Source: https://trackmycrop.wordpress.com/2012/05/16/overall-approach-to-part-11-requirements/
Timestamp: 2017-04-28 18:05:31
Document Index: 700147467

Matched Legal Cases: ['art 11', 'art 11', 'art 11', '§ 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Overall Approach to Part 11 Requirements | trackmycrop
« FoodNet Shares Lessons From More Than a Decade of Data
How Processors are Affected by the FSMA »
May 16, 2012 by trackmycrop Narrow Interpretation of Scope
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 requirements 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 these instances, the use of computer systems in the generation of paper records would not trigger part 11.
Definition of Part 11 Records
Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records.
Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities.
Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format.
Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).
Legacy Systems7
Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)
Posted in Food Safety, Food Safety Modernization Act, Tracking | Tagged CFR, FDA, FSMA, recordkeeping, SOP | Leave a Comment	Comments RSS