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Document and Records Management

The Document and Records Management document was written to give basic concept of document and records management, and to share experience of the National Competent Authorities (NCAs) in this field. 

What does this document cover?

1. Introduction

2. Documents and records management

 - Document and record

 - Document and records management – records lifecycle

 - Paper based Records Management System (RMS) versus Electronic Records Management System (ERMS)

 - Compliance with laws applying to EU

 - Record management and documentation of quality systems according to GVP module 1

 - Minimum requirements according to Commission Implementing Regulation

3. Examples

4. Summary and conclusions

5. References

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.


26 pages PDF.

Click here to access this document.

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