FDA 21 CFR Part 11 / Clean room monitoring

Secure and tamper-proof data storage

One requirement of manufacturing, but also increasingly of R&D and pharmaceuticals, is data acquisition and documentation that is continuous and tamper-proof. The FDA (Food and Drug Administration) have drawn up a regulation (FDA 21 CFR Part 11) to ensure the adherence to process data limits, such as temperatures, that are based on GAMP/GMP-guidelines. The regulation also requires that this data, and limit violations, are securely recorded and are tamper-proof.

An audit trail is further required to log any events that affect processes.

Alarms and user management

Alarm systems must exist which are capable of notifying authorized persons (email, fax, text messaging) and of triggering, when necessary, pre-defined procedures.

An advanced system of user management is likewise necessary so that only the authorized person is able to confirm the alarm. Such a system should function according to user groups of different users and rights. GAMP/GMP guidelines require alarms to be confirmed with comments.

Checking for long-term stability

For example, pharmaceuticals are stored in cold rooms and deep freezers during testing for their long-term stability. The secure and tamper-proof recording of temperatures is just one requirement. Another is a system of alarms for temperature under/overruns along with the input of comments by an authorized person, password-protected login, and automatic documentation for cold room malfunctions or interventions.

Secure measurement data acquisition occurs within a data server and redundant data acquisition within the hardware device. This guarantees continuous data recording even in the event of a network or server failure.

Single package solutions

The Expert and Message series, the ProfiSignal software, and the FDA 21 CFR Part 11 option provides users with a complete package for data acquisition, process control, reporting, user management and alarm management. Inobalt products also deliver the information required for validation, IQ (installation qualification) and OQ (operational qualification).