PanatrackerGP meets the requirements of FDA 21 CFR Part 11 for closed systems as they relate to electronic records. This document outlines Panatrack's position on compliance with this regulation.

More information on this regulation can be found at the FDA CFR Title 21 Part 11 website.

Compliance Statement

Panatrack has made every effort to meet all necessary regulatory requirements that fall within the control of a software provider. However, certain activities fall outside the scope of software provider compliance influence, including:

• Certification of electronic signatures
• Database-level protection of audit data
• Training and Standard Operating Procedures
• Password policies
• Other Information Technology System Administration processes

With solid infrastructure controls established by the customer, PanatrackerGP assists in complying with the full 21 CFR Part 11 requirements.

Regulatory Coverage

PanatrackerGP meets the requirements as defined in CFR 21 Part 11 Subpart A (General Provisions) and Subpart B (Electronic Records) as they relate to "Closed Systems" (Section 11.10).

Specifically:

• Barcode accuracy — Transactions captured by PanatrackerGP are driven by barcode scans to help ensure the accuracy of data captured.
• Audit trail integrity — 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 fulfill Part 11 requirements to ensure that data is limited to authorized individuals, cannot be altered, and may be retained indefinitely.
• Record retention — As data is stored in SQL Server, reports can be run to meet additional requirements stated for record retention and other operating procedures.

Electronic Signatures

PanatrackerGP does not, by design, use Electronic Signatures as a "legally binding equivalent of traditional handwritten signatures". Therefore, Subpart C (Electronic Signature) compliance is not applicable.