Compliance is like water: If you don’t know how to manage it, you’ll drown. If you manage it carefully and proactively, you’ll thrive.
High-consequence industries can’t afford to turn a blind eye and ignore government regulations, especially in life sciences. The repercussions of a compliance fallout are costly, and I’m not exaggerating! The average cost of non-compliance runs an organization an estimated $9,000,000 annually.
Proactively maintaining compliance is not as simple as finding a technology solution to help you check a list of requirements. Food and Drug Administration (FDA) driven mandates are particularly complex. Organizations must follow a very detailed set of principles and procedures during each stage of the manufacturing process to ensure products meet specific standards. This involves everything from raw materials, facilities, and equipment standards to the training and hygiene of staff.
It makes sense, right? Life sciences organizations exist to keep society safe and healthy, and it’s the FDA’s responsibility to hold them accountable.
However, FDA-regulated mandates—specifically Title 21 of the Code of Federal Regulations Part 11—put intense pressure on product quality assurance teams to deliver, manage, and report on training.
Before I lose you with the legal stuff, let me back up and explain Title 21 CFR Part 11 and how it impacts training and development.
Individuals with various roles and responsibilities throughout the product development lifecycle must complete specific training courses to ensure safety and product quality control. But it isn’t as simple as an individual enrolling and completing a required training or certification course. Title 21 CFR Part 11 requires organizations to ensure that electronic records, e-signatures, and handwritten signatures are as trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
That’s where things get a little tricky.
For decades, organizations have leveraged learning management systems to automate, deliver, manage, and track training. However, in life sciences, not every LMS meets the feature, functionality, and deployment model requirements of Title 21 CFR Part 11. Selecting the right LMS for your life sciences organization can feel daunting, especially when you need to understand and identify the functional, operational and technical requirements of the solution.