By its very nature, compliance with regulatory requirements is daunting.
Its whole reason for existing is to make multiple highly complex processes completely watertight so that organisations are absolutely – and demonstrably – above reproach. The reality is that of course we’re all leaking a little here and there.
As digital safeguarding experts, Arkivum have been keenly tracking the trends in pharmaceutical records and archives management methodologies. The latest MHRA GMP inspection deficiency data trend report reveals some concerning critical and major deficiencies in relation to data integrity.
- Inadequate or conflicting data retention policies
- Inability to guarantee future-proofed access to the data
- Backups not available or copied on the same devices as the primary data copy
- Inability to locate data or search across eTMFs
For consecutive years, Quality Systems – the category under which data integrity falls – remains the top inspection deficiency across the industry. In a blog post in 2015, Gail Francis, MHRA, noted “…problems with the provision of the TMF could result in the rejection of an application due to the inability to fully evaluate the compliance of the trial with GCP requirements.”
The process of moving from paper to digital trial management hasn’t become any easier for Records Managers, Archivists and IT Managers to navigate since then either. This is borne out in a 3-part series of blogs from David Churchward, who outlined the importance of the “ALCOA” principles: data should be attributable, legible (permanent), contemporaneous, original and accurate.
There’s still much to be done by pharmaceutical companies in order to adjust to the new digital paradigms. For our part, Arkivum are excited to be part of the enabling technologies underpinning this wave of changes. There is a useful White Paper called Navigating the Governance of Pharma Data: have you got the M.A.P? – in this case the ‘map’ in question is an acronym for three pillars of long-term data management:
- Metadata: being able to search for and easily find data based on how it has been described
- Archiving: knowing the data is bit-level secure and immutable for the long term
- Preservation: relying on the ability to open and read old file formats in decades’ time
For compliance with MHRA and the wide range of other regulations to which the pharmaceutical industry is subject, this approach is highly pragmatic. If the industry were able to demonstrate compliance in these 3 key areas, we anticipate the Deficiency Data Trend report in years to come would look very different.
If you would like further information, please contact our team.