Customer Login21 CFR Part 11 / Annex 11
With the arrival of electronic technologies, the pharmaceutical industry, like other industries, realized that migrating paper-based processes to electronic processes would make drug development more efficient and allow them to reduce time-to market.
However, for companies operating in the Life Sciences industry, the FDA requires that electronic records and electronic signatures are certified, trustworthy, reliable, and essentially equivalent to paper records and handwritten signatures as described in 21 CFR Part 11. Users of the Kneat Gx application can rest assured that their data is fully protected according to the regulatory requirements.
For more information, refer to our comprehensive Kneat Gx 21CFR Part 11 Compliance Statement.
