Data integrity and the use of technology is under scrutiny now more than ever. In recent years, it has really entered the limelight. I am sure many quality professionals will tell you they’ve had sleepless nights before inspections thinking about this very topic.
There is an abundance of case studies out there regarding falsified data. You only have to open the page of FDA warning letters to see just how much focus data integrity is demanding. In response to the growing scrutiny, in 2016, the MHRA released its GxP Data Integrity Draft Guidance document.
One of the solutions presented to combat data integrity issues is to invest in technology. Regulators are certainly looking for the use of technology as, candidly, correctly configured automation is more reliable than humans. If they see technological systems that are validated and implemented already, there are automatically less risks associated with that company.
Truth be told, data integrity is a very basic principle. One of which scientists will have had to adhere to, probably from school age. As we all know, when inspecting, the MHRA and FDA often refer to ALCOA principles (Attributable, Legible, Contemporaneous, Original and Accurate). These foundations are nothing new. It is simply ensuring and providing evidence that the data you submit is not fraudulent.
One major police breakthrough comes from the story of Steven Eaton. If you cast your minds back to 2013, Steven Eaton became the first person in the UK to be jailed under scientific safety laws for falsely reporting data. At the time, he was working on a new cancer drug but irregularities led to the company informing the MHRA, who carried out a full investigation and found that he had been selectively reporting data. Had this been used to justify marketing this product, peoples’ lives could have been at serious risk. This is why the use of technology within data integrity is so important. It is about protecting the patient.
On the one hand, technology is the answer to all your data integrity problems. But with any technology that is used in GMP (or other regulated environments), it comes with a hefty price tag. The minute you buy a system suitable for GMP, it is automatically charged at a premium. Forgetting the initial outlay, you then have the costs to implement, validate and maintain that system. For smaller companies, it just isn’t financially viable to be able to do this. Similarly, if we look at the way technology has progressed over the years, the system you buy now could be obsolete in no time. Just look at how computers and mobile phones have progressed in the last ten years. Processing speeds double every six months.
Inspectors understand that an investment in technology is not always the best way forward for a company. Even if this is the case, you definitely should expect your data to be interrogated in more detail. Inspectors will want to see that controls are in place for the systems you use. Things such as: seeing spreadsheets are locked down, reported data has a clear checking process and showing that you have applied risk management principles etc. will be important in your justifications.
For larger organisations, technology is a must. Being able to access data globally is hugely advantageous. Looking at the difference between paper and electronic records, there is no difference in the regulations regarding the time for storing data between the two different formats. Data needs to be kept for a number of years; sometimes for the lifecycle of the product. Being in a recall situation is everyone’s worst nightmare. If you do find yourself in that situation, it could well be years after you submitted the data. Finding non-electronic versions of that data may take weeks – never mind the cost and space implications of storing physical copies. There is also a much bigger chance of the records getting lost or damaged whilst in storage.
Two key questions to ask yourself are: Is technology really the best option and when is the right time to invest? Ultimately, it comes down to these two deciding factors: size and money. You need to look at whether technology will save you time and, as a result, money. When you have too many paper records and you notice mistakes are made that could be rectified with technology; that’s when you need to consider taking the plunge and investing.
In summary, technology aims to:
- Make people’s jobs easier.
- Allow us to become more efficient.
- Make it as close to impossible as you can get to being able to falsify data.
- Help you justify to an inspector that your data integrity is up to standard.
There is always a cost-risk benefit associated with any technological investment and it is certainly a long-term, continuous commitment. Subsequently, implementing technology should mean the number of mistakes made decreases, meaning there is less need for rework which, in turn, leads to increased efficiencies. The last thing you want to do is find your company named and shamed for being non-compliant. It will mean you have put patients’ lives at risk.
Is now your time to invest?