Software Validation: Answers to Frequently Asked Questions
Question: How is change control used to keep software validated?
Answer: It is normal that any system needs to be changed over time because of changes in business needs and software updates. The objective is to make sure that those changes are described properly, that the impact and risk of that change is well understood, and that there is documentation to support that assessment of the impact and the risk. A determination is then made regarding the degree of testing or revalidation work that would be required to re-establish that the system is still behaving according to its intended use in the process where it’s going to be used.
Understanding FDA Recommendations for N-Nitrosamine Impurity Levels
April 17th 2025We spoke with Josh Hoerner, general manager of Purisys, which specializes in a small volume custom synthesis and specialized controlled substance manufacturing, to gain his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.
