Large pharmaceutical companies are often restricted by a lack of ability to exchange information and access data from other departments. PSMF is a good example of this as each of the 26 chapters requires information and input from areas across the Quality, Safety, and Regulatory domains. Despite this many organisations still use manual processes and tools like Microsoft Word or Excel to maintain and track PSMF, exposing them to non-compliance, inefficiency and delays.
Here are 5 ways in which management of PSMF can become easier with a unified platform for Life Sciences processes.
1. Know the Version
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. Version control not only allows you to see what the correct version was at any point in the document lifecycle, but also revert to previous versions when needed, and provides the ability to quickly pull up the most up-to-date version for audits, inspections, and regulatory submissions.
2. Divide and conquer – Granularity matters
The PSMF as a process, does not operate in a vacuum, and often the supporting information is needed elsewhere in your company for PSURs or a PSMF for another product for example. With a data-first platform, the content of the PSMF can be separated in to 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. Simple tagging, searching, and filtering make it easy to retrieve content from the PSMF as a whole without wasting time going through folders file by file.
3. Track your risks
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 such as the CARA Life Sciences Platform has security and compliance at its core, allowing for controlled access and granular user permissions; so users can only access the information or key parts of the PSMF that they need to do their work.
4. Submit and go
The CARA Life Sciences Platform provides a single, centralised system to streamline the organisation and submission of the eCTD. Metadata makes it easy to create and pull together all the required components of the eCTD, such as the PSMF, with the ability to add cover pages and other finishing touches ready to submit to regulatory authorities. Storing the information as components means that dossiers and submissions can be easily assembled and re-assembled as per the requirements of different regulatory authorities. Automations can ensure that submissions are not open to human error and reduce the stress of the risk of non-compliance.
5. Don’t lose oversight!
A data-driven platform provides you with a crystal clear, 360-degree view of the entire organisation’s content and information, and the relationships between them. With a single, structured information lake, features such as ‘where used’ on the CARA Life Sciences Platform make traceability and impact analysis simple. With metadata relationships between different objects, you can easily see where a change to one content item would impact items like the PSMF further down the line, all at the click of a button. Users should be able to easily access reporting and dashboards so that they can clearly visualise their processes.
The CARA Life Sciences Platform removes the technological, operational and financial drawbacks of a network of individual systems – instead, users can consolidate their processes, data and content onto a single platform of best of breed apps for Regulatory, Quality, Safety, and Clinical operations. Users can create, locate, and re-use information instantly in any process across the organisation thanks to the single Structured Information Lake, leading to accelerated work with greater accuracy of information.
Generis is dedicated to helping organisations move forward with modern, innovative solutions to make day-to-day work easier. For more than 20 years we have been supporting our customers to identify and adopt relevant new concepts, enabling organisations large and small to generate high value while delivering on the required compliance.
If you’re interested in learning more about how the CARA Life Sciences Platform can connect your end-to-end processes, or to request a demo, get in touch today at info@generiscorp.com
How does PSMF fit into your wider goals and strategy for improving your entire R&D process? Join us on 7th June for a webinar and learn how you can manage your information in a better way. Register here.