GMP Guideline Manager Version 15.0 released

Recommendation

23-26 April 2024
Berlin, Germany

Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach
Learn How to Plan, Implement and Document Effectively Computer Validation Activities

The European Compliance Academy has been developing a very useful tool for 15 years now. The GMP Guideline Manager CD contains all relevant GMP Guidelines from EU/EMA, FDA, ICH, PIC/S and WHO. In addition industry guidelines from APIC (GMP interpretation for APIs) and IPEC (GMP/GDP interpretation for Excipients) are on the CD.

A team of experts from Concept Heidelberg has been entrusted by the ECA Foundation to update the guidelines on the CD and to further develop the software which enables users to easily navigate on the CD and to search for keywords. The structure is provided by two so called "trees".  The first tree is structured according to the relevant organisation. This allows users to find specific guidelines, e.g. those from FDA or those from EU/EMA. The second tree is structured according to keywords. By this users can navigate and find guidelines for a specific topic, e.g. to list all validation guides.

A comprehensive search engine allows users to search in all documents for keywords. The full text search function supports them in finding relevant information about a specific keyword within seconds.

The GMP Guideline Manager CD can not be purchased. It is a free gift to all ECA members. Every participant of an ECA event receives a complimentary copy of the CD. In addition all colleagues who aquire an annual individual membership receive a copy. Companies becoming member of the ECA Foundation receive a multi user version of the Guideline Manager Software which allows installation on a server and access for all employees of the company.

All current ECA members can access the GMP Guideline Manager online in the ECA Members Area.