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<\/p>\nEasily meet regional regulatory requirements with a modern PSMF solution that harmonizes global content, supports local annexes, and delivers QPPV oversight.<\/p>\n
More countries\/regions are adopting EU good pharmacovigilance practices (GVP) Module II,
\nhowever, how they apply the guidance varies greatly by region. This variability makes it
\nincreasingly difficult for sponsors to manage the pharmacovigilance system master file (PSMF).<\/p>\n
Modern PSMF management solutions have a modular approach that reduces complexity
\nand overhead in maintaining multiple PSMFs while facilitating regulatory learnings between
\nregions. With a single global solution, real-time content visibility, and greater efficiency
\nin PSMF production and maintenance, safety teams can deliver more timely and higher
\nquality PSMFs. They can also leverage this information to improve oversight and to drive
\nimprovements in pharmacovigilance (PV) system performance.<\/p>\n
To give regulators a strong first impression of the PV system, keep your PSMF current and
\navailable to health authorities in a timely manner. Typically, regulators will want to see the
\nPSMF within a week of their request.<\/p>\n
<\/p>\n
Market authorization holders (MAH) often manage the PSMF at the local level, leading
\nto inconsistent global processes and duplicates of similar documents. Centralizing
\nPSMF management and taking a modular approach harmonizes content across regions.
\nThis makes it easier to meet regional requirements while delivering global oversight. Modern
\nPSMF solutions provide a modifiable standard template that is organized into a global main
\nbody and annexes, with flexibility for local regulatory and PV experts to supplement the
\ncontent with local or regional data.<\/p>\n
Virtual PSMF binders bring together core content that is applicable to all markets with local
\nor regional documents and data. With one click, the safety team can generate the PSMF. Then,
\nthey can collate the core and specific regional content to create the final document for review
\nand approval before submission.<\/p>\n
Managing content for all PSMFs within one validated GxP solution simplifies the IT landscape.
\nThis:<\/p>\n
One of the biggest challenges in maintaining a PSMF is keeping content current. The PSMF
\ncontains documents owned by different functional areas across the company and partners.
\nAllowing internal or external document owners and subject matter experts to collaborate,
\nupdate content, and have it dynamically reflected in the PSMF significantly reduces the burden
\non the qualified person for pharmacovigilance (QPPV).<\/p>\n
Modern PSMF solutions have flexible security models that allow companies to provide
\nusers access to specific documents or binders and define how they can interact with them \u2013
\nincluding editing, commenting, reviewing, or approving. Teams can set reminders to ensure
\ncontent is reviewed periodically according to standard operating procedures (SOPs), and the
\nQPPV team can be notified of changes to support oversight. The QPPV can also track all events
\nin a document\u2019s history in detailed audit trails, including the name of the reviewer or approver
\nand a timestamp that can be shared with an auditor.<\/p>\n
Implementing a robust change control will keep your PSMF current and help you stay informed
\nof relevant changes and modifications recorded in the logbook. The QPPV regularly checks the
\nlogbook for changes to maintain oversight. With a manual process, it is challenging to keep
\nthe logbook up to date, spot which documents were changed, and identify who modified them.<\/p>\n
Instead, look for a PSMF solution that automatically tracks changes \u2013 including the date,
\nnature of the change, description \u2013 and updates the digital logbook. It should also be able to
\nautomatically notify the QPPV of PSMF content changes to help them demonstrate oversight
\nduring an inspection and generate a more current logbook. Always having an up-to-date
\nlogbook eliminates the manual overhead of maintaining another document and reduces
\ncompliance risk for the QPPV team.<\/p>\n
![\"\"](\"\/wp-content\/uploads\/2024\/11\/How-to-Globalize-PSMF-Management-for-Greater-Efficiency-and-Easier-Compliance2.png\")
<\/p>\n
Traditionally, producing and maintaining a PSMF is labor-intensive and manual. QPPV teams
\nspend significant time obtaining and compiling documents that must be merged into a single
\nfile for submission to a health authority.<\/p>\n
A modular PSMF approach allows safety teams to dynamically maintain content and
\nautomatically generate the file at any time. This includes the logbook for digital review by the
\nQPPV or the local person for pharmacovigilance (LPPV) before submission. Capturing the
\napproval of the final file with electronic signatures allows companies to demonstrate QPPV
\noversight in audits or inspections. With a much faster PSMF process, QPPV teams can easily
\nrespond to health authorities in a timely manner.<\/p>\n
Validating new software applications can be cumbersome and slow. It is even more
\nchallenging to maintain a validated environment within a custom solution. This may cause
\ncompanies to avoid validation altogether by delaying application upgrades.<\/p>\n
Opting for a PSMF solution designed for regulated environments will significantly reduce
\noverall validation time and effort. Cloud-based PSMF solution vendors perform and document
\nall elements of infrastructure qualification (IQ) and operational qualification (OQ) for each
\nmajor release. Sponsors can also leverage user acceptance testing (UAT) scripts and adapt
\nthem as needed for performance qualification (PQ). Reducing the validation burden allows
\neven the leanest safety teams to keep up with innovation and new regulatory requirements.<\/p>\n
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<\/p>\n
A harmonized, collaborative approach to PSMF management will lead to:<\/p>\n
One top 10 biopharma cut their cycle time from PSMF authoring to review and approval of the
\nfile by 30%. Standardized and modifiable templates with global and local content structures
\nfacilitate governance and support oversight with easy navigation and efficient review. Virtual
\nbinders enable fast generation of a specific local PSMF. \u201cPreviously, it would take me many
\nhours to publish a PSMF,\u201d said a PSMF steward at a top 20 biopharma. \u201cNow, I can produce a
\nmerged PDF that contains all of the documents in the correct formatting in 10 minutes.\u201d<\/p>\n
With digital end-to-end processes, a modern PSMF solution provides greater control and
\ncontinuously collects data to enable compliance tracking. For example, automated emails notify
\ncontent owners of reviews and updates. QPPV teams can leverage reports to track whether
\ncontent tasks are completed on time. With greater transparency, \u201cWe\u2019ll start to see much more
\nengagement from the PSMF contributors when it comes to completing their tasks,\u201d said the top
\n20 biopharma PSMF steward. Process data can support embedded analytics for the QPPV team,
\neither leveraging existing reports and dashboards or modifying and creating new ones. \u201cReports
\ngive great oversight of the PSMF. You can see what stage in the workflow documents are in,
\nor which contributors still have open tasks and reach out to them,\u201d the PSMF steward said.<\/p>\n
Cloud-based solutions are not only transforming PSMF management. They are also changing
\nhow content is managed across biopharmas and their external partners. For example, sources
\nfor PSMF documents can be owned by departments outside of safety. This causes difficulties
\nidentifying content owners and verifying that content is current. With a single cloud platform
\nacross functional areas, PV employees can associate documents in any department with a
\nPSMF \u2013 eliminating content duplication and ensuring data integrity.<\/p>\n
As companies adopt modern PSMF solutions and technologies continue to advance, the PSMF
\ncan evolve from a repository of content to an asset for enabling real-time oversight of PV
\nsystem performance. With greater operational visibility, the PSMF can drive proactive focus
\ninto key areas to improve performance and reduce inspection requests and time on site.<\/p>\n