How ERP Solutions Benefit Pharmaceutical Manufacturers

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

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. 21 CFR 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.

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.