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Requirements for 21 CFR Part 11 Electronic Records and Electronic Signatures.
The questions about 21 CFR Part 11 comes up almost daily when doing computer system validation and software validation: “What is 21 CFR Part 11?” “Does 21 CFR 11 apply?” “What about CFR 21 Part 11?” etc So over the next few weeks; we are going to do a series of articles explaining this topic. […]
Stakeholder Management: Engaging the Boss
In the previous article, we explained the importance of speaking the same language as the boss and making sure that your project fulfills its expectations. However, being able to speak the boss’s language and being aware of where your project fits into the overall strategy, may not be enough to establish a successful, professional relationship […]