For someone who is well experienced within a solid QMS, yes. They would be able to interpret exactly how each requirement can be met. But for new people to ISO, or a QMS, or new to a regulated industry, No. I do not think 7.5.2 and 7.5.3 provides the level of clarity and respect raw data demands.
For the overwhelming majority of organizations using ISO 9001 a requirement related to the management of raw data would be far fetched and impossible to comply with. Standards, by definition, have to limit themselves to basic, universally adoptable requirements.
Bev D, you get it!It really is about more than what ISO covers. It’s not just about ‘fraud’. The two areas I tend to focus on are the torturous paths of data transfer across multiple systems (been bit by that!) and the transparency and availability of data (huge area of risk).
Most of you know that what I dislike about the standards is that they are a minimal standard and too many organizations try to contract lawyer their way out of good quality as well as the abusive punitive and ignorant auditors that overstep ( no one here of course). So like everything, ISO is more likely to get it wrong and vaguely over reach on this too….
Good point
Well, if you want to totally ignore ISO 9001 7.2 then sure you can throw new people into addressing 7.5.2 and 7.5.3 without support.
Not sure what your point is? Often we interpret things thru our own experiential lense. For clarity my lense is that 7.2 covers competence which is rarely well assessed, assured or controlled in salaried personnel. 7.5.2 and 7.5.3 concern ‘information’ document control - basically and generally used to apply to words. In fact I’ve had many auditors and quality people (who should be competent in interperpreting the standard) tell me that 7.5.2 and 7.53 only apply to the information contained in SOPs, work instructions and Drawings (which have numbers representing the specification limits and few words). What Data integrity refers to is numbers. Numbers generated by experiments V&V studies and control/inspection measurements stored in quality records and resulting from direct measurements and calculations. These things don’t have revision control as changes to data are not allowed except under certain circumstances. The origination of data integrity is with pharma.
I've often wondered what the qualifications were of the person(s) who awarded the 1st Ph. D. (or any other "1st" credential).
