Like it or not, we are all becoming experts on how new devices and drugs, including vaccines, get to market. Whether it’s ramping up production of already in use devices (like ventilators), or starting from scratch on a new vaccine - the process is data intensive. A lot of data gets exchanged with the regulators, like the FDA, in the form of documents. Those documents need to be carefully controlled from the time of creation through review, approval and consumption. Regulators like the US FDA have a lot of rules that dictate what kind of controls must be in place before a vendor can submit files to the FDA.

Quality Document Management from ENOVIA provides the foundation for meeting the needs of the heavily regulated Life Science industry. This includes compliant electronic signatures, version control, a robust audit trail and a task based approval process. Having this application as part of an overall platform approach can make a big difference in how fast critical needs can be filled.

The need for Quality Document Management isn’t limited to the Life Sciences industry.  Industries like Aerospace & Defense have very similar requirements. As part of our commitment to total quality, ENOVIA offers a complete set quality applications including Quality Document Manager for documents, Quality Manager for processes like CAPA’s and non-conformance’s and Regulatory Affairs Manager for regulatory management.

https://ifwe.3ds.com/life-sciences/license-to-cure-for-biopharma

https://ifwe.3ds.com/life-sciences/total-quality

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