REPORTREFERENCE OUTLINE

GLP Final Study Report

Final report carrying the two elements that make it a GLP report rather than a scientific write-up: the study director dated compliance statement naming the deviations, and the quality assurance statement. Methods described as performed against as planned, every deviation with an impact assessment, a traceability table from each result to its raw data, signed contributing reports attached, and amendment control after signature. 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.

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

The final report is the study — everything else is working material. Two elements make it a good laboratory practice report rather than a scientific write-up: the study director’s dated compliance statement naming the deviations, and the quality assurance statement. Neither can be added convincingly at the end if the study was not run to support them, which is why both are designed in at the plan stage.

What's Inside

✓Study, test item and facility identification, including the characterisation the reported results depend on
✓Methods as performed set beside as planned, so the difference is stated rather than discovered
✓Deviations listed individually, each with its effect on the study and on the conclusions
✓Traceability table linking every reported result back to the raw data behind it
✓Contributing scientists’ reports signed and attached rather than paraphrased into the main text
✓The study director’s dated compliance statement naming the deviations, not asserting their absence
✓Quality assurance statement and the amendment control governing the report after it is signed

How to Use It

1Describe methods as performed; a section copied from the study plan describes intention, and an auditor comparing it to raw data finds the gap first.
2Give every deviation an impact assessment; a bare list leaves the reader to assume the worst about each one.
3Build the traceability table as results are drafted, not afterwards, or the table documents the report rather than the data.
4Attach signed contributing reports rather than paraphrasing; paraphrase removes the author’s signature from their own conclusion.
5Name the deviations in the compliance statement; a statement claiming full compliance against a file full of deviations destroys the report.
6After signature, change the report only by formal amendment; editing a signed report breaks the traceability the signature created.
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
1Study, Test Item and Facility Identification
2Methods as Performed
3Deviations and Their Effect
4Results and Traceability
5Contributing Scientists
6Statements and Amendment Control
› Study director compliance statement› Quality assurance statement
REGULATORY CONTEXT

21 CFR Part 58 and the OECD Principles of Good Laboratory Practice set the final report content requirements, including the study director’s compliance statement and the quality assurance statement, and require amendments to a signed report to be formally controlled. Neither writes your impact assessments, decides which deviations mattered, or judges whether your conclusions follow from your data — those remain the study director’s, and are what the statement puts a name against. The report structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 58OECD GLP Principles
Browse the standards catalog →