In our next article in the series of the 10 requirements Life Sciences companies need addressed by their industry specific ERP systems, we cover the next three capabilities: Inventory Storage, Quality Management, and Document Management.
(In our previous articles we covered: Traceability and As Built / As Maintained Configuration Record; Electronic Signatures, Engineering Change Notice, and Effectivity Dates and Phase-Ins.)
Inventory Storage and Transaction by Revision and Lot
During recalls and audits, the focus is often on units in the field, but there may be affected items in stockrooms, including finished goods. In addition, there may be limitations on the use of certain older revisions of components and sub-assemblies.
When this is the case, having the ability to store materials with a revision, lot and serial number can improve inventory planning, decrease material shortages, reduce potential rework and help identify limits during recalls or ECN implementations.
General purpose ERP systems rarely include this capability, while those designed for Life Sciences and High-Tech manufacturing frequently do. Having this capability can replace manual validation and save time and money while reducing errors.
Quality Management System
Most general purpose ERP systems have—at best—basic quality tracking information that simply records pass or fail data at designated steps in the routing. With its more specific process tracking requirements, the Life Sciences industry requires more sophisticated quality assurance and management capabilities.
Life Sciences companies may require the ability to record detailed test results by serial number, or to verify the test procedure and script used during testing. They may have a need to capture information about multiple quality aspects, any one of which—or any several in combination—could result in a pass / fail designation. These complex quality needs mean that Life Science companies need an ERP system with a built in full featured quality management system (QMS).
Some general purpose ERP suppliers may suggest creating an interface with a third party QMS. However, this interface needs to be completed by experts because poorly integrated or partially integrated QMS can cause errors, inaccuracies and production delays. An integrated QMS solution enables companies to record quality results and capture necessary electronic sign offs as a standard part of their process. This simplifies recalls and ensures that steps and signoffs don’t get overlooked.
Document Management
Ensuring adherence to current processes and procedures is fundamental to compliance. The use of paper documentation for drawings, processes and procedures is risky. People tend to store paper versions of documents, and they may inadvertently use old or outdated processes as a result. Electronic document management, on the other hand, ensures that the latest revision of every document is always presented for use during production. In addition to reducing errors and rework, a state of the art document management system reduces time spent printing, filing and storing documents.
To learn more about ERP in Life Sciences companies, download our free “ERP in Life Sciences” white paper.
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