Validation FAQ (Frequently Asked Questions about Validation)

Q: When do I need to validate my systems?
A: Validation is required when your system (computer system, equipment, process, or method) is used in a GxP process or used to make decisions about the quality of the product. In addition, if the system is used to generate information for submissions to regulatory bodies like the FDA, the system needs to be validated.

Q: How does validation add value to my system?
Validation adds value to systems by demonstrating that the system will perform as expected. Validation also removes the risk of regulatory non-compliance.

Q: Do I need to validate my computer system?
A: Computer system validation is required for systems used to store electronic records, according to FDA 21 CFR Part 11.10(a) and Annex 11 Paragraph 4.

Q: Where do I find the rules for validating pharmaceutical manufacturing processes and equipment?
A: Guidelines for validation for pharmaceutical manufacturing are in FDA 21 CFR 211.

Q: What federal rules are in place regulating Quality Systems?
A: Quality System regulation is located in FDA 21 CFR 820.

Q: Why are there so many documents?
A: Proper documentation is required to demonstrate that the system was tested, including validation planning, protocol execution, and quality review. From a regulatory auditor’s point of view, if you don’t document what you did, you didn’t do it.

Q: Am I allowed to change a validated system?
A: Changing validated systems requires Change Control to ensure that there are no unexpected or unrecorded changes to the system.

Q: What is GAMP?
A: GAMP is an acronym for Good Automated Manufacturing Practices. GAMP contains a collection of industry best practices for validation.

Q: What is ICH?
A: ICH is an acronym for the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH is a collaboration of regulatory authorities from the United States, Europe, Japan, and members of the pharmaceutical industry. ICH also issues industry best practices for validation.

Q: Can you tell me if my systems need to be validated?
A: Yes. Ofni Systems performs compliance assessments, or we can train your staff to do your own gap analysis.

Q: Do you do validations?
Yes. Ofni Systems is an industry-recognized leader in computer validation.

Q: Do you have tools to facilitate our validation process?
A: Yes. The FastVal Validation Document Generator can improve the quality of your validation documentation and help you complete validation projects in 70% less time than traditional validation methods.

Validation Document Resources