Have you ever written an audit finding only to get back the following response? “This is not a finding…” Most of us have at one time or another. I think we can all agree it’s not a good feeling. Here are 2 tips to help you eliminate this response. 1. The exit meeting is not… [Read More…]
Why Do UAT On Service Provider Systems?
Outsourcing services is quite common in clinical development. We outsource everything… Lab analysis of subject samples (central clinical labs) Interpretation of subject medical images (central imaging readers) Data capture at clinical sites (EDC and ePRO) Randomization and management of investigational product (IVRS/IWRS) Trial master files (eTMF) …and the list goes on and on…. [Read More…]
New FDA Q&A on Data Integrity
On 5 August, FDA published a new set of 7 questions and answers. 3 questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us: Maintain the electronic records created by instrument systems used for your GLP and GCP studies – paper printouts are not… [Read More…]
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