The retention and preservation of study records and source data, is a critical component of compliance with GxP. It is essential to preserve the accessibility, readability, integrity, and (where necessary) usability of these records throughout the entire duration of their required retention so that
- a study can be inspected and reconstructed;
- the data generated and the outcomes reported can be understood and verified; and
- evidence of patient safety can be maintained.
The requirements for archiving digital records are no different to those for physical records but the variety and complexity of digital records requires additional considerations. It is no longer acceptable to archive digital content by simply locking it and storing it: a digital archive must be continually and actively preserve digital content in order for the archived content to be compliant.
Heath Barrowcliff Consulting works with clients to
- advise on the principles, concepts, prerequisites, and supporting governance frameworks necessary for compliant digital preservation;
- provide expert insights into- and guidance on- pragmatic, good practice approaches to address digital preservation challenges, especially in relation to obsolescence, digital continuity, and data integrity; and
- facilitate and support the evaluation, procurement, and implementation of bona fide digital preservation technology solutions.