21 CFR part 11

With the greater use of information technology and computerisation, electronic records and signatures are having a significant effect on the pharmaceutical manufacturing industry.

FDA rule 21 CFR Part 11 details procedures and regulations for specific control and use of electronic records within a strict administrative protocol.

Keeping pace with change, Optimal has developed and installed a number of systems that implement the 21CFR Part 11 requirements in both new and legacy systems.

If you expect your process procedures to fall within the scope of the new code, an early discussion with Optimal could provide you with a cost effective practical solution.