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.