I read guidance for industry Part 11, electronic records; electronic signatures - scope and aplication.
I noticed very interesting sentence. "…When persons use computers to generate paper printout of electronic record, and those electronic records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their reegulated activities, FDA would generally not consider persons to be using electronic records in lieu of paper records…
In this instances, the use of computer systems in the generation of paper records would not triger PART 11" My 1. question is: If one print out analytical record, which contains calculated result from a computerized system and quality decision is based on the paper print-out is analytical record still PART 11 record?
Prior to FDA’s release of the Part 11 Scope and Application guidance in August 2003, the rule was that if the original recording of the record was electronic, then part 11 applies, including the retention of the electronic record per predicate rule retention requirements. This was the case regardless of whether a paper printout was generated or how it was used. Part 11 applied to the electronic source data, or raw data, regardless of whether it was secured from accidental or intentional modification prior to the generation of a printout.
Given the narrower focus on electronic records as described under the Scope and Application guidance, however, FDA’s position on this matter relaxed considerably. As the guidance state : “under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requiremen,ts of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be using electronic records in lieu of paper records under §11.2(a) and 11.2(b). In this instances, the use of computer systems in the generation of paper records, would not trigger part 11.”
Now and in simpler terms :
If the original records are in electronic format and are maintained in place of paper format, then part 11 applies.
If the original records are in electronic format, but you use computer printouts of electronic records (meeting all applicable predicate rules requirements) to perform regulated activities, then part 11 does not apply.
In your case : you generate records that are maintained in electronic format in addition to paper format. You still rely on the electonic format to perfom calculations (regulated activity), then Part 11 applies. In other words, the paper format is irrelevant if you still rely on the electronic format to perform any regulated activities.
I’m not sure that the case interpretation is that simple. With respect to the ‘electronic’ calculation component the predicate rule requirement for validation takes precedence.
Part 11 is triggered if the electronic report/record of the result is used to support GxP decisions.
I’m not sure that the case interpretation is that simple. With respect to the ‘electronic’ calculation component the predicate rule requirement for validation takes precedence. Part 11 is triggered if the electronic report/record of the result is used to support GxP decisions.
What is that performing regulated activties? When the master is in electronic format and that the approvals are made with Paper record then also Part 11 applies in which case the system itself is considered as a Hybrid system.i.e. Electronic + Paper record. But there should be approriate procedures to define how the master record is controlled and how the paper print out is controlled for any changes.
The FDA was driven to extremes by Paul Motise (FDA part 11 instigator) when he made the now infamous comment , “If you use a computer as anything other than a typewriter, it must be Part 11 compliant”.
This put the FDA out on a limb, how could you change every computer in industry from the simple cmos and plc devices to networks, overnight.
This was quickly re-interpreted to mean, if you store regulatory required data electronically, then your storage system must be part 11 compliant. Not all people agreed and many companies stuck to Motise’s original interpretation and were guided into horrendously expensive solutions for this requirement.
Product data (i.e. all the manufacturing records, testing records, storage records) are all held along with sample of the batch the records apply to, for the life of the batch plus 2 years. When all these records were paper based the retention of these records was simple and could be verified with simple visual inspections.
The FDA was right in their fear that if left uncontrolled electronic records would not be as robust as the paper system, and would quickly become an out of control mess. So the legislation was brought in to make electronic records secure. Nothing else, just predicated product data stored purely electronically, would have to be stored in a manner that ensured their integrity was never compromised.