5 challenges in assembling a Pharmacovigilance System Master File (PSMF)

psmfManaging the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge for many life-science companies. But what digital tools do you need to ensure your file is always compliant and audit-ready?

What's in the PSMF? 

The PSMF is a detailed description of the pharmacovigilance (PV) system used by a Marketing Authorisation Holder (MAH) to ensure the ongoing safety of one or more authorised medicinal products. 

  • The PSMF provides a comprehensive overview of all pharmacovigilance activities performed by the MAH to ensure the safety of its products. 
  • The PSMF is a requirement of the EU Directive 2010/84/EU. 
  • The PSMF includes information on the MAH's organisation, pharmacovigilance standard operating procedures, safety data management, quality systems, and more. 
  • The MAH is responsible for establishing and maintaining the PSMF and registering its location with the competent authorities. 
  • The PSMF must be permanently available for inspection by competent authorities and can be requested at any time. 
  • When requested, an up-to-date version of the PSMF must be available to inspect within 7 days.

It will come as no surprise to those who have to compile and curate this information that many companies struggle with the size and complexity of the task. 

The scale of the PSMF challenge for life science companies 

Life science companies compiling their PSMF need to collate potentially hundreds of documents from multiple stakeholders, drives and systems prior to submission. And their file always need to be ready for inspection on demand.  

In the past this may have been a difficult undertaking, but as the complexity of projects has increased, so the compilation and maintenance of the PSMF has become much more demanding. 

With global opportunities for pharma companies opening up and the advent of accelerated drug discovery through AI, the need to start automating and accelerating compliance processes is growing.  

What is entailed in compiling and maintaining a PSMF? 

Beyond defining the exact contents of the file, companies need to collect, review and collate all the required documents from different departments, ready to publish in an organised and structured way for internal and external audit.

After that, they will need to formally review and republish their PSMF on a quarterly basis (and on request from the regulator). These updates should reflect any organisational and procedural changes that have occurred while ensuring the nature of the change is recorded in a complete audit trail.

Not only this, but they may also be maintaining multiple versions of the same PSMF (with some variations) for compliance in different regions.

How are companies tackling this process?

Despite these complexities many companies are still attempting to control and accelerate their document-handling process through a combination of email and file-sharing apps such as One Drive, Google Docs, DropBox or SharePoint.

Here are just some of the challenges that companies can face as they try to assemble a PSMF file using typical file-sharing solutions - and why they should consider investing in dedicated document control systems, instead.

1. Data Management and integrity

A comprehensive PSMF requires the integration of vast amounts of information from various sources, including clinical trials, post-marketing surveillance, and other compliance data.

Ensuring the integrity and confidentiality of this data while maintaining controlled access for authorised users can be a huge logistical and technical challenge for those using basic file-sharing tools.

Using the right dedicated document control software can help you consistently impose the principles of ALCOA+ across your record-keeping, so that auditors can have full confidence in the provenance and security of all the PV data you assemble.

2. Stakeholder coordination

Creating a PSMF is not a one-person job — it requires coordinated efforts across various departments including commercial, clinical safety, regulatory affairs, and IT teams. Often, different teams have different priorities and timelines, making it difficult to synchronise efforts and ensure that everyone contributes the necessary data and insights on time and in the required format.

It's hard to create the kind of compliance workflows necessary to keep required documents moving through your system using platforms like One Drive. You need the tools to build bespoke approval and validation sequences to reduce the risk of errors and omissions in your PV routines.

You need the tools to request documentation from key stakeholders in your organisation, so your QPPV (Qualified Person Responsible for Pharmacovigilance)  has complete oversight and control over its contents as it is assembled.

With automated reminders to nudge stakeholders to submit and review documentation, plus templated file structures where you can quickly see missing or unapproved documentation -  you will be much more capable of co-ordinating this complex process without getting lost in a sea of documents and emails.

3. Version and change control

But A PSMF is not a static document.  Once in place, its component parts will change over time – and your file needs to reflect this.  You will need the tools to request new and updated documents from different parts of the organisation so the file remains complete and accurate.

To this end you should also ensure that proper approval sequences are defined for deviation management, with corrective action procedures in place for documented change management.

As key personnel changes and your SOPs evolve, so the relevant documents in your PMSF must be updated with details of their change history, so that auditors can see and understand your decision-making processes.

To help with this, choose a document control platform that will clearly indicate what is the latest and approved version of every document in the PMSF, while giving you access to each individual audit history. This will ensure all the details and authors of every single change are recorded with a date and time stamp.

4. Managing multiple versions of the same PSMF

With PSMF now a requirement for different regulatory regimes around the world  

companies are also having to keep several versions of the same file (with variations of appendices ) organised and up-to-date in the system for separate audits.

The right document management will help you manage this proliferation of documentation with ease, publishing the same documents as different submissions, while allowing you to customise each one with region-specific documentation.

5. Making the PSMF accessible for audit

A PSMF is required to be in place at the time of submission of all new marketing applications. It must also be permanently available for inspection by competent authorities within seven days of their request.

In her blog on PSMF management, Vanessa Fachada Oliveira, Pharmacovigilance Manager & EU QPPV at Arriello, points out that something as simple as poor formatting or omitting an index to allow easy navigation, can result in a ‘finding’ that must be corrected.

Digitising and automating the publication of your PSMF in a single document control system, is an important step in creating a streamlined compliance possess for your organisation.

The right document control system will come with advanced metadata capabilities, making it easy to pull together and publish all the required components of the PSMF, such as the summary, list of standard operating procedures, safety data, and other key elements.

If you choose the tools that can help you collate and curate documentation in a structured way, you can always see what information is unapproved or missing – helping you avoid nasty, last minute surprises and scrambles for data.

Your document control system should help you present a complete and searchable digital version of your PSMF for your auditors on demand.

It should help you:

  • Organise and index all the required PSMF contents for all marketed product in each region.
  • Ring-fence each PSMF report and give auditors password-protected access for the required time.

With some systems, when all the separate documentation is in place for each product, you can publish them all together in the required order as a ‘compound PDF’ – creating a single reference document with cover page, contents, index and annexes ready for publication and printing. 


We have just listed a few of the challenges involved in maintaining a PSMF.

But choosing the right document control software can help you de-risk much of the process and de-stress your audit experience.

There are many ‘one size fits all’ PSMF solutions in the market that can cost huge amounts of money and take months to implement. But there are also Leaner options that can help you structure, organise and publish your documentation in ways that make sense for your company.

For many companies, the pressure to digitise and automate your PSMF process is mounting, but it doesn’t have to be as disruptive and costly as you might fear.

Document control for medical device developers

Tags: GxP, Compliance, FDA Compliance

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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