Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application

• Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, the Member will authorize BOMcheck to certify the Member’s electronic signature arrangements with the US

integration of Windows integrated security and centralized server based architecture, operators have one, central location to manage individual accounts, monitor access and

seminars. For more information and ordering, visit www.labcompliance.com/solutions.. Whenever records have been identified to be part 11 records, they should follow the US

For records submitted to the agency, persons may use electronic records in lieu of paper records or InfinityQS SPC applications capture and store quantitative and qualitative records

(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to

CFR Part 11 requirements 1-19 Use of Digital Signatures for Open Systems - 11.30 "Persons who use open systems to create, modify, maintain, or transmit electronic records shall

– 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

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be