Whether it’s a client, a sponsor, a regulatory body, or your own team performing a mock audit, sooner or later, somebody is going to look at your training records. That means it’s important for quality teams to constantly keep them up-to-date and in a state of control. For life sciences contractors like CROs and CMOs/CDMOs that have sites and employees spread out across the globe, that’s not always easy. But there are steps these organizations can take to help keep training organized wherever they’re located. Here are three that CROs and CDMOs should consider:
Add more robust testing
You’re probably familiar with the “Read and Understood” method of training verification. After reading (and understanding) an assigned document, users check a box, sign it, and as far as everyone is concerned, they’re trained. For some documents, surface-level accountability like this might be acceptable. However, plenty of quality professionals and their supervisors will tell you they’d prefer a bit more oversight and a better way to confirm employees are properly trained, especially on critical SOPs.
That’s where SCORM training can help. SCORM is a file type that is the technical standard for eLearning programs across industries. Where Quality is concerned, the format allows creators to design and build interactive training programs that are a cut above basic “Read and Understood” methods. SCORM files add more depth to training by pairing quiz questions with audio and visual components that can more accurately test a user’s grasp of the material. SCORM also allows admins to quickly check the results of each users’ score to determine if retraining needs to take place.
For CROs and CDMOs in particular, SCORM-based programs are a more robust way to prove to sponsors, clients, and inspectors that employees are properly trained on their relevant materials. To add this level of reassurance, make sure you have an electronic quality management system (eQMS) that can host SCORM files.
Focus on traceability
The auditor is waiting…do you know where your effective SOPs are? For CROs and CDMOs with remote testing facilities and manufacturing sites, it’s tough enough enforcing compliance, let alone making sure everyone is training on the most up-to-date documents. Paper-based QMS solutions make it difficult to get timely signatures from site to site and increase the chances of documents getting lost in the shuffle. And with every facility acquired and employee added, a company’s training matrix can quickly spiral out of control. The reality is, if additional complexity affects your ability to locate the right document quickly, training compliance is now at risk. This isn’t the look you want to present to an inspector or potential client.
Here’s the thing - moving to the cloud is only half the battle. Sure, an Excel file might be easier to find on a server compared to a filing cabinet (provided there aren’t multiple drives with different naming conventions), but just because it’s in the cloud doesn’t automatically mean it’s 21 CFR Part 11 compliant for electronic signatures. An auditor or potential client will expect some proof.
The solution to keeping quality documents and SOPs traceable and in a state of control is to migrate them into a validated eQMS, where they can be stored securely and immediately accessed by everyone (with proper permission, of course). Even better, once inside the system, training documents can be automatically updated to the latest version, giving quality leaders one less thing to worry about. No more walking around a facility with a stack of SOPs, swapping out the old ones for the latest versions!
“The training features were superior to other solutions, our entire company could access the system, and ZenQMS was more affordable. It was almost night and day.”
- Neil Sharma, General Manager at Boston BioProducts, a CDMO providing custom buffers to thousands of labs worldwide
Utilize a training dashboard
With many CROs and CDMOs spread across multiple sites, staying audit-ready at all times can be a challenge. That’s why having instant visibility into company-wide training status is so important. The faster you can see who’s overdue on their training, the faster you can alert them and get them back on track. The same is true for regulatory, sponsor, or client audits; the faster you can provide them with the information they’re looking for, the better.
That’s where a training dashboard comes in. The dashboard is essentially a snapshot of who’s compliant, who’s overdue, and what training courses they’ve been assigned to. For a quality administrator at a CRO or CDMO, it’s ideal because they can have the data at their fingertips in seconds, and can quickly pass it along during a remote or on-site audit. The training dashboard is a useful tool for employees as well, because a quick glance tells them exactly what’s expected as far as training is concerned.
An eQMS, especially one that’s intuitive and easy-to-use, will come standard with a training dashboard. So instead of sifting through binders, filing cabinets, and multiple cloud drives just to get a compliance report, CROs and CDMOs can have training status information delivered in just a few seconds, with just a few clicks, down to the individual, course, or group. And intuitive infographics allow quality leaders to dig into details more efficiently without the fear of anything falling through the cracks.
“ZenQMS has made the lives of our managers and QA folks so much easier because the training matrix is intuitive and we can see exactly which groups everyone is in and what courses they’re assigned to. And it drives up compliance. Paper doesn’t turn red when you’re overdue.”
-Quality Administrator at Precision Medicine Group, a global CRO specializing in the development and commercialization of pharmaceutical products.
With that kind of visibility into company-wide training status, combined with automatic notifications from the eQMS about upcoming training for all employees, imagine how much easier it will be to keep everyone compliant. And for remote audits, the same control applies. An eQMS makes it easy to provide inspectors with view-only access into an audit account with exactly the documents they’ve requested, while protecting everything else.
If you’re looking to improve compliance at your CRO or CDMO, ZenQMS offers the configurability and capability necessary to strengthen and organize existing training while providing near-instant company-wide visibility in an easy-to-use, validated platform. For more information, talk to us and find out how we take the stress out of eQMS.