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Business Intelligence Solutions provides regulatory compliance, validation and information technology services to FDA regulated industries and healtcare organizations. 

Careful choice of a service provider is the essential first step to ensure high quality services. A reliable partnership will help you manage security, risk and compliance in a  clear comprehensive and transparent way to help you achieve reliable results.

Validation Documentation Requirements

Documentation is important to demonstrate system validation. The documentation should include a written design of what the system is intended to do and how it will do it.

Process Validation is a legal requirement and enforceable under the following guidelines: 501(a)(2)(b) of FD&C Act and cGMP guidance –ICH Q7 and ISO 13485.

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In essence, 21 CFR Part 11 addresses how any electronic data and associated records generated within the regulated environment are to be properly stored, secured, archived, validated and maintained. 21 CFR Part 11 directly applies to all FDA’s regulated segments, with GLP and GMP, and has hence been enforced by regulatory centers such as CDER and CBER.

A written validation or test plan should be developed to include structural and functional analysis.                                   

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