ISO 13485: 2016 and its relationship with Computer Systems Validation
The newest edition of ISO 13485 was a new approach on the validation of productive processes using computer systems. They are covered by this new approach from high level language software like as ERPs, production control systems (MES) to more rudimentary systems such as industrial equipment managed via PLCs, CNCs and computerized machining units.
A summary of the requirements of ISO 13485: 2016 for Computer Systems Validation is described below:
- An organization should document procedures for validating the application of quality management system monitoring software, such as using monitoring software for product monitoring and measurement requirements, on systems used in the production and delivery of service. Such software must be validated prior to initial use and, as appropriate, after the change of software or its application.
- The approach and tasks specific to software validation and validation should be proportionate to the risk associated with the use of the software, including the effect on the ability to conform to specifications.
- Records that the results of validation, validation and validation of the information should be kept.
- An organization shall document the installation requirements necessary to comply with the requirements of the product, prevent a mixture of products and ensure orderly handling. The infrastructure includes process equipment and / or support services, such as information systems.
ISO 13485: 2016 despite these requirements does not indicate or reference any guide or standard for these computer systems validation processes. ANVISA has published a manual to help Brazilian manufacturers and distributors in their Guide to Computer Systems Validation (in portuguese), 2010 with great tact to introduce the theme.
The best validation guides for operating systems are:
- FDA Code of Federal Regulations Title 21 (21 CFR Part 11)
- ISPE – International Society for Pharmaceutical Engineering (GAMP 5)
- 2º EMA Eudralex – EU Legislation – European Commission (Annex 11)
For more information and explanations about it, send us an e-mail: [email protected]
Passarini Regulatory Affairs
Published: 07/31/2019
