Long-term storage of trial master files (TMF).
Recent changes to the European Medicines Agency’s (EMA) guidance require that Trial Master File (TMF) data is kept in an accessible and readable format for a minimum period of 25 years. As such, all pharmaceutical companies have a regulatory requirement for the long-term storage of data.
Whilst there remains the argument that paper records storage is the simplest way to meet this regulation, the recent trend towards electronic trial master files (eTMF) creates a necessity for robust, long-term data management solutions.
How can you ensure future apps will be able to read the data files of today?
Ardington Archives partnered with Arkivum to offer a complete solution to the storage of trial master file data, whether it be electronic or physical documents. The Arkivum electronic solution provides a clear, auditable, and secure cloud-based preservation tool, supporting records and archiving staff within pharma and life sciences to follow best practice guidance.
Key features include:
- Trial master file data (TMF) can be stored in multiple locations by one solution to protect against data loss
- Regular automated checks of each file to quickly identify issues of data corruption
- Audit logs can track who has accessed the files and when
- File normalisation will overcome file format obsolescence, by maintaining an up-to-date version of your file, no matter how often formats change
- Secure access can be provided to the right documents when an inspector needs them, no matter how long after marketing approval.
This meets the requirements that data needs to be both accessible and readable for regulatory audit purposes, whilst ensuring data integrity remains complete and reliable, just in case there are any questions about products or trial processes in the future.
But what if an original document is paper-based?
Traditional methods of storage, meeting GxP guidance, remain a valid solution. Temperature and humidity-controlled storage environments increase the long-term integrity of paper documents, whilst access control of these environments provides a high level of security. Although original physical documents can be digitised and are accepted by some regulators if a robust validation process is provided, any original document created electronically must be maintained in its electronic format and it is not permissible to print a copy of this data for archival purposes.
To conclude, as the clinical trial process looks to embrace a growing number of technologies, sponsors and CROs need to find smarter ways in which to manage their data. This includes ensuring that effective preservation and archiving strategy is in place, whether that be physical or electronic.
Ardington Archives LLP is on hand to discuss the most suitable solution for your company archiving. Offering a range of physical storage environments, Arkivum’s bespoke electronic storage system, or a hybrid solution of both, our aim is to provide you with the most advantageous and cost-effective storage management solution meeting regulatory compliance.