Introduction

Speed and accuracy are fundamental for any business, including the pharmaceutical industry. Microsoft Dynamics 365 for Finance and Operations (F&O) offers an intelligent cloud-based solution tailored to meet the pharmaceutical industry’s needs.

With the help of Dynamics F&O, pharma companies can reduce regulatory burdens, introduce automation, boost productivity and build a secure environment focused on achieving high-value work.

Pharmaceutical companies often prepare medicines with diverse formulas. Much of the focus is placed on raw material quantities, yields with constant and variable scrap percentages, and operations within production. Pharmaceutical companies need an enterprise resource planning (ERP) system that monitors functions such as procurement, production and supply chain operations.

Microsoft Dynamics F&O Features for Pharma

Feature Function
Product quality and safety Manage:

  • Multi-stage tests of raw materials
  • Lot expiration, stock aging and re-testing requirements
  • Supplier information such as vendor batch details/ expiration dates on raw material batches
  • Integration of quality management to inspect incoming raw materials
Sales and promotion management Manage:

  • Leads, prospects and customers
  • Delivery orders, sales contracts and export invoices
  • Discounts and price lists, including competitor analysis
Processing and packaging
  • Trace inventory including lots, batches and serial numbers
  • Generate bar code labels for packaging and shipping
  • Integrate with real-time data collection systems like PLC and SCADA
Financial control
  • Provide insights on intercompany purchases and sales
  • Track batch costing for planned vs. actual

1.CRF 21 PART 11 Compliance

Pharmaceutical companies are constantly searching for ERP systems that offer 21 CFR part 11 compliance. This FDA rule requires companies treat electronic records and signatures like paper records and handwritten signatures. Companies keeping any electronic records are required to comply with the regulation.

Pharmaceutical manufacturers require software that’s able to meet changing regulations. Integrated Pharma ERP systems track document revisions. They provide an audit trail of comments stating how members or groups interact with the documents. Effective software also boosts data security and includes intelligent document control.

Pharma manufacturers are using digital documents instead of paper for daily operations. CFR 21 Part 11 requires a legally bound signature to ensure its integrity. Microsoft Dynamics F&O includes this function. ERP software lets company owners relax in terms of digital document authenticity and validity. When an ERP system checks for electronic signatures, it looks for notarization, non-repudiation and integrity.

2.Inventory Management

Pharma companies constantly face inventory management challenges, including temperature control, inaccurate counts, poor warehouse management, imbalances in inventory supply, and even failure to shed excess inventory. A powerful ERP program helps eliminate these common problems.

Tracking expiration dates is another part of inventory management. When done incorrectly this can quickly add up to big costs for pharma companies.

An effective ERP inventory program such as Microsoft Dynamics 365 Supply Chain Management not only tracks inventory shelf-life, it can also track and trace lots, batches and individual products. This solution from Microsoft is also able to verify batch potency, generating notifications to the business owner about their products’ quality.

Dynamics Supply Chain Management also goes well beyond visual inventory counts. Using barcodes or QR codes, employees with handheld scanners or cell phones can use its mobile supply chain management features. These include recording real-time inventory counts during operations. Chief executive officers can verify inventory at any time, including pick and put away or when raw materials are consumed.

Figure: 1ERP for Pharma

ERP for Pharma

Another part of keeping accurate inventories is generating reports, like those dealing with aging. Reports provide a breakdown of inventory quantities and values by various dimensions such as batch, serial number, site, warehouse, location and license plate number. Dynamics Supply Chain Management includes many reporting features.

3.Transparency and Traceability

In the pharmaceutical industry, transparency and traceability is a complex issue. Companies need to keep track of product families, dosages, lot numbers, schedules, strengths, global trade item numbers (GTIN) and National Drug Code numbers. The Supply Chain Management module tracks product code, NDC number, brand strength and dosage.

Pharma firms also need end-to-end lot traceability. This comes in handy for recalls. Dynamics Supply Chain Management can notify all customers who receive the recalled batches without forcing employees to struggle through mountains of paperwork.

4.Quality Control

Quality control in an integrated ERP manages testing on raw materials, intermediates and finished products. Using an ERP to compare data ensures that raw materials meet agreed-upon standards.

For example, an ERP can quickly identify and provide the list of affected or remaining lots, and can even provide supplier details. Every pharma manufacturer wants to know their products are in compliance with FDA requirements to avoid penalties and fines.

5.Shipping

Dynamics 365 Supply Chain Management includes powerful lot and batch tracking functionality. It lets department leads monitor batches from the start to in-process quality control (IPQC). Executives have a program that reports delivery status as soon as items are scanned into the system.

Final Thoughts

Moving forward, the Pharmaceutical industry will continue to face increasingly stringent regulations. Companies seeking to keep up with ever-growing innovations in market trends, changes in the health care sector and rising global competition will need all the help they can get. An enterprise resource planning solution like Microsoft Dynamics 365 helps companies overcome these challenges everyday, while simultaneously reducing costs, streamlining operations and most importantly, helping businesses remain compliant.

Book a free assessment to get started with tailored ERP solutions for pharmaceutical manufacturing.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

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