Metal detection software complies with 21CFR Part 11

Published: 1-Jul-2003


Metal detector specialist Lock Inspection Systems has collaborated with industry experts to develop software that enables metal detection systems to deliver highly accurate inspection of tablets, capsules and granules while at the same time meeting the electronic records and electronic signature requirements of the FDA. The software can be accessed from either a PC panel integrated into Lock's MET 30+ Pharmaceutical unit or a remote PC.

Developed according to GMP guidelines, the bespoke Windows-based software allows pharmaceutical companies to comply fully with 21 CFR Part 11: it implements all security access controls, user identification, audit trails, electronic records and electronic signatures, so in the event of contamination, batches can be fully traced and accounted for.

Lock has designed a user-friendly industrial PC panel incorporating the Part 11 software that can be integrated into its MET 30+ Pharmaceutical unit. The PC panel replaces the detector's user interface, so product set-ups, tests and diagnostics are run from the machine itself. Alternatively, companies with restricted line space or with a number of metal detectors can operate the software from a remote PC which is permanently networked to all the detectors. In this way, reports are transmitted to the PC instantly rather than being stored in the detector. Diagnostics, set-up and interrogation routines are performed via the PC.

Every machine comes with full operating and framework validation documents, facilitating the installation process and maintenance of the machines, as well as satisfying GMP.

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