Organizations that manufacture food, pharmaceuticals, or medical equipment are required by the FDA to adhere to strict processes in the production of products.
Collectively, these processes are known as GxP practices, and among these is the requirement that employees complete mandatory compliance training to stay current on the processes and procedures required to do their jobs. Companies must also provide training records to prove they’ve consistently and accurately assigned the right training, at the right time, to the right employees to stay in compliance with 21 CFR Part 11. To do so, the organization’s LMS must be in a validated state. In this post, we will explore the signs that your LMS may need to be validated and the steps you should take to address.
Sign #1: You’ve Never Heard of LMS Validation
If you are an LMS administrator for a Life Sciences company, and this is the first time you are hearing about LMS validation, your LMS may be non-compliant. Perhaps you are new to the industry, and if so, keep reading. This is a great resource to learn about LMS validation. However, if you have been supporting learning and development within Life Sciences organizations for years, and this is the first time you’ve heard about LMS validation, GxP, or 21 CFR Part 11, it’s time to investigate. If you learn that your system was validated at implementation, but most likely has fallen out of compliance, skip to Sign #2. If you learn your system was never validated, skip to Sign #3 to learn more about what will be required for validation.
Sign #2: Nobody is Managing Your Validated LMS
If you vaguely remember going through the validation process during implementation, but nobody has been responsible for actively managing it, your validated LMS is likely non-compliant. The good news here is that during the implementation you took the time and the steps to create a validation plan, document, and test your requirements. The question will be, have you kept up with the releases that Cornerstone, Saba, or SuccessFactors has been pushing to the system. It is best practice to consume these updates from your vendor, not only to support improved functionality and features, but to also reduce the validation burden from becoming too much by only validating once a year. If you still have your configuration workbook from your initial implementation, check to see if it has been updated with any changes your organization has made or that have been pushed out through new releases since go-live. If not, start there. For guidance on understanding change control in a validated environment, check out these two blogs: one focused on the basics and the other focused on keys to success.
Sign #3: You’ve Never Validated Your LMS
It goes without saying. If you’ve never validated your LMS before, there’s a high likelihood that it is non-compliant. There can be several reasons why this may be the case, including:
- You have been using manual or paper processes to track and report on compliance training
- Your business has historically operated multiple LMS platforms, but has decided to consolidate to one system
- A strategic acquisition was made and now you have new stakeholders subject to the regulations that need to be added to your existing LMS.
Regardless of the business driver, if you are now required to maintain a validated LMS, consider the steps below to ensure that you validate appropriately.
- Step 1 – Start by gathering your requirements and auditing your current LMS state against those requirements. For example, do you need to enable electronic signatures? Do you need to migrate any historical data for reporting or assignment purposes?
- Step 2 – Document your uses cases and identify where you need to learn more about certain functionality. For example, do you have the right meta data on your users record or do you have updates that need to be made with your HR feed? Do you plan to use curricula to support qualifications, or stand-alone courses?
- Step 3 – Review your existing reports and auditing. Are there existing reports that will be used to support internal and external auditing? Do you need to create new reports to support this process?
- Step 4 – Understand your timeline and any impacts to your cutover and go-live plan. Your goal should be to minimize the time that your users are unable to access training.
If you find that one of these three signs sound all too familiar, take the necessary steps now to begin the process of validating or re-validating your system. For Life Sciences organizations, implementing and maintaining a validated LMS is crucial to continuing business operations and ensuring regulatory compliance.
Visit our Life Sciences page to learn more about how Educe can help support your LMS validation efforts.