site. Replacing an existing program with a newer, unfamiliar one is likely to be met with resistance from staff unwilling to learn new methods of performing the same tasks.

Lifting a familiar program from in-house computers and shifting it to remote servers reduces the fear of change while balancing the need for agility and scalability. According to a 2018 study by IDC, 66% of the end users preferred to lift and shift their production scheduling application to the cloud for higher efficiency compared to 33% who favored keeping it on-premise.

Figure: 1Independent Software Vendors (ISVs) perceive lift and shift.

Independent Software Vendors (ISVs) perceive lift and shift.

How do Independent Software Vendors (ISVs) perceive lift and shift?

When IDC conducted its 2018 survey, 45% of independent service vendor customers preferred the lift and shift cloud migration method for moving business applications. Combined with cloud computing, 69% of end customers understand the positive implications of using cloud-based software. These include agility, scalability, cost effectiveness, efficiency and others.

Is Cloud Computing Worth the Cost?

The most important reason to move company software to the cloud, even at an initial infrastructure as a service (IaaS) level, is cost reduction. Companies save money by lowering hardware maintenance for servers, adding computing power and virtual machines plus the expense of managing the infrastructure on-site.

Using managed services can significantly lower a company’s operating costs, directly impacting its bottom line.

In terms of actual savings, the combined benefit of minimal hardware support, higher efficiency, better manageability of resources could result in a 20 – 30 % average savings on virtual machine (VM) resource configuration alone.

Upgrading an existing application on the cloud provides an integrated platform. Other resources—such as Microsoft’s ecosystem—can be leveraged, adding agility and improving speed by up to 33%. Savings can be much higher.

For example, a multinational insurer was able to save 80% on the cost of a specific development testing environment in an application suite by lifting and shifting it to the cloud. Achieving similar results demands meticulous planning and the ability to gauge savings beyond dollar value. The wider definition of savings must also include intangibles such as the value of time and money from the faster rollout of products enabled by new cloud-enabled capabilities.

Why Microsoft Azure is best suited to lift and shift your applications

There are many cloud computing platforms to choose from. Organizations looking to adopt a cloud model need to ensure everything works correctly after the move. This means interdependencies that exists between applications, data in the system and the workload continue to function even though they are now remote.

Microsoft has a transparent lift and shift process that give you a heads-up on the cost estimates before a company makes the decision to migrate. Microsoft offers a cost calculator that assesses all dependencies and variables involved in the lift and shift process. It helps better assess the migration from a complexity and cost perspective. After analyzing your requirements and determining the effort involved in the lift and shift process, the calculator determines the cost and sequence required in migrating to Azure.

Microsoft’s Azure Migrate can help plan your cloud migration with ease, ensuring you are on top of every move. The service details the mechanisms involved in the process. It provides guidance and insights to smooth your cloud journey.

Benefits of using Azure Migrate include:

  • Discovery and assessing on-premises virtual machines
  • Inbuilt dependency mapping for high-confidence discovery of multi-tier applications
  • Intelligent right sizing to Azure virtual machines
  • Compatibility reporting with guidelines for remediating potential issues
  • Integration with Azure Database Management Service for database discovery and migration

With Azure Migrate, you can be assured that your workload and application will smoothly be lifted and shifted to the cloud without any adverse impact on the business. With the right guidance and tools from Microsoft, the ROI can be maximized, while your application performs seamlessly with the highest security and reliability.

Summary

Companies unwilling to make wholesale changes to their computer software environment can still take advantage of many cloud computing benefits: they can move their existing programs to the cloud using the lift and shift method. Working with Azure Migrate allows the software and data to move with minimal impact on daily operations.

Book a assessment to know more about Azure lift and shift cloud migration abilities.

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