The Drug GMPs explicitly require signatures in the following places: 211.186 master prod & control recs 211.182 Equipment cleaning & use logs 211.188 batch prod & control recs 211.194 laboratory recs (perform & review) Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where...
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Solvay Pharmaceuticals 6/23/99 Computer System Validation 1. The xxxx computer system, used to monitor and maintain such critical systems as the xxxx and xxxx systems, has not been validated. Our inspection revealed that the xxxx computer system is used to monitor temperature, conductivity, water pressure and time (in hours) for replacement of xxxx for the...
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Multidata Systems Intl. Corp. 7/16/98 Decision Support Systems (DSS) for Radiation Support device 1. Failure of management with executive responsibility to appoint a member of management to establish authority over and responsibility for (a) ensuring that quality system requirements are effectively established and effectively maintained, and (b) reporting on the performance of the quality system...
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Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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