GOT2000 meeting the requirements of FDA 21 CFR Part 11

This regulation establishes the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA.

Part 11 applies to all GxP (i.e. GMP, GLP and GCP) IT systems that create, modify, maintain, archive or retrieve electronic records. If the organisation is a pharmaceutical, biological or medical device manufacture whose products are made for sale within the USA then Part 11 applies.  The regulation covers four key areas:

Data Retention

Electronic records must be retained and be retrievable for as long as the requirement for the equivalent paper record.

Security

Access to electronic records must be restricted to authorised personnel only.

Audit Trail

All operator entries that create, modify or delete an electronic record must be recorded in a secure, computer generated audit trail identifying operator ID, authorisation ID and time stamp.

Signature Form

Maintenance typically of ID and password details, including access/authority hierarchy, password aging and access details.

Most of these requirements can be met within the control system through the use of Mitsubishi Electric GOT series HMIs and other data management products. GOT HMIs allow different levels of security controlled access to be established, from system operators to system administrators. Time stamped audit trails are maintained to record the date and time of operator entries and actions that create, modify or delete electronic records.

Secure data storage and Store Forward Capability

GOT HMIs also allow data to be stored securely, complete with validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. In addition, the HMIs provide the ability to generate accurate and complete copies of records in both printed and electronic form.

Data is stored within the GOT HMI on CF cards, and cannot be overwritten or deleted. Instead, new records are added when authorised changes are made. In addition using “Store Forward”, electronic records can be pushed (on an event or time basis) to a 3rd party secure database such as Microsoft SQL Server thus providing a resilience to data loss as part of 21 CFR 11.

GOT series HMIs can be readily configured to ensure users follow a permitted sequence of steps when operating the system, as defined under the FDA 21 CFR Part 11 requirements, with the graphical user interface covering all possible operational modes.

For full details of implementing Mitsubishi Electric GOTs to meet the requirements of FDA 21 CFR Part 11,