The Gruppo SASI’s solution, called PSMF Manager,
for the management of the Pharmacovigilance System Master File,
is developed in full compliance with the legislation in force for the
European community published on the European Medicines Agency website
(www.ema.europa.eu) whose legal requirement was introduced
by Directive 2010/84/UE amending Directive 2001/83/CE.
The product, in accordance with CFR 21 Part 11 and Annex 11, has the following characteristics, some of which are also required for validation:
- Document management of the new PSMF with automated creation of the related files in word format and association of any template
- Life Cycle management for changes to the PSMF.
- Versioning (every change made to a document is monitored and archived)
- Audit-trail (the main operations carried out by users are tracked, with the possibility of consultation by the system administrator)
- User profiling to ensure access and rights to documents
- Automatic creation of the final PSMF in PDF format with indexing of chapters and subchapters to allow an efficient navigation throughout the document and with the maintenance of any hyperlinks between the various paragraphs. In addition, if a PSMF is already present, it would be renamed according to agreed specifications and placed in a dedicated repository to be consulted at any time
- Approval process by the QPPV or its Deputy of each paragraph, modified by other users, against insertion of a Logbook notes
- Automatic management of the Logbook (Annex I1 and I2) that downstream of the first electronic version of the PSMF through the insertion of metadata with the appropriate function, automatically updates the paragraph of the logbook
- Management of the tracking of consolidated versions that allows the storage in a specific directory of files in pdf format reporting the changes occurred in the paragraphs that are part of the PSMF.