PV System Master File (PSMF)
Simplifying a complex process
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.
Benefits
Divide & Conquer – Separate the PSMF into Compartments
The PSMF main body chapters and annexes are separated into individual compartments within CARA, allowing for the flexibility of multiple data owners. Users can extract individual compartments from the PSMF for use as standalone documents, or for use in other items in the product development lifecycle. Workflows will be generated based on date triggers to the respective owners, and then finally to QPPV for review and approval.
Automated Annex Generation
CARA can automate the retrieval of data from various systems to automatically generate 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 direct integration with other systems. Any 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
CARA manages periodic review workflows for sections of the PSMF that need reviewing quarterly or annually, and notifies relevant section owners of the required update. Versioning is used in CARA to produce the newly updated documents from older versions as well as to keep track of previous versions.
Concatenation
Once all relevant documents are up to date and approved, the different sections are concatenated and assembled, producing one MS Word or 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 a Global PSMF.
Divide & Conquer – Separate the PSMF into Compartments
Automated Annex Generation
The PSMF main body chapters and annexes are separated into individual compartments within CARA, allowing for the flexibility of multiple data owners. Users can extract individual compartments from the PSMF for use as standalone documents, or for use in other items in the product development lifecycle. Workflows will be generated based on date triggers to the respective owners, and then finally to QPPV for review and approval.
CARA can automate the retrieval of data from various systems to automatically generate 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 direct integration with other systems. Any 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
Concatenation
CARA manages periodic review workflows for sections of the PSMF that need reviewing quarterly or annually, and notifies relevant section owners of the required update. Versioning is used in CARA to produce the newly updated documents from older versions as well as to keep track of previous versions.
Once all relevant documents are up to date and approved, the different sections are concatenated and assembled, producing one MS Word or 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 a Global PSMF.
Latest Resources
True Connectivity: The Lifecycle of a Drug in the CARA Life Sciences Platform
With today’s need for speed and efficiency in the life sciences industry, Regulatory Affairs, Pharmacovigilance, Clinical Research, and Quality Management cannot operate as independent islands
Barry – The Story of a Drug in CARA Life Sciences
Gone are the days when Regulatory Affairs, Pharmacovigilance, Clinical Research, and Quality Management could operate as independent islands within a pharmaceutical organisation. With todays need
Digital Mailroom on the CARA Life Sciences Platform
Consolidate physical mail and email with the CARA Platform. Our Digital Mailroom provides a comprehensive solution for adding workflows, out of office features, and delegating
