Compliance is like water, if you don’t know how to manage it, you’re going to drown. If you carefully and proactively manage it, you’re going to 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 per year.¹
Proactively maintaining compliance is not as simple as finding a technology solution to help you checkoff a list of requirements. Food and Drug Administration (FDA) driven mandates are particularly complex. Organizations are required to 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.
Makes sense, right? Life sciences organizations exist to keep society safe and healthy and it’s the FDA’s responsibility to hold them accountable.
But, 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.
Hold up, 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.
Throughout the product development lifecycle, individuals with various roles and responsibilities are required to complete specific training courses in order 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 executed electronically 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 been leveraging 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.
Don’t freak out! We put together a really useful report on the “Definitive Guide to Managing and Maintaining Compliance in Life Sciences,” which is complete with the ultimate LMS selection checklist to help you navigate the choppy waters of compliance.
¹Ponemon Institute, “The True Cost of Compliance: A Benchmark Study of Multinational Organizations,” 2011