Ensure CFR 21 part 11 compliance with OpenText's Electronic Signature solution for QC/ALM and Value Edge

3:20 PM - 3:40 PM
Electronic records are most certainly the norm today, steadily proliferating since the early 90’s, and in many industries, where one of the most regulated is life sciences! The only way life sciences manufacturers are allowed to use electronic records and signatures is to comply with FDA regulations CFR 21 part 11.  Failing to meet compliance rules can introduce risk and safety issues within your products, potentially putting customers lives at risk, not to mention being damaging to your brand and eventually your bottom line. This quick talk is on how Opentext addresses the electronic signature of records with core products such as Quality Center ALM, Octane and Value Edge, ensuring compliance with regulations and giving you that peace of mind should you be subject to an audit while streamlining your product lifecycle processes. Let’s talk!