What are the main reasons that so many life science companies are using a Manual Paper QMS instead of digitizing their Quality Processes? The key topics are:
- “It takes too much time”
- “The price is too high”
- “Vendors are unaware of the regulatory requirements”
Some learnings in the video are:
- Don’t try to digitize too many processes at once. You will be waiting too long for the benefit.
- Look for standard-solutions, which are not paid by Time and Materials
- Ask vendors about their certifications and regulatory experience
SimplerQMS is a Part 11 Compliant, Ready-to-use eQMS for Life Science Companies. We deliver a Validated Cloud Solution, we enable your company to work efficiently and paperless, while being in compliance with the regulatory authorities. Let us help you save time and money by digitizing your Quality Management System, Training, Design History File, Issues & CAPAs. SimplerQMS is ISO13485:2016 certified and in compliance with ISO14971:2019, FDA CFR 21 Part 820, FDA CFR 21 Part 11, EU MDR and GDPR.