RECORDREFERENCE OUTLINE

Raw Data Definition Register

Per-system register answering which record is the raw data, because the answer differs between an instrument that writes a final value and one that acquires a signal then processes it. Covers acquisition versus processed output and whether a result can be regenerated, attributability and shared logins, the correction method per system, and archive format checked against the retention period. Maps to OECD GLP Advisory Documents No. 17 and No. 22.

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
OECD GLP Advisory No. 22OECD GLP Advisory No. 17
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

Raw data are the original records from which the study report is derived. In a paper facility that was obvious; with instruments that acquire, process and re-process, it stopped being obvious and must now be answered deliberately for each system. That answer is your determination, not the vendor’s, and an unanswered system is one whose archive may hold no original at all.

What's Inside

✓Per-system raw data definition recording who decided it, on what basis, and when
✓Acquisition file versus processed output, and whether the reported result can be regenerated from the original
✓Attributability per system, including any shared login and what it does to the record
✓Audit trail status per system — present, enabled, reviewed — and the person who reviews it
✓How a correction is made on each system, and what the corrected-over value leaves behind
✓Archive format per system, checked against the retention period that actually applies to it
✓Remediation entries with owners and dates for every system that fails one of these tests

How to Use It

1Answer per system rather than once for the facility; the answer genuinely differs between an instrument writing a value and one acquiring a signal.
2Where processing is applied, treat the acquired file as raw data; retaining only processed output leaves an archive with no original.
3Record whether a reported result can be regenerated from the original, because that is the test an auditor actually runs.
4Treat any shared login found here as a finding with a remediation date; it makes every record from that system unattributable.
5Compare archive format against retention; a proprietary format that will not outlive the retention period means the record is already lost.
6Re-open the register whenever a system is upgraded or replaced, since an upgrade can silently change what the instrument keeps.
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
1Per-System Raw Data Definition
2Acquisition Versus Processed Output
3Attributability and Audit Trail
4Correction Method Per System
5Archive Readability
REGULATORY CONTEXT

OECD GLP Advisory Document No. 22 addresses data integrity in the GLP environment and No. 17 the application of the GLP Principles to computerised systems; together they set the expectation that raw data is identified, attributable and retained. Neither names the raw data for your particular instrument — that determination belongs to the facility and must be recorded, per system, with its reasoning. The register structure is SPEQ practitioner synthesis, and this template renders as a spreadsheet because it is a per-system register.

MAPPED STANDARDS
OECD GLP Advisory No. 22OECD GLP Advisory No. 17
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