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recent MHRA Findings
The MHRA review of their inspection findings for 2019 shows a new (?) inspection emphasis. The findings are ranked below in order. As you can see the data integrity principles are starting to show through more in 2019:
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1 Production controls and instructions
2 Contemporaneous record keeping
3 Approved and signed off documents
4 Record keeping
5 Review of quality documents in a timely manner
6 In process controls
7 Document control
8 Management review
9 Change control
10 Design of documents
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If you have of these issues I can help you improve !
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