Complex production processes seem impossible without software in production. However, proof must be established ensuring a risk-minimized operation within QM-relevant processes (ISO 13485).We support you in identifying and evaluating the software correctly as well as in representing the processes within your quality management system appropriately.Our experts are happy to provide their help and advice for all validation activities.Contact us now!
The more complex the device, the higher the requirements of a modern production; the more networked the production, the higher the share of software. Keep control of the increasing complexity with validating your software.
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ISO 13485:2016 defines the requirements for a quality management system in which a company has to prove that it is in the position to provide medical devices and related services that fulfill the customers’ needs and comply with applicable regulations.The International Society for Pharmaceutical Engineering (ISPE) introduced the risk-based approach to validation of computerizsed systems in 2008 with the GAMP 5 guideline. The 2nd edition of GAMP 5 was published in 2022.GAMP 5 applies to computer systems used in the medical device and pharmaceutical industries. GAMP 5 explains in great detail how to carry out validation on a risk-based basis.. ISO/TR 80002:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.The AAMI TIR36: 2007 is a best practice guide for the "Validation of software for regulated processes". It applies to the same software as ISO/TR 80002-2:2017 and can also be applied to software that creates, adapts or stores electronic records and software that manages electronic signatures, provided they are subject to validation requirements.The scope of AAMI TIR36:2007 is the regulatory requirements of 21 CFR 820 (Quality System Regulation) and 21 CFR 11 (Electronic Records; Electronic Signatures).