This industry is broad and unique in many ways, mainly because it “develops” as companies go through the life cycle from pre-clinical phases to the approval or market phase. There are distinct requirements at each phase of the life cycle. Here are the top five features to look for in an ERP solution for Life Sciences.
1. Serial and Lot Number Traceability
You hope the day never comes where your product has quality issues that trigger recall activities. But recalls happens, and when they do, fast and accurate trace and track capabilities are key because, when it comes to saving lives, every minute matters.. Your ERP must have the ability to identify the location of every component whether it’s in stock, in finished goods or at a customer’s site. It also makes business sense to understand the quality of your products in order to make improvements to them. Another key aspect is the ability to assign both a serial number and a lot number to components.
2. Electronic Signatures
Meeting the FDA requirement of 21 CFR part 11 where people who complete work or inspections on products must provide a unique and clearly readable signature. There must be specific, identifiable and verifiable signoffs. Most notably, the electronic signature needs to be controlled biometrically or require two forms of validation: a password and a user code. This requirement goes well beyond the typical user account logging into typical ERP systems.
3. Quality Management System
The Life Science industry requires an ERP system with more sophisticated quality assurance and management capabilities. For instance, the ability to record detailed test results by serial number, or verifying test procedures and scripts during testing. Capturing information about multiple quality aspects could result in a pass or fail designation. These complex quality needs mean that Life Science companies need an ERP system with a built-in, full feature quality management system.
4. Streamlined Compliance through Document Management
Ensuring adherence to current processes and procedures is fundamental to compliance. Paper-based documentation for drawings, processes, and procedures is risky. An electronic document management system ensures that the latest revision of every document is always present during the production process. An advanced document management system also reduces time spent printing, filing and storing documents while reducing errors and rework.
5. A Validated Environment
ERP systems in the Life Science industry need to be validated to prove regulatory compliance. Properly validated processes and systems are a prerequisite in most Life Science markets in the world. Failure to validate can lead to observations and warning letters from the FDA. The best way to achieve process optimization with respect to validation is through automation. Just as is the case with ERP automation, validation automation can take your company to higher levels of mastery and compliance excellence.
More than any other industry, Life Sciences companies need an ERP system that is specifically built for the industry. Perhaps the sixth key feature is an ERP partner who understands the intricacies of the FDA and is aware of the devastating penalties for non-compliance. There is no need to compromise with your ERP system but having it all from track and trace through quality management and document management to global supply chain visibility.