RECORDREFERENCE OUTLINE

GLP Archive Index and Control Record

Archive index built for retrieval rather than storage: material indexed on deposit, per-study completeness across plan, raw data, report, specimens and samples, retention set from the longest applicable requirement with the basis recorded, a named archivist with controlled access, periodic electronic readability re-verification, and controlled transfer and destruction. Maps to 21 CFR Part 58 and the OECD GLP Principles.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
21 CFR Part 58OECD GLP Principles
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

A nonclinical study can be relied on decades after it was run, and the archive is what makes that possible. The failure is rarely loss — it is retrieval that takes weeks, or electronic data in a format nothing can still open. Which retention period governs a given item, where several apply, is your organisation’s determination and must be recorded with its basis.

What's Inside

✓Archive index written on deposit, carrying location, medium and the retention date already calculated
✓Per-study completeness across the study plan, raw data, final report, specimens and samples
✓Retention basis recorded wherever more than one requirement applies to the same material
✓Named archivist with controlled access, each grant and removal dated rather than standing indefinitely
✓Electronic readability re-verification against the current environment, with the next due date set
✓Transfer records for material moving between archives, including who accepted custody and when
✓Destruction records naming the authorisation, so an absent item can be distinguished from a lost one

How to Use It

1Index on deposit rather than on retrieval; material found only when someone asks for it makes location time the real failure.
2Apply the longest applicable retention where several govern, and record which requirement you applied and why.
3Name an archivist and control access, so completeness can be asserted by someone and gaps can be attributed.
4Re-verify electronic readability periodically against the environment you actually run today; retention routinely outlives the software that wrote the file.
5Record specimen and sample condition on deposit, because a retained specimen that has degraded is not a retained specimen.
6Log every transfer and destruction with its authorisation; an unexplained gap in the index reads as a deliberate one.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Archive Index
2Completeness Per Study
3Retention Basis
4Access and Archivist
5Electronic Readability Verification
6Transfer and Destruction
REGULATORY CONTEXT

21 CFR Part 58 and the OECD Principles of Good Laboratory Practice require archives under a named individual with controlled access, holding study plans, raw data, final reports, specimens and samples for a defined retention period. Neither tells you how to index the holding for retrieval, how often to re-verify electronic readability, or which period wins when several apply — those are your determinations. The index structure is SPEQ practitioner synthesis, and this template renders as a spreadsheet because an archive index is a register.

MAPPED STANDARDS
21 CFR Part 58OECD GLP Principles
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