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Writing Non-Conformance and Deviation Reports

Designed to help your investigators write clear concise reports

Everyone in the pharma industry knows the importance of thorough and well-written reports on deviations and customer complaints.  These reports are critical to maintaining and improving Good Manufacturing Practices.  And the FDA, the EMA, -- and all the local health authorities – expect you to conduct thorough investigations. They are a critical business process.

But if the records are poorly written and unclear, and readers have a hard time figuring out what actually happened, what caused the problem, and what has to be done to fix the problem – well, your investigation documents are not working.


How we can help

Over the last decade, Communication Partners has read hundreds of deviation and complaint reports from companies throughout the industry, and trained more than a thousand industry professionals.  We’ve seen where reports and records work – and where they don’t. 

Here’s how we can help:

  • Customized workshops – We can deliver a customized workshop for your organization on how to write quality deviation and complaint reports. We use your documents and records to design this workshop, and address issues such as how to:

    • describe the event concisely

    • address scope in a focused manner

    • write a thorough yet concise impact analysis for product/process/patient safety

    • formulate a clear root cause, an actionable CAPA, and an insightful effectiveness verification.

  • Useful templates and model reports – We’ve  developed report templates and model reports for a number of clients, and can help you create ones that meet your needs.  Working with your quality team, we also provide writing guidance and can draft standard text.

  • Consulting at the Point of Need – Do you have a critical deviation that you know the regulators will want to see?  Do you have colleagues that can use help on particular investigation?  We can help with remote consulting sessions, or come to your facility and review reports face to face.

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