Time Synchronization
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Time synchronization is the control ensuring that the clocks of all GxP computerized systems — and the timestamps they write into records and audit trails — are accurate, consistent, and traceable to a reliable time source. It is what makes the "contemporaneous" and "attributable" elements of ALCOA+ verifiable across systems.
Without synchronized, protected clocks, timestamps can be wrong or manipulated, allowing records to be back-dated or the true sequence of events to be obscured. Systems should draw from a controlled time source (e.g. a network time server) and users must not be able to alter the system clock.
Time zone handling and daylight-saving transitions are common pitfalls: records generated across sites or servers must be reconcilable, so the applied time zone should be recorded or normalized to avoid apparent inconsistencies that read as data-integrity issues.
- —Clocks traceable to a controlled, reliable time source.
- —Users cannot alter the system clock.
- —Underpins the contemporaneous and attributable ALCOA+ elements.
- —Time zone / DST handling must keep records reconcilable.
PIC/S PI 041-1 (2021) clock synchronization expectations; MHRA GXP Data Integrity Guidance (2018).
Frequently asked questions
What is Time Synchronization?
Time synchronization is the control ensuring that the clocks of all GxP computerized systems — and the timestamps they write into records and audit trails — are accurate, consistent, and traceable to a reliable time source. It is what makes the "contemporaneous" and "attributable" elements of ALCOA+ verifiable across systems.
Which regulations cover Time Synchronization?
PIC/S PI 041-1 (2021) clock synchronization expectations; MHRA GXP Data Integrity Guidance (2018).