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HALOPV - transforming the management of the Pharmacovigilance System Master File (PSMF)

The PSMF document is a compulsory and vital part of pharmacovigilance compliance in Europe, supporting and documenting a company’s compliance with the requirements laid down in EU legislation. Each pharma company has to have such a file, fully describing their PV system. It must be kept up to date and must be available within seven days on request if the EMA wishes to view it. As well as describing the company’s PV system, the PSMF includes annexes with up-to-date information on topics such as ongoing and completed clinical trials, registered products and audits.

The PSMF holds a large amount of important information and the variety of the information included means that all the information is rarely managed by the QPPV themselves, who maintains oversight and is responsible for the PSMF itself. The content might be provided by different personnel, from regulatory affairs, quality assurance or clinical development. Therefore, it is essential that the communication between these personnel and the QPPV is as seamless and transparent as possible.

Reducing the need for manual effort

The coordination of the material required for the PSMF used to be a highly manual endeavour. People would work with document management systems and the QPPV Office would have to manage multiple email exchanges and spreadsheets, in order to track who was providing what information and what had been sent through, then chasing what was needed. They then had to create a common format for all the information received so it could all be pulled together cohesively.


Companies are updating this information at least on a quarterly basis and the bigger the company, the bigger the headache to collate everything correctly and on time.

However, the technology used and developed for Insife’s revolutionary HALOPV system has now automated this process, saving effort, time and therefore money.

Templated for ease and consistency

The data sent through each annex is of course from different sources and systems, but HALOPV has an interface with other systems which identifies and uploads just the information that is needed, yet again eliminating excessive manual work. There are also templates for each annex so that once all the information has been uploaded from the different sources, it is all presented with the same look and feel. This makes it much easier to have a full oversight of all the content and be able to review it as needed.

All the annexes in the PSMF can be auto-scheduled, with notifications being sent out directly to the responsible person for each section of content. The system can also take away the need for ongoing manual tracking and follow up, with reminders being sent out automatically too. Based on our experience, the man hours saved can be substantial.

It all starts with implementation

The key to a successful use of the PSMF module is the detailed work undertaken at implementation. Agreeing on the annexes and who will deliver the content for each is of course essential. While the QPPV is the person responsible for the PSMF, the responsibility of maintaining it may be delegated to a member of the QPPV Office. This depends on the size of the company and its internal structure.

The structure and working practices of each company also means that certain things in the Insife system need to be adaptable. There are templated workflows within the PSMF module, but they can be configured differently to make the module work in the most efficient way for each and every client.

The other crucial part of the implementation is of course the decisions on where the data are coming from and in what format. It could be emanating from five or six different IT systems in different departments, so agreement on formatting is key at this stage.

The future - globalising the PSMF

The EU’s PSMF legislation was set in 2010 and there are moves to create similar processes globally. Already, the UK (post Brexit), Turkey, India and Saudi Arabia have implemented their own requirements and others are following. There are challenges when looking at local and regional requirements as the varying regulations undoubtedly lead to logistical challenges. Insife are jumping to this challenge by providing options to create similar solutions for other countries.


The key is to create rules that determine when the same information is required for other territories, so that replication of information is minimised and key data are shared as necessary.

HALOPV – the solution for future proofing your PSMF!

With the proven technology at the heart of HALOPV and the success of the PSMF module, Insife is in a perfect position to work with companies and regulators alike, to make the PSMF as seamless and efficient as possible, right across the globe.


Get started with Insife today

Want to know more, get a demo or take it for a test drive? We would love to answer any questions you have, take you through a demo or let you test the system so you can explore yourself. We look forward to working with you.

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