Process family
Laboratory data review: from raw data check to an issued report or CoA
Seven laboratory data review flowcharts: data review, notebook review, report approval and Certificate of Analysis in sequence, with chromatographic data review, data integrity review and laboratory document control alongside.
Laboratory data review is the gate between a result that exists and a result that can be used. A reviewer confirms the record is complete, attributable and consistent, the notebook entry is checked as the record of the work, the report is prepared from approved data and authorised, and a Certificate of Analysis carries the result outside the laboratory. This family orders those four steps and adds the specialist reviews behind them.
The result package from testing enters at laboratory data review: completeness and traceability checks, calculation verification, discrepancy assessment and reviewer approval. Notebook review runs alongside on the entry itself, preserving the original while making queries and corrections traceable. Laboratory report approval then takes the approved data package, prepares the report, obtains release authorisation and records distribution; for a batch or lot the same approved results are compiled into a Certificate of Analysis with the correct sample, method, specification and authorisation details.
The failures are the ones a regulator finds later: an integration reprocessed until the peak passed with no audit-trail reason, a calculation nobody verified against the raw data, a CoA issued against a result still under investigation. Chromatographic data review is built for the first: run context, processing choices and audit-trail evidence reviewed together before a data set is approved. The data integrity review is the triggered version for when a record's reliability is in question: scope, provenance, containment. An unresolved discrepancy leaves for triage in laboratory investigations.
Laboratory document control sits behind every step: the SOP the analyst followed, the review checklist and the report template each need an owner, technical review, quality approval and an accessible current version, and a review is only as good as the version it was done against. The wider controlled-document cycle is document control. A CoA for a finished product feeds batch release in the quality family, and a report from a contract laboratory gets its own review under outsourced testing.
The sequence
Step 1: Laboratory data review process flowchart
A laboratory data review workflow for completeness and traceability checks, calculation verification, discrepancy assessment, corrections, reviewer approval and a controlled result record.
Step 2: Laboratory notebook review process flowchart
A laboratory notebook review process chart for screening entries, checking calculations and attachments, resolving queries, escalating record concerns and signing the review.
Step 3: Laboratory report approval process flowchart
A laboratory report approval process chart for clarifying the request, preparing reports from approved data, resolving technical issues, obtaining authorization and recording distribution.
Step 4: Certificate of Analysis (CoA) process flowchart
A Certificate of Analysis process for compiling approved results, confirming reportable information, resolving discrepancies, authorized approval, controlled issuance and record retention.
Also part of this family
- Chromatographic data review process flowchart — A chromatographic data review process chart for confirming run context, reviewing integration and audit trails, resolving processing queries, assessing results and approving the review record.
- Laboratory data integrity review process flowchart — A laboratory data integrity review process chart for scoping affected records, assessing provenance and audit-trail evidence, containing concerns, assigning follow-up and documenting disposition.
- Laboratory document control process flowchart — A laboratory document control process chart for defining document ownership, drafting revisions, resolving technical and approval comments, and publishing the current controlled version.
Used in these industries
Related guides
- How to create a document control process — How to build a document control process that governs the superseded copy as well as the new one: an identifier and a revision, one authoritative location, a withdrawal step, and a dated periodic review.
- How to version control an SOP — SOP version control means numbering every procedure revision, routing safety-critical changes through hands-on retraining and a signed checklist instead of read-and-acknowledge, and retiring the copy it replaces.