Software complies with CFR Part 11.
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Press Release Summary:
Windows-based software enables metal detection systems to accurately inspect tablets, capsules, and granules while meeting FDA electronic records and electronic signature requirements. Product may be accessed from PC panel integrated into company's MET 30+ Pharmaceutical unit or via remote PC. Software implements all security access controls, user identification, and audit trails so batches can be accounted for and fully traced.Original Press Release:
Lock Launches Software Solution to Part 11
Pharmaceutical manufacturers facing mounting pressure to comply with CFR Part 11 can now turn to Lock Inspection Systems for metal detection solutions. Lock 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 Part 11. The software 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.
"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;" explains Mark D'Onofrio, Vice President General Manager at Lock. "One option was to configure our detectors to fall outside the remit of Part 11, but we wanted to find a forward-looking solution. Extensive R&D has proved worthwhile as we've reached a solution that allows the unit to be operated in a compliant manner without compromising on the performance or communications capabilities of our machines."
Every Lock machine comes with full operating and framework validation documents, facilitating the installation process and maintenance of the machines, as well as satisfying GMP requirements. This means Lock's customers can rest assured in the knowledge that their machines are operating consistently to the highest standard.
Lock Inspection Systems has supplied checkweighing and metal detection equipment to companies in the food, pharmaceutical and packaging industries for over fifty years and counts many key industry players amongst its customers. Based in Fitchburg, Massachusetts, and Oldham, UK, Lock has a global network of distributors and high caliber maintenance and research teams.
For further information, please contact: Mark D'Onofrio, Lock Inspection Systems Inc., 207 Authority Drive, Fitchburg, MA 01420 6094, USA. Tel: +1 978 343 3716/800 227 5539 Fax: +1 978 343 6278 E-mail: mdonofrio@,lockinspection.com
