Technology is leaping ahead in terms of the information it can provide and record electronically. Unfortunately, where old regulations dictate the use of paper systems, the technology is not being used to its full potential.

This has become apparent in the pharmaceutical industry, and as a consequence a consortium of companies has joined with the Federal Drug Administration (FDA) in America to develop regulations to allow the use of Electronic Records (ER) and Electronic Signatures (ES) in place of paper records and hand-written signatures. This has now become the regulation FDA 21 CFR part 11.

Many solution providers can now supply products that are 21CFR11 compliant.

Silchester has presented papers and is contracted to consult on 21 CFR part 11 solutions.