FDA Compliance / Automation

Validation of Automated Systems for FDA Compliance

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FDA also intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period, and any corresponding requirement. Persons must still comply with all applicable predicate rule requirements for record retention and availability. We suggest that your decision on how to maintain records must be based on predicate rule requirements, and that you base your decision on a justified and documented risk assessment and a determination of the value of records over time.

FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper or standard electronic file format (examples of such formats include, but are not limited to, PDF, XML or SGML). Persons must still comply with all predicate rule requirements and the records themselves, and any copies of the required records should preserve the meaning and content.


As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. In addition, paper and electronic record and signature components can co-exist (i.e. hybrid situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved.

Application and Benefits of FDA Appliance

The compliance to 21 CFR part 11 offers several benefits, such as – cost benefits-by aiding the production of systems that are fit for purpose, meet user and business requirements, and have acceptable operation and maintenance costs; better visibility of projects to ensure delivery on time, on budget, and to agreed quality standards; increased understanding of the subject and introduction of a common language and terminology; reductions in the cost and time taken to achieve compliant systems; improved compliance with regulatory expectation by defining a common and comprehensive life cycle model and clarification of the division of responsibility between user and supplier.

As an example, consider the application of BPCS (Batch Process Control System) in one of the plants of Glaxo SmithKline. The size of the automation system is approximated at 4500 I/O, 40 batch operations of varying sizes, over 800 programs and approximately 580 process and safety interlocked measurements. With the exception of three small annuciator panels, the BPCS provides entire operator interface for the various

automation systems. The majority of the initial programming was performed by the engineering firm contracted to provide the detail design and construction of the three units. As a result of this contract, various electronic files of software documentation were provided to plant personnel upon startup.

The plant automation support group decided to maintain these documents as they were an invaluable tool for troubleshooting and optimising such a vast amount of software. Because of the closely scheduled start-ups, this period proved to be very active for the software of all three units. Therefore, it was desirous to have a method to document what modifications had been requested, and which requests had been completed for any given unit since the last shift cycle.