For all the effort and expense pharma firms have been ploughing into regulatory compliance and associated information management, the ability to demonstrate data quality and data integrity seems to have been overlooked in many cases. And it’s a problem that needs to be addressed. Increasingly, regulatory investigators and auditors are scrutinising exactly these capabilities. Companies may have invested in state-of-the-art regulatory information management systems and sophisticated compliance-related processes, but if they can’t monitor, record and show how meticulously and systematically regulated data is being administered and looked after, they could land themselves in almost as much trouble as they would if their information management systems were fundamentally lacking in some way.
It all comes down to what kind of audit trail information RIM systems are producing. It is not enough to be able to say there are processes around record-keeping, to manage digital signatures, and for ensuring that critical data can’t be tampered with. Owners of regulated processes and data, system owners as well as responsible QA need to be able to prove this, by showing a clear trail of what has happened to data over its entire lifecycle when and who has been involved. This is about maintaining a clear ‘change log’ for all regulation-controlled data.
The ability to measure and demonstrate data integrity is a feature that should be embedded in any decent RIM system already, but often firms are failing to use it - or have neglected to harness it in a way that could really benefit them.
It’s a topic that’s crept up industry conference agendas at least over the last 18-24 months - as developments such as IDMP and more generally GDPR (the new EU data protection regulation, which comes into play this May), have brought data integrity and data quality assurance into the spotlight.
So it’s something we’ll be examining in more detail at this summer’s AMPLEXOR Be The Expert event. Because 37 Centigrades' time in this industry has spanned regulatory and quality roles, we have seen first-hand where the gaps are – where companies are letting themselves down, and potentially leaving themselves open to risk as regulatory inspections with a clear data integrity objective are a reality nowadays.
As well as highlighting the issue, we’ll be offering some practical advice on how to exploit the inherent data integrity facilities within RIM products such as AMPLEXOR’s Life Sciences Suite.