top of page
PSMF Generis
CARA Life Sciences Safety Logo copy.png

PV System Master File (PSMF)

Simplifying a complex process

PV Safety Master File (PSMF)

Managing the PSMF is a complex ongoing task, between updating sections owned by different parts of the business, and the challenge of creating the Annexes from information that comes from a variety of sources. CARA facilitates the entire process, including automatically generating the Annexes.


Breaking up the PSMF into separately owned sections

The PSMF main body chapters and annexes are separated in sections within CARA allowing the flexibility of multiple data owners. Workflows will be generated based on date triggers to the respective owners, and then finally to QPPV for review and approval

Generating the Annexes

CARA can automate retrieving of data from various systems for automatically generating submission-ready PDF documents for each annex. The source systems for the data can be CARA (e.g. SDEA), MS Excel (exports from other systems), or via direct integration with other systems. The changes within the PSMF sections themselves are recorded in the CARA Audit Trail and can automatically generate an annex documenting the updates

Quarterly and Annual Reviews

Dependent on which section would need to be reviewed quarterly or annually, there will be periodic review workflows managed through CARA, to notify the relevant section owners of the required update. Versioning will be used in CARA to produce the newly updated documents from older versions as well as keep track of previous versions


Once all relevant documents are up to date and approved, the different sections are concatenated, assembled, producing one MS Word of PDF document containing all updated sections ready for submission

Global vs. Local

The sections of the Global PSMF can be used for the Local PSMF or adapted. Through property inheritance, CARA allows an automation for the generation of local sections from global sections. Local PSMFs per country/market are also handled and stored in CARA with the same functionality as Global PSMF

Example PSMF Section Update Workflow

Quarterly or Annual Periodic Review for a PSMF section or Annex

Acknowledge receipt, update required

Update of Section or Annex

Section in Final Draft

Received, Reviewed with comments and/or Approved


minute read

Press Release : Generis and Risetime


minute read

AI for Beginners: Understanding AI Terminology


minute read

Driving Efficiency in Life Sciences Business Processes with Standardised In-Flight Data

bottom of page