Digitising Pharmacovigilance System Master File Management

As well as exposing companies to non-compliance, inefficiency and delays, a manually-maintained pharmacovigilance system master file (PSMF) limits visibility and transparency. Christian Schmitz-Moormann, a senior consultant and pharmacovigilance (PV) expert, and partner of Generis, outlines the many benefits of fluid digital data interchange between systems.

Large pharmaceutical companies are often restricted by a lack of ability to exchange information and access data from other departments. Prompted by regulatory changes, they have largely transformed marketing authorisation (eCTD) submissions and pharmacovigilance (PV) reporting, so now the attention is turning to the management of the Pharmacovigilance System Master File (PSMF). That’s because of its bearing on so many other aspects of research and development, wider product lifecycle management, and associated information management and reporting.

The PSMF is a core document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorised medicinal products. Bringing its management and data exchange capabilities up to scratch digitally makes sense now, given that its contents are so comprehensive and wide-reaching.

PSMF management challenges

The PSMF’s numerous sections and appendix require information and input from areas across the Quality, Safety, and Regulatory domains. Despite this, many organisations still use manual processes and tools such as Microsoft Word or Excel to maintain and track the master file.

Part of the challenge around PSMF management is that so many different people are involved in providing contributory information. The file needs to be handy at all times, too –in a single, definitive location, and suppliable to an authority in the defined structure (also printable, or in an acceptable electronic format) within one week of a request being made, in the EU at least.

Although companies do have the option to lean on an external service provider to maintain and update the PSMF, the price tag for this can be hefty – running into the low six-digit range in the case of a very large pharma organisation with a great number of products, for each fresh version that is needed (not including the annual maintenance cost).

The alternative approach is to ‘divide and conquer’, allowing approved, live information to be pulled from individual, relevant departmental systems, and extracted and put together to form a comprehensive and accurate PSMF. This can be achieved with by integrating a PSMF management capability with existing functional systems across the pharma organisation, or by implementing a single open platform where all of the master information resides, already supporting any necessary integration and formatting standards.

Keeping packaging and PILs up to date

The impact of more fluid data interchange between systems, drawing on a common information core, would be widely felt.

Take the example of manufacturing and packaging, and the need to ensure that patient information leaflets reflect the current Summary of Product Characteristic (SmPC) – which outlines important information about medicines such as form, clinical parameters and pharmacological properties – plus the correct latest version of artwork. Ensuring that all of this up-to-date detail is reflected in the PSMF is crucial for all manufacturers.

Processes such as change control and deviation management also become much easier to manage once variations and deviations can simply be tagged for automatic inclusion in PSMF, as appropriate.

Improving business processes

Beyond compliance, the benefits of more dynamic PSMF creation and management, via shared and connected data, are to do with improved collaboration and communication across a national or international business group, keeping all teams singing from the same hymn sheet.

The better the state of the PSMF, the more powerful the lever to improve business processes. Strategically, that could include identification of PV risks or using the PSMF as a complete planning and tracking tool for the company’s approach to PV.

Recommendations for optimum PSMF management

With all of this in mind, here are five specific ways a unified platform can ease the management of the PSMF, with knock-on benefits across and beyond the enterprise:

  1. Version certainty

Using manual processes to collaborate and contribute to PSMF makes it difficult to maintain a single source of truth and know which version is current. With real-time collaboration and version control, you can be certain that you are working on the most up-to-date version, and any changes made are tracked on the master copy.

  1. Granularity in documentation presentation & access

The PSMF as a process does not operate in a vacuum, and often the supporting information is needed elsewhere in the company – for periodic safety update reports (PSURs), or a PSMF for another product for example.

With a data-first platform, the content of the PSMF can be separated into compartments, 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, the compartments can either be presented as a “PSMF document view” or any other view, individually or in groups, giving the flexibility to use the same single data elements in multiple document views.

  1. Risk tracking

Risk management plans and associated documents need to be created and distributed to Affiliates, Distributors and Authorities. Traditionally those tools involve external systems for sharing content and a separate system for registering and reporting on implementation status. This can leave companies exposed to non-compliance if the process is not managed properly.

A platform designed specifically for pharma companies is likely to have security and compliance at its core, allowing for controlled access and granular user permissions. This means that users can only access the information or key parts of the PSMF that they need to do their work.

  1. ‘Submit & go’

A single, centralised system can also help streamline the organisation and submission of the eCTD, during marketing authorisation applications.

Metadata makes it easy to create and pull together all the required components of the eCTD, such as the PSMF summary, with the ability to add cover pages and other finishing touches ready to submit to regulatory authorities.

  1. 360-degree oversight

Last but not least, a data-driven platform should provide a clear, 360-degree view of an entire organisation’s content and information, and the relationships between them. With a single, structured information ‘lake’ that all linked apps can draw on, features such as ‘where used’ will make traceability and impact analysis simple. With metadata relationships between different objects, it becomes easy to see where a change to one content item would impact items like the PSMF further down the line, for instance – all at the click of a button.

After eCTD and pharmacovigilance system optimisation, PSMF digital process transformation should be the focus, to drive more effective and consolidated processes, data and content that will support optimum business and patient outcomes.


About the author

Christian Schmitz-Moormann is a senior consultant and pharmacovigilance (PV) expert with over 30 years of experience in services, training and change consultancy, including an impressive history of senior roles in Safety and Quality at Life Sciences companies such as Merck and Boehringer Ingelheim. He is a strategic partner of Generis, providing specialist expertise around Life Sciences PV case management and other aspects of safety management. Generis is the creator of CARA™, a data and content management platform that helps companies in regulated industries transform their complex business processes. Generis is dedicated to helping organisations in Life Sciences and other safety-critical sectors move forward with modern, innovative solutions to make day-to-day work easier. Its CARA Life Sciences Platform streamlines the management of business processes, data, and content across the entire Life Sciences product development lifecycle. https://www.generiscorp.com/

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