UK firm Lock Inspection Systems has developed a software package for use alongside its metal detection systems that will make it easier for pharmaceutical manufacturers to comply with the US Food and Drug Administration's 21 CFR Part 11 regulations.

The software enables metal detection systems to deliver accurate inspection of tablets, capsules and granules while at the same time meeting the electronic records and electronic signature requirements of the FDA, according to Lock.

The package implements security access controls, user identification, audit trails, electronic records and electronic signatures, so in the event of contamination, batches can be traced and accounted for.

In tandem with the software development, Lock has also produced a PC panel that can be integrated into its MET 30+ system, designed for use by pharmaceutical manufacturers. However, the package can also be run on a remote PC if line space restricted.

"Given that the onus to respond to Part 11 falls on machinery suppliers as well as pharmaceutical manufacturers, we've invested considerable time and resources into evaluating all the possible options for compliance," explained Mike Randall, Lock's chairman.

Part 11 was introduced in 1997 as a requirement for controlling electronic records and electronic signatures in validation and Good Manufacturing Practice.