Computer System Validation in the Regulatory Environments
In the modern world, with the rapid growth in technology, companies have turned to computer systems to become more productive. Like most other industries, the FDA regulated firms have also swiftly adapted the use of computer systems to increase the efficiency of individuals, reduce errors, and increase overall productivity. So it is only normal to use electronic records instead of paper records.
FDA regulated companies that maintain records or submit designated information electronically to FDA must ensure compliance for both infrastructure qualification and computer system validation.
To successfully implement, use and maintain computer systems, the regulatory, clinical, and IT professionals working in the healthcare, clinical trial, biopharmaceutical, and medical device sectors must gain relevant knowledge.
Computer systems validation compliance requirements and standards:
Applicable to records and signatures
Requires suitable features and validation
FDA’s definition of computer system validation (CSV)
Computer System validation requirements
Tasks supporting validation
Validation planning
Computer system validation activities should be documented with the following
Analyze system requirements and develop clear and precise functional requirements
Perform risk-based CSV
Attend the seminar ‘Computer System Validation - Reduce Costs and Avoid 483s’ to explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
The speaker David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications.