What is Authoritative Guidance and how does it fit into your compliance documentation?
Compliance Documentation Components:
Authoritative Guidance is comprised of Federal and State laws, statues, regulations, and other documentation, which sets compliance standards for pharmaceutical manufacturers. Corporate policies and procedures should reflect the standards set forth with in Authoritative Guidance.
Authoritative Guidance should serve as the basis for your organization's Corporate Policies and Procedures. Essentially, the Corporate Policies and Procedures reflect the organization's most fundamental philosophical business principles.
The Business Function Policies and Procedures serve as operational guidelines. These policies and procedures provide context and detail to the more generalized Corporate Policies and Procedures. The Business Function Policies and Procedures answer the question: "How will we comply?"
