The second in a series of articles about Data Integrity.
The first one talked about ALCOA – a good start, but there’s so much more…
Let’s start by thinking why DI is important in the first place. It really isn’t there just to make life difficult and give inspectors something to look for. No, really, it isn’t.
Patient safety – it all starts and ends with patient safety. Product release is based squarely on raw data – and if that data doesn’t have integrity (isn’t valid) there could very well be issues with the quality of the product – and that reaches to the heart of what we do in the Pharmaceutical Industry. One job people, one job…
The FDA have been sending out warning letters like confetti as a result of failures in data integrity. MHRA are interpreting the concept of data integrity very strictly indeed.
So – whether you take DI seriously because you understand its importance to patient safety, or just because you don’t want to come a cropper with the FDA or MHRA, the fact remains it needs to be taken seriously.
When we talk about data, we’re not just referring to the computer-based variety – it includes data on paper, and that includes both hand-written and printed.
ALCOA has been the refrain that has guided the quest for data integrity ……
But now some more letters have been added. It makes a mess of the mnemonic, but hey, say it with me – ALCOACCEA. Gimme an A, gimme an L… So, assuming you’re secure in your knowledge of ALCOA, here’s the rest.
C – Complete. The data must be complete, and that includes the meta data. There shouldn’t be any gaps – or at the very least, any unavoidable gaps should be explained.
C – Consistent. Both the data itself (for example if data is taken from more than one source) and the format of the record must be consistent.
E – Enduring. It must last for the full length of the data lifecycle. Electronic data must be stored on durable media. But how long is the data lifecycle? About as long as a piece of string…
A – Available. You have to be able to retrieve it. There’s no point in keeping all this attributable, legible, contemporaneous, original, accurate, complete, consistent and enduring data if you can’t furkling well find it when you need it. Inspectors really don’t like that. And a print-off of your computerised data is no substitute for the actual, original data. You can verify it, sign it, gold-plate it, but it still won’t be compliant with the requirements.
J-GMP offers advice and training on data integrity. Contact us, we can help.