AQL stands for Acceptable Quality Level and is sometimes translated as “permitted reject rate.” The AQL determines when a batch of parts or products is rejected or accepted based on a random sample inspection. However, auditors regularly no longer accept the AQL. What to do? This article provides answers. 1. Who is affected by the…
DetailsIn software development, unit testing refers to the testing of software units. However, there is no common understanding of This article provides clarity. 1. Test objects: What is tested during unit testing a) Usual understanding of software units Unit testing involves testing delimited parts of a software system. Depending on the size of these parts,…
DetailsIn 21 CFR part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A lot of companies print everything out on paper and then sign it by hand to circumvent the requirements of part 11. Is this really necessary? 1. 21 CFR part 11: A source…
DetailsElectronic and digital signatures should be considered on an equal level to handwritten signatures (“wet ink”). The requirements that need to be fulfilled depend on the extent of the binding force that is to be achieved and so depend on the document that is to be signed. This article explains 1. When is a signature…
DetailsBoth IEC 62304 and the FDA require integration tests. 1. What are integration tests? Integration tests verify whether software components that use interfaces of other components, i. e. call its methods, properly handle their returns (return values, exceptions). 2. Why are integration tests necessary? a) Improve the quality of the software Integration tests, like all…
DetailsWe frequently get asked, “Do you also offer Computerized Systems Validation?” One of the reasons for the interest is certainly: Authorities and notified bodies increasingly address the Computerized Systems Validation (CSV) in audits. This article introduces regulatory requirements regarding “Computerized Systems Validation” and provides guidance on how you can best meet these requirements. Computerized Systems…
DetailsProcess validation is the verification that a process meets the requirements imposed on its process results. Learn when you must validate which processes (in the context of software) and how to ace validation. Furthermore, find out what process validation has to do with PQ, IQ, and OQ. Process validation: What is it exactly? a) Definition…
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