Data Integrity Policies and Procedures
A robust framework of Policies, Procedures, Work Instructions, Templates, and Forms ensures that data integrity is “built-in” from the start.
The prospect of an audit can be intimidating and the consequences of a bad audit can have a significant impact on the future of your business.
Our experienced data integrity consultants can have your QMS framework ready in weeks!
Policy and Procedure Development
Instead of staring with a blank page, we leverage a pre-built site of SOPs, Templates, and Forms which fully encompass the data integrity requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.
Here are the steps we take:
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Meet with you to discuss what makes your organization unique, e.g.,
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Industry-specific regulations, e.g., AOPO, CAP, COLA
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Organization structure, roles, and responsibilities
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Computer systems and tools already in use for records and approvals
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Tailor our standard suite of documents to fit your organization
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Solicit your feedback on the preliminary suite of documents and make adaptations before finalizing the content.
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Develop a Quality Manual to summarize the Policy and Procedure framework and provide an overview for employees, auditors, and inspectors.