Nonclinical & Laboratory (GLP)
Reconstructable safety studies, independent QA, and controlled archiving.
What a domain score is not
A domain is one of the axes SPEQ’s assessment scores, on SPEQ’s own five-stage progression. It is a labelled synthesis, not the FDA’s Quality Management Maturity rating, and a score here is a self-assessment — nobody but you has rated your organization.
Good Laboratory Practice exists so a non-clinical safety study can be reconstructed years after it ran. The pillars inspectors probe are the independence of the quality assurance function and the integrity of archiving — if the raw data and the QA sign-off cannot be trusted, neither can the study.
The mature form of this domain is reconstructability: a study that can be rebuilt from its raw data and records by someone who was not there. Low maturity produces studies that are defensible because the people who ran them can explain them. The other axis is the independence of quality assurance — in a mature operation QA inspects phases against the protocol and reports to management independently of the study director, and its findings change something; at low maturity QA reviews the report rather than the conduct.
- Fix the identity of the raw data for each measurement, and say where it lives. Most GLP reconstructability failures are ambiguity about which record is the original.
- Make the study director’s single point of control real: one person accountable for the conduct, interpretation and reporting of the whole study, including the phases performed elsewhere.
- Put QA inspections on phases while they are happening, not on the report after it is written.
- Keep the characterisation and stability of test and control items current — a study is only as reconstructable as the knowledge of what was administered.
Ask whether an archived study can be reconstructed by a person who was not involved; that exercise is worth more than any metric. Otherwise: the proportion of QA findings raised during conduct rather than at report review, and the number of amendments and deviations per study — not to minimise them, but because a study with none recorded is rarely a study without any.
The observable behaviours that place a site at each level — what a practitioner or inspector would actually see — and the concrete move that carries it to the next.
- ·Study conduct is not consistently documented
- ·Raw data and reports do not always reconcile
- ·No independent QA function
TO ADVANCE →Establish study plans, SOPs, and defined roles (study director, QA) per GLP.
- ·SOPs exist but adherence is variable
- ·QA inspections are sporadic
- ·Archiving is disorganised; retrieval is slow
TO ADVANCE →Stand up a functioning GLP QA program with a defined inspection schedule and controlled archives.
- ·Study director accountability and QA inspections are routine
- ·Raw data, plan, and report reconcile cleanly
- ·Archives preserve records and specimens with controlled access
TO ADVANCE →Trend QA findings and laboratory data so systemic issues surface across studies.
- ·QA findings are trended and drive systemic fixes
- ·Instrument and method performance is monitored
- ·Data-integrity controls are verified, not assumed
TO ADVANCE →Move to predictive quality — anticipate data and compliance risk from trends.
- ·Data and QA trends predict and prevent issues
- ·Method and instrument reliability is engineered in
- ·Knowledge flows between studies and programs
- A study plan, raw data, and the final report for a named study, reconcilable end to end
- The GLP QA program: inspection schedule, findings, and the QA statement
- Archive arrangements demonstrating retention, retrieval, and integrity of records and specimens
Want the specific artifacts that move your score up? The Comprehensive assessment turns your domain scores into a prioritised, personalised remediation plan.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How are GLP study data and archiving controlled?
Raw data retained informally; archiving is inconsistent
Archive SOP exists; QA inspections are irregular
Independent QAU, master schedule, and controlled archiving per 21 CFR 58 / OECD GLP
Validated archival with ALCOA+ controls and periodic archive-integrity checks
Validated e-archive with continuous ALCOA+ monitoring and predictive archive-integrity verification
How independent is quality assurance from study conduct and operations?
QA and operations share personnel and reporting lines
QA nominally separate but under operational pressure
Independent QA function with defined authority and escalation
QA independence reinforced by metrics reported to senior management
A quality culture with structurally guaranteed QA independence; QA performance is benchmarked and reported to the board
- ›The QA function is not independent of study conduct and operations.
- ›Raw data and specimens not archived under controlled, reconstructable conditions.
- ›Study plans and amendments not properly authorised; deviations undocumented.
- ›Missing master schedule or incomplete study records (21 CFR 58 / OECD GLP).