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Learn about the challenges the Pharmaceutical industry faces with archiving data and how you can overcome these
Hana Laws, Principle Consultant, Information Governance at Iron Mountain takes a look at Information Governance through a Pharmaceutical lens.
In many industries, we think of raw data as lists of numbers or individual bits of information that are disorganised and unprocessed, which on their own have no meaning and no particular value. It’s only after it’s collected, organised, processed and used to add context that it then forms a ‘record’ of something. Most likely in a document, a completed form, a report or such like.
For most, it’s unlikely that you’ll ever need to refer back to the data so we just ensure we look after the record until it can be disposed of. Not having to worry about all the redundant data and just focusing on managing tangible, identifiable records isn’t as easy as it sounds, but if you’re in the Pharmaceutical industry, things just got a whole lot more complicated!
The first challenge faced in the highly regulated Pharmaceutical industry is the strict regulatory and legislative requirements to ensure Data Integrity, and rightly so. In the scenario of manufacturing drugs for example, we would absolutely expect robust controls to be in place to enable traceability from the very start of clinical trials and testing right through to licensing, product development, manufacturing, prescription and administration.
When that data and the records are still active, because the drug is still being manufactured, IT systems and software, laboratory systems and equipment are all maintained, licenced and accessible. No problem, we can trace the information back to its source and access it easily as and when needed.
But what happens when the manufacturing of a drug is terminated or the clinical trials are stopped, for any reason, and the laboratory systems decommissioned along with any digital or physical data or records archived? There are a whole host of things to consider to ensure that the data and records retain their integrity, traceability, accessibility and readability for possibly the next 10 years or more. Not to mention finding a cost effective solution. Easier said than done! Why?
Some laboratory systems are designed, commissioned and built for a very specific purpose, often utilising proprietary software and requiring specially trained technicians. If the data is unlikely to be accessed for the remainder of its retention period, it’s probably ill-advised to maintain the same very costly systems, software and specialist administrators. Cheap solutions such as traditional backup tapes may seem appealing but if there is no specialist software available in 5 or 10 years time to read the data, is it too much of a risk?
Whatever the solution, it must be able to retrieve, reconstruct and read the data exactly as it was originally. In case of a regulatory inspection, it must be retrievable within a short time frame, so archiving together with appropriate metadata which allows an easy and user-friendly search is crucial. Does such a solution exist? I think it does, but how do we get there?
Given that this scenario is a common, repeatable situation in many organisations, it’s surprising to see that a tactical, traditional approach is still typical. Project teams are mobilised to react and tackle individual requirements without considering the bigger picture. Could this be due to a lack of Information Governance maturity?
As an Information Governance professional, I can’t seem to stop using the current buzzword silos right now. And this is a perfect example of why good Information Governance is essential.
The core concept of Information Governance is cross functional collaboration, supported by a shared governance framework, led by a senior Information Governance sponsor to drive information strategy, policies and appropriate (in this case IT) solutions, which will ensure risks are managed, compliance is met, costs are managed, value is extracted from information and commercial advantage is won.
This will not be achieved in silos though. Post pandemic we are definitely seeing more collaboration generally and this has got easier with the introduction of new technology, but we also need to improve collaboration of the Information Governance agenda at a strategic level.
In this specific Pharmaceutical scenario, an ideal situation would be to take a step back, gather the right stakeholders together and develop an organisation-wide, information strategy and solution (or a few), to enable the archiving of inactive raw data and associated records in a repeatable, cost effective process which is, for the best part, future proof. This may require investment of people and resources up front but it’s got to pay dividends in the end.
The principles and lessons learned are applicable to all information, active or archived, in all organisations, in all industries. Information is recognised as a critical business asset, I think that’s well accepted now, but there is still a way to go to treat it as such and truly extract its value.
I could do with a new buzzword, so get Information Governance firmly positioned at the exec top table and away with the silos!
Learn more about Iron Mountain’s Information Governance Advisory Services.