This is a statement of our position of compliance of PanatrackerGP with the FDA’s 21 CFR Part 11. More information on this regulation can be found at the FDA's site here: FDA CFR Title 21 Part 11
Panatrack has made every effort to meet all necessary regulatory requirements that fall within the control of a software provider. It must be understood, however, that certain activities such as certification of electronic signatures, database-level protection of audit data, training and Standard Operating Procedures, password policies, and such other “Information Technology System Administration” processes fall outside of the scope of our compliance influence. We believe that with solid infrastructure controls established by the customer, our software will assist in complying with the full 21 CFR Part 11 requirements.
We believe that PanatrackerGP meets the requirements as defined in CFR 21 Part 11 Subpart A (General Provisions), and Subpart B (Electronic Records) as it relates to "Closed Systems" (Section 11.10).
- Transactions captured by PanatrackerGP are driven by barcode scans to help ensure the accuracy of data captured.
- Each transaction recorded by PanatrackerGP is recorded in audit tables and passed to the host system, Dynamics GP, for further processing (also typically logged again). Transaction logs are read-only by design and there fulfill Part 11 requirements to ensure that data is limited to authorized individuals, cannot be altered, and may be retained indefinitely.
- As data is stored in SQL Server, reports can be run in order for the customer to meet additional requirements stated for record retention and other operating procedures.
PanatrackerGP does not, by design, use Electronic Signatures as a “legally binding equivalent of traditional handwritten signatures”. Therefore, we view Subpart C (Electronic Signature) compliance as not applicable.