Understand the Applicability of FDA’s Computer Software Assurance Guidance to Data Integrity

” Computer System Validation” (CSV) has actually continued to be mainly the same for the previous 2 years. General Principles of Software Validation (GPSV), provided by the FDA in 2002, has actually been and also proceeds to be the main device sector utilizes as advice on this subject.

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See for even more information regarding: https://bit.ly/3nBIJOX FDA CSV to CSA and also to Recognize the Applicability of FDA’s Computer system Software application Guarantee Assistance to Information Honesty

0:01 -09:43- FDA CSA Industry Team Introduction
09:04 -10:08- A New Approach to Validation
10:09 -11:26- CSA Objectives
11:27 -21:38- CSV for Manufacturer
21:39 -29:33- Inspection Ready Manufacturer
29:34 -38:09- GMP Data Integrity Challenges
38:10 -38:27- CSA/Data Integrity Validation Tools
38:28 -41:13- Data Integrity DI-Key Stroke
41:14 -47:15- Data Integrity Efforts
47:16 -49:09- Validation Testing
49:10 -01:00:16- Questions.
01:00:17 -01:06:40- Conclusion.

” Computer System Validation” (CSV) has actually continued to be primarily unmodified for the previous 2 years. General Principles of Software Validation (GPSV), released by the FDA in 2002, has actually been and also proceeds to be the main device market utilizes as support on this subject. FDA intends on launching their Guidance on Computer Software Assurance quickly!