Life Sciences organizations face many challenges when tracking all of the communication that takes place between themselves and other external organizations and health authorities that they deal with on a regular basis. An essential part of any complete Regulatory Information Management (RIM) platform is the ability to plan and track all regulatory activities that an organization needs to undertake. These activities are often initiated by a request that is sent from a health authority for more information, and it is critical that these requests are traceable alongside the tracked regulatory activities in the RIM platform.
Can you keep track?
Information and requests are shared in various formats, by various means and from various locations, so keeping track of all this correspondence is a huge burden on time and resources across the organization. Manual processes are typically deployed despite any miscommunication leading to delays in activities, and even fines for missed deadlines.
Central repositories and systems to track correspondence have become essential elements of the information flow within and outside of life sciences organizations. When information is received from a health authority or external partner (such as a CRO) it needs to be:
- Processed to uncover what type of correspondence it is.
- Converted into a consumable format based on the type of correspondence and who the consumers/responsible parties will be.
- Stored in the appropriate repositories for the type of correspondence it is.
- Distributed to the appropriate individuals.
Once this has been accomplished, an entry needs to be made in a correspondence tracking system. The company-critical content can then easily be found in the future alongside other information relating to the new regulatory activity. Correspondence is often a catalyst for some form of regulatory activity (such as creating a new submission to provide more information to a health authority for a particular drug), so being able to trace the activity from the initial request provides a fuller picture of the entire regulatory history of a product.
Currently the initial steps in the processes for any correspondence tracking are performed completely manually. Individuals involved are required to:
- Monitor incoming emails to identify incoming correspondence that relates to ongoing or future regulatory activities. Examples of this might be letters of approval, requests for more information, etc.
- Convert the identified emails and any attachments (supporting information in many different formats) identified into a useful, future proof and standard format (such as PDF).
- Store the email and converted attachments in an appropriate location of a central repository (such as an electronic Document Management System).
- Create entries in the correspondence tracking system (if it exists, and if not in a tracking spreadsheet) to monitor the information received and any activities that are required to be completed due to the request.
Time to reduce risks
The risks associated with keeping track of what needs to be accomplished following such requests can be reduced. By automation and simplification.
DocShifter can help streamline the process and reduce the risks associated with correspondence tracking by automatically:
- Monitoring email systems (or specific folders or other content storage repositories) for correspondence that needs to be processed.
- Transforming the correspondence into a consumable format (such as fully compliant industry standard PDF) along with any attachments to the email.
- Storing the transformed content and/or original correspondence into whichever repositories are necessary for the type of information discovered.
- Emailing individuals with the content or to alert them of the arrival of the correspondence.
- Kicking off a task through the DocShifter API to start the entries in the correspondence tracking system.
Whether a true correspondence tracking system or spreadsheets alone are used for this purpose, DocShifter can be an integral part of this mission critical process.
The historic pain points of correspondence tracking can be drastically reduced. Arrange a discussion with us to discover how we can help. Or in the meantime, read more about the correspondence tracking solution here.