Real-time Access Plant Information Database from Automsoft International now complies with the FDA 21CFR Part 11 standard for electronic records and electronic signatures. A new version of the package, called Rapid-Pharma, is claimed to be the first plant information management system to offer compliance with the specification as standard. Users will be able to keep complete audit trails of their electronic records in a highly secure system.
Rapid-Pharma stores process and batch record data in a secure database. A complete audit trail of all human interactions with batch production records – such as data entries, modifications and deletion – is maintained with the system in a separate audit database. This may reside on the same hardware as the process and batch record database, or on a separate system.
According to Ian Pepper, Automsoft’s Chief Technology Officer: ‘The ability to run two independent databases is a big security advantage for this type of solution, as the audit database can be completely isolated from the process and batch database.’
Feedback from the pharmaceutical and food industries suggests that data integrity and security are key requirements, which have been incorporated into Rapid-Pharma. The package utilises C2 compliant Windows NT and Windows 2000 security managers. Rapid-Pharma’ s security features support the management of identification codes and passwords such as expiry dates, password definition rules, or retry locking. Any attempt to access the system or edit data is recorded in the audit trail.
Rapid-Pharma enforces the individuality of user ID codes and electronic signatures through appropriate controls and a complete user history. This is particularly important because the audit trail could be the only evidence that an electronic record has been modified or deleted.
The audit trail automatically tracks all user interactions and changes in the system including the creation of new database points, the addition of new equipment, manual ingredient additions, and data back up. The integrated XML based reporting tool allows the generation of user reports, which can then be securely transmitted to any interested party.
A core aspect of 21 CFR Part 11 compliance concerns the issue of data loss. Ian Pepper continued: ‘The FDA stipulates that although data may be deleted from the database, you must still be able to recover from the electronic records and this presented us with an interesting technical challenge.’
The package already offered this functionality, demonstrated in its use of zero loss data compression technology. In Rapid-Pharma, the function has been further extended so that a two phase commit approach is employed before data may be deleted from the plant information management database.
The product is currently being used by a number of leading US Pharmaceutical companies in their production environments.