Computer Systems Validation

A White Paper on How to Make the Software Validation Process Practical Instead of a Compliance Burden

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 requirement, but also a practice that makes good business sense.

This white paper discusses the concept of computer software validation as presented in FDA guidance documents and 21 CFR Part 11.

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White Paper Description: A Pragmatic Approach to Computer Systems Validation

This white paper, published by MasterControl, offers practical strategies for reducing overall validation time and costs. It explains the benefits of implementing a risk-based approach to computer systems validation.

Relevant and timely information contained in the white paper includes:

  • The significance of computer system validation
  • The FDA's expectations with regard to computer systems validation
  • The use of risk assessment in computer system validation
  • Potential savings that can be derived from vendor validation documentation
  • Commercial off-the-shelf solutions that can decrease computer system validation time and costs

MasterControl and Computer System Validation

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.

Computer system validation is required by FDA regulations and international quality standards, including: 21 CFR Part 11, 21 CFR Part 820, ICH Q9, ISO 13485:2016, and European Union’s Annex 11.

Contact MasterControl Today for Computer Systems Validation

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&As, case studies and webinars for regulated companies.