Computer System Validation

PublishTime：2022-04-18

To develop the validation methodology, the companies also have 14 normative instructions, several guides and also with the Brazilian pharmacopoeia, being made available in this way all the requirements standardized in Brazil. Computerized systems, which are any and all systems that include data entry, electronic processing and the output of information to be used for reports or automatic control, also require special attention and have specific documents for professionals to follow (RDC 301, 2019, IN43, 2019 and Guide No. 33 ANVISA, 2020).
The CSV, which is it commonly called Computer System Validation, began to have its own aspects under the perspective of Normative Instruction 43, which "Provides for Good Manufacturing Practices complementary to computerized systems used in the manufacture of Medicines" and has the objective of adopting the Guidelines of Good Manufacturing Practices related to computerized systems of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), as complementary requirements to be followed in the manufacture of medicines in addition to RDC 301 (2019). Since January 2021, ANVISA has been part of PIC/S, an international initiative to inspect good pharmaceutical practices with 54 participating members. Among the recommendations described in the guide, it mention the mandatory confirmation of the validation of computerized systems provided to be used in the various processes and with activities included in the qualification stages of validation processes (ANVISA, 2020, PIC/S, 2021).

Brand of Product：	KAYE
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Product Category：	More
Application：	[ Pharmaceutical Inspection ] More
Data Type：	White Paper More
Safety & Environment Standards：	More
Operating Temperature：	Please see the document for details
Qualification Grade：	More
Qualification Approval：	More
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Language：	English Chinese Chinese and English Japanese
Date of Creation：	29/07/2021
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Data Size：	1.1 MB

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