Question

Q.reduce GxP also known as options 1.predicate rules 2.assert rules 3.none of the above 4.all the above​

Answer 1

The correct answer is OPTION 1: Predicate rules

• FDA Compliance Requires an Understanding of GxP Predicate Rules Part 11 of the FDA's 21 CFR.
• According to 21 CFR Part 11, also known as Part 11 in popular usage, electronic records, and signatures are just as valid as paper records and handwritten signatures.
• When it was passed in 1997, the regulation was hailed as a watershed moment.
• Previously established regulatory standards that pertain to paper-based systems, known as FDA predicate regulations, can now be met with electronic record-keeping systems.