News Archive 2016

FDA's draft guidance on data integrity
The importance and amount of data being generated to ensure product quality and patient safety continues to grow. Proper controls around that data is being questioned, which forces FDA to re-evaluate the industry guidance.

The industry guidance applies to all areas of pharmaceutical business and focuses on topics as: 
  • Are roles and responsibilities clearly defined in an SOP?
  • Does your company have a procedure that describes a regular review of your audit trail? 
  • Is test evidence available to show additions and changes made in the audit trail?

Need help? 

Do you have doubts on which workflows need to be validated? Or watn to know when it is permissible to exclude CGMP data from decision making? Agidens can help.

First of all, you will need to revise your current system in order to map improvements. Agidens has the expertise to help you with the analysis of your system. But we can do more: our Data Integrity Experts can also think along to improve your data management on a structural level, so that you have a future proof system in place.

By all means, do not wait until there is no way back and adjust your company's SOP as soon as possible. Read the draft guidance here.

Contact us

Via one of our local teams.


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