K2C PSMF Solution

K2C PSMF Solution is a modern approach to the management of Pharmacovigilance System Master File.

This document typically requires periodic updates as per significant changes in pharmacovigilance process. These changes require that multiple company roles are involved in editing of a document that is composed of paragraphs and annexes that are all time the same, because fixed by regulations.

But co-editing is complex, in addition part of content should be reserved to some editors and even not available to other contributors.

Here the magic: K2C solution allows to handle the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents.

K2C PSMF Solution includes:

• Management of PSMF Contributes (paragraphs and annexes) as distinct documents
• Management of access rights for viewing or editing of PSMF Contributes
• Management of entire lifecycle, from generation of DLP (Data Lock Point) to collaboration and approval phase
• Fully paperless approval (electronic signature)
• Version history and full traceability at different levels: PSMF document, DLP requests, contributes (source documents and annexes that compose a PSMF)
• Record retention