How to Manage GLP Archives
Keep a study retrievable and readable for as long as it may be relied on.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
A nonclinical study can be relied on decades after it was run, and the archive is what makes that possible. Good laboratory practice treats archiving as a controlled function with a named archivist, defined access, and retention that outlives the people and usually the software. The failure is rarely loss — it is retrieval that takes weeks, or electronic data in a format nothing can still open.
- 1
Name an archivist and control access
One individual is responsible for the archive, and access is restricted and recorded. An archive that any study scientist can enter and remove material from is a store room, and its contents cannot be relied on to be complete.
- 2
Index on deposit so material can be found, not only kept
Record what was deposited, for which study, when, and where it sits. Retrieval time is the honest measure of an archive: material that exists but takes a week to locate fails the purpose it was kept for.
- 3
Archive raw data, the plan, the report, specimens and samples together
The whole evidential set travels together — raw data, study plan and amendments, the final report, specimens, reserve samples, and the quality assurance records. A study split across several stores with no map is reconstructible in principle only.
- 4
Set retention from the applicable requirement and the study’s use
Retention periods differ by regulation and by what the study supports. Where several apply, the longest governs, and destroying at the shortest because it came to hand first is a decision nobody documented.
- 5
Plan electronic readability explicitly
Electronic records must remain readable for the retention period, which will outlast the software. Decide between maintaining the system, verified migration, or a validated rendering — and re-verify periodically rather than assuming what was readable at deposit still is.
- 6
Control transfer and destruction with a record
Where an archive moves — a facility closes, a sponsor takes custody — the transfer is documented and the receiving archive accepts it formally. Destruction at end of retention is authorised and recorded; material that simply disappears is indistinguishable from material that was removed.
- !No named archivist and uncontrolled access, so completeness cannot be assured.
- !Material indexed only at retrieval, making location time the real failure rather than loss.
- !The shortest applicable retention period applied when a longer one also governs.
- !Electronic readability assumed rather than periodically re-verified against the current environment.
How to Manage GLP Archives: frequently asked questions
Common questions on manage glp archives.
What has to go into the archive?
The whole evidential set for the study: raw data, the plan and its amendments, the final report, specimens and reserve samples, and the quality assurance records. Splitting these across stores without an index makes the study reconstructible in theory and not in practice.
How long is long enough?
It depends on the regulation the study supports and on how the study is used, and where more than one requirement applies the longest governs. The decision should be recorded per study rather than applied as a facility default, because a default is what leads to destroying material still required elsewhere.
What happens to the archive if the facility closes?
It transfers, with a documented handover accepted formally by the receiving archive, commonly the sponsor’s. An archive that is boxed and moved without that record leaves studies whose custody chain has a gap, and the gap is what gets questioned.