Brief:
In any pharmaceutical organization compliance of 21 CFR part 11 is very important and basic requirements of FDA.
21 Code For Federal Regulations Part 11 is a law that ensures organization implement good practices. Part 11 allows a company to implement computer systems that will highly increase th e efficiency of individuals, minimize the errors by identifying risks, and increase overall productivity of the organization.
The Code of Federal Regulations (CFR) contains the laws for each of the government agencies. Each title of the CFR addresses a different regulated area. Laws typically refer to records and approval signatures, which originally referred to paper documents and handwritten signatures. Part 11 allows any paper record to be replaced by an electronic record, and allows any handwritten signature to be replaced with an electronic signature.
While Part 11 is an essential and very successful law, there has been much controversy and misunderstanding about it. The law is less than three pages long and doesn't give much detail about electronic records and signatures. Don't be mislead by the almost 30 pages of preamble material that is not the law. Just go to the end of the Part 11 document and flip back three pages to the beginning of the law. Adding to the confusion is the rapid evolution of computer technology that has made 21 CFR Part 11 compliance a moving target.
The Code of Federal Regulations (CFR) contains the laws for each of the government agencies. Each title of the CFR addresses a different regulated area. Laws typically refer to records and approval signatures, which originally referred to paper documents and handwritten signatures. Part 11 allows any paper record to be replaced by an electronic record, and allows any handwritten signature to be replaced with an electronic signature.
While Part 11 is an essential and very successful law, there has been much controversy and misunderstanding about it. The law is less than three pages long and doesn't give much detail about electronic records and signatures. Don't be mislead by the almost 30 pages of preamble material that is not the law. Just go to the end of the Part 11 document and flip back three pages to the beginning of the law. Adding to the confusion is the rapid evolution of computer technology that has made 21 CFR Part 11 compliance a moving target.
According to both American FDA and UK MHRA, computer system validation is defined as
“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”
Validation of computer systems is not a onetime event it periodic activity.
Purpose of CSV:
The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product (control information or data) which meets predetermined specifications and quality attributes.
Need of CSV:
FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.
Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.
Chalange test:
All positive as well negative challenge test should be performed at the time of installation and this should comply to it's Pre-approved acceptance criteria.
Chalange test:
All positive as well negative challenge test should be performed at the time of installation and this should comply to it's Pre-approved acceptance criteria.
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