Written by: Katie Favino, Business Development Manager
Switching from your existing paper-based Quality System to an Electronic Quality Management System (EQMS) can be a very scary undertaking. If you are considering making the switch, sooner is much better than later. As your company grows, while bringing your product to market, information gets much harder to track, perform in the proper order, and able to find (especially when everyone is working in a different place) on paper.
Organizing and Uploading Current Documents
Prepare for Implementation. We recommend creating your master document list, locate and identify all current paper documents to ensure inclusion. Don’t forget any electronic versions (word documents, excel sheets, pdfs, etc.) and document templates.
Determine which workflows your new EQMS comes with. Controlled Documents, CAPAs, Deviations, Investigations, Out of Specification, Complaints, and Training are all critical workflows to have at your FDA-regulated company. If your new EQMS is pre-configured, ensure it comes with the workflows that you need now and ones you’ll need later, as you grow.
Identify at least two persons in your organization as the System Administrators who will be in charge of adding new users and assigning their roles within the system. Who should be able to do what in your new system? This is an essential piece to your EQMS. Quality Assurance and the System Administrator need to work together. Identify the people for these roles and document your procedures accordingly.
Does your new EQMS come validated or do you need to complete validation? Fully validated, ready-to-use systems will save you lots of time. Upgrades will always take place through the life of a system. It’s important to understand if upgrades are included in the price of your system, and who is responsible for the revalidation activities.
Once your new EQMS is implemented, train your employees. Read any user guides that are provided with the system. Hopefully your new EQMS comes with an integrated Learning Management System! If it doesn’t, track your training information elsewhere. Does your system come with a Sandbox instance that can be used for training purposes? Sandbox instances are extremely beneficial when training employees on new software.
Our best advice is once you decide to switch to an Electronic Quality Management System, start your search, choose your system, and implement it as soon as possible.
PSC Software’s, ACE Essentials™, comes with fully validated document control, quality management and learning management workflows all in a 21 CFR Part 11 compliant system that can be accessed on any device with internet connection. It can be implemented in as little as one week, as long as all of your documentation has been organized and is ready to be uploaded. We provide over 50 generalized, best practice documents to start-up your system. You can adapt these procedures to your process or upload your most current version to be approved. This system was built specifically for start-ups and small sized companies that are looking for a compliant, turn-key solution, at a cost-effective price. Reach out to PSC Software today to learn more.