Data Integrity has become a ‘hot’ topic
The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. That said – data integrity is not just about computerised records. It is about keeping all records, including paper-based records, safe and secure, accessible and free from damage, alteration and deterioration. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.
This is the Domesday Book, a manuscript recording the “Great Survey” of much of England, completed in 1086 by order of King William the Conqueror. It was a record of what England was at the time; the cities and towns, populations, number of inns, churches, farms, cows and sheep, etc. It currently resides in Kew Gardens in London.
In the mid 1980’s, to mark the 900th anniversary of the publication of the Domesday Book the BBC embarked on a grand project to replicated the Domesday Book for the modern world. Thus started the BBC Domesday Project, involving thousands of school children up and down the country collecting data, photographs and surveys of their own towns to create a new survey of the whole of the United Kingdom. I was one of these children – who spent many a wet Saturday afternoon taking to people in my home town about that they did for a living, the type of house they lived in, number of children, pets, how they got to work, etc. In 1986 this was then produced – the finished article. Two laser discs worth of information – accessible by a BBC Microcomputer. Amazing!
Now, 30 years later we have a bit of a problem! As this is the last working BBC Micro in the world that can read the laser discs that the project was saved on. So after just 30 years the project is (excuse the pun) doomed itself. It is not that the data is not there, it is that the software and hardware needed to access the data is no longer freely available. Whereas, still residing in Kew Gardens is the original work, which needs no technology to read it at all.
This is one of the problems with data integrity, especially with regarding to storing data electronically. We often discard items of equipment when we have finished using them, without realising that the item is essential to read data that is stored somewhere. And this continues today. I have videos at home with no VCR to watch them on, and I have music on LPs and CDs, with no hardware to play them on either. Now on the grand scheme of things this is not that serious, and a problem can be found. However, in a regulated environment, such as pharmaceuticals, where the keeping of data for a long time is essential, then do ensure that you that you have the right policies and procedures in place to ensure that critical data is not lost or made inaccessible over time.
Update to post May 2017
New guidance now available on EMA’s website
The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.
EMA’s GMP / Good Distribution Practice (GDP) Inspectors Working Group has developed a set of questions & answers with advice for stakeholders on measures that ensure data integrity and minimise risks at all stages of the data lifecycle in pharmaceutical quality systems. The advice applies to both paper-based and electronic systems. It specifically addresses:
- assessment of risks to data integrity in the collection, processing and storage of data;
- risk management measures at various stages of the ‘data lifecycle’;
- design and control of both electronic and paper-based documentation systems;
- measures to ensure data integrity for activities contracted out to another company.
The document is aligned with existing GMP guidance published by some regulatory authorities participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). It should be read in conjunction with national guidance, medicines legislation and the GMP standards published in Eudralex volume 4.
If you need any help or support in this area, then please get in touch. You may also want to consider attending our one-day Data Integrity training course.
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