Regulation 21 CFR Part 11 provides detailed guidelines on how to create and manage electronic records and signatures. Compliance is obligatory for all FDA-regulated industries.
The key objectives of 21 CFR Part 11 are:
In this webinar, we explain the scope and requirements of 21 CFR Part 11. We then explain the solutions offered by our STARe software. This includes the features of the 21 CFR Part 11 software option that allow users to work within a compliant system.