The white paper "A Pragmatic Approach to Computer Systems Validation" explains the function and benefits of applying a risk-based approach to computer systems validation. The paper defines risk-based computer systems validation as not only a regulatory component, but also as a practice that makes good business sense.
This white paper discusses the concept of computer software validation in relation to 21 CFR Part 11. The FDA requires computer systems validation through a development lifecycle containing strict guidelines with concept, user, and functional requirements.
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The "A Pragmatic Approach to Computer Systems Validation" white paper, provided by MasterControl, offers practical information that can lead to actual reduction in validation time and costs. The white paper explains the tangible benefits that companies subject to regulatory requirements can receive by implementing a risk-based approach to computer systems validation.
Relevant and timely information contained in the white paper includes:
Computer system validation is an important component of risk management. No software is guaranteed by its manufacturer to be perfect. The more complex the software becomes, the more likely the existence of errors becomes. It is good business sense to prove to customers that the existing computer systems do what they are intended to do both functionally and operationally. This is the basis for computer system validation.
FDA compliance is another reason for computer system validation. Computer system validation is required by the FDA as well as ISO 13485: 2003. Medical device companies must also transition to the 2003 version of 13485:2003. 21 CFR Part 11 lists a number of software systems requirements a company must follow to ensure they have trustworthy and reliable electronic records and signatures. If an organization uses electronic records and signatures but fails to follow these system requirements, the FDA will cite the firm for violating the underlying regulation.
To learn more about MasterControl, computer system validation and compliance with 21 CFR Part 11, feel free to contact a MasterControl representative or visit MasterControl’s Resource Center. The Resource Center offers industry white papers, product data sheets, Q&A’s, case studies and webinars which provide extensive information for companies seeking new tools for change management.