PSMF Automation
PSMF Automation
- August 22, 2023
- Posted by: Manoj Swaminathan
Imagine a situation where a relatively unknown country wants you to submit a PSMF within 24 hours, and you achieve this with a click of a button! Doesn’t that sound fascinating? Unfortunately, it is not that easy! Companies find end-to-end PSMF automation a tricky exercise, although it is not impossible. Besides, one must remember that PSMF non-compliance is one of the most common observations during a Pharmacovigilance inspection. Also, PSMF is the first document requested before the Safety Inspection. The agency may provide as little as seven calendar days to submit this bulky document.
An end-to-end PSMF automation would require the Integration of all the following systems:
- Quality Management System – Deviations, Audit plan, change controls, corrective and preventative actions, safety procedures, etc.
- Document Management System – SDEA, RMP, PSUR, etc.
- SAP – Product list, etc.
- Human Resource Management System – QPPV, LSO, backup personnel, contact details,
- Regulatory Management System – Safety Variations, RSI and labelling compliance, etc.
- Safety Database – Timeline and quality compliance, etc.
- IT management system – Other allied safety systems, versioning, validation status, etc.
Advantages of PSMF Automation
- Real-time PSMF – Up-to-date information at all times
- Increased transparency due to accurate logbook – Track the minutest of the changes
- Change control – Accurate change management; a change control is documented as and when there is an update
- Management oversight – identify gaps in the pharmacovigilance system, audit and inspection readiness, quick integration following M&A
- Favourable outcomes during audits and inspections – Early identification of gaps followed by resolution; improved PSMF compliance
- Saves review time – Makes life easy for the QPPV and the PSMF reviewer
- Specificity of data – Depending on the products in the respective territory
Key Risks
- Non-availability of correct information in the company systems
- Delay in the availability of data from cross-functional stakeholders
- Error in validation
- IT issues, including the unforeseen ones
- Change in regulatory requirements
That said, PSMF Automation is not that difficult to achieve. The only challenge is with the integration of multiple systems. If all the systems are developed by the same company, then it may be a simpler exercise.
Leave a Reply Cancel reply
You must be logged in to post a comment.
This site uses Akismet to reduce spam. Learn how your comment data is processed.