APQR / PQR software that builds your Annual Product Quality Review from live data instead of a six-week spreadsheet exercise.
Every regulated product needs an Annual Product Quality Review (APQR in FDA-speak, PQR in EU-speak) — a defensible look-back across every batch, in-process test, QC result, stability datapoint, deviation, CAPA, complaint, change and returned/recalled unit for the period, with a signed conclusion about the state of validation. V5 replaces the six-week Excel exercise with a live product review that pulls the data continuously and needs only interpretation, not assembly.
You're shopping because APQR season means six weeks of copy-paste from batch records into Excel, trends are built by hand, and last year's conclusion nobody can find.
APQR is a spreadsheet exercise — six weeks of pulling batch data, in-process results, QC tests, stability and deviations by hand
Trends are drawn in Excel by one person; nobody else can reproduce the analysis
Deviations, CAPAs and changes for the period are pulled from three different systems and reconciled manually
The conclusion on state of validation is a paragraph nobody defends because the underlying data isn't linked
Returned/recalled units and complaints get a mention but not an integrated view alongside process performance
Last year's APQR is a PDF in a folder — nobody can compare year-over-year without opening both
APQR, built from live data.
Automated data pull across the entire product record
The APQR pulls every batch record, in-process check, QC test, stability datapoint, deviation, CAPA, change, complaint, and returned/recalled unit for the product and period. Nothing is re-keyed from another system — the review is a lens over live data, not a static copy.
Trending with control charts & capability
Critical quality attributes, in-process parameters and QC results are trended with Levey-Jennings, X-bar/R, and Cpk/Ppk views across the batches in the review period. Adverse trends and process shifts surface as findings, not as a manual eyeball on 500 rows.
Deviation / CAPA / change linkage
Every deviation, CAPA and change touching the product in the period is surfaced with its status, criticality, root cause category and effectiveness. The review sees the complete change history and can attribute a trend shift to a specific change — because the linkage is data, not narrative.
Section templates with review conclusions
The APQR is a structured document — starting materials, critical process parameters, in-process controls, finished-product results, stability, complaints, returns, recalls, deviations, CAPAs, changes, validation status — each section auto-populated with data and open for the reviewer's written conclusion. Signed conclusions are Part 11 e-signatures on the section.
Year-over-year comparison built in
Prior years' APQR data stays queryable — this year's trend chart overlays last year's, this year's deviation counts sit next to last year's, this year's Cpk sits against last year's. State-of-validation conclusions have a real baseline, not a paragraph in a PDF.
Signed, dated, distributed
Section-by-section review sign-off (production, QC, QA); QP / responsible person signature on the conclusion; controlled distribution to plant leadership; retention against the product's record. The finished APQR is an evidence artefact, not an email attachment.
What changes the day this goes live.
- APQR assembly time drops from six weeks of copy-paste to a review of pre-built sections
- Trends are reproducible — the analysis lives on the data, not in one microbiologist's spreadsheet
- Every deviation, CAPA and change on the product in the period is on the review — nothing gets missed
- Year-over-year comparison is a click, not a document hunt
- State-of-validation conclusions have a defensible data trail, not just a signature
The frameworks a product-review owner has to satisfy.
21 CFR 211.180(e)
US cGMP — written records of the evaluation, at least annually, of the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing/control procedures. Records include representative batch data and every batch failing to meet specifications.
EU GMP Chapter 1 §1.10
Regular periodic or rolling quality reviews of all authorised medicinal products, conducted with the objective of verifying the consistency of the existing process, appropriateness of current specifications, highlighting trends, and identifying product/process improvements.
ICH Q10 §3.2.2 · ICH Q9(R1)
Process performance and product quality monitoring as one of the four PQS enablers; risk-based prioritisation of findings; management review linkage. ICH Q9(R1) provides the risk-management framework for interpreting review outputs.
APQR / PQR software, answered.
How does V5 pull the data without a separate ETL job?
The APQR runs against the same live database that batch records, LIMS, deviations, CAPAs and changes write to. There's no export, no ETL, no reconciliation — the review is a lens over the operating record. When a late-arriving stability result posts, the APQR sees it; when a deviation closes with a new root cause, the APQR reflects it.
How does V5 handle products manufactured across multiple sites?
A product's APQR can be scoped per site (site-specific PQR) or global (aggregate view across sites). Site-specific reviews use site-local data; global reviews aggregate with the site as a facet — so trends can be compared site-to-site, and site-specific conclusions roll up to the global state-of-validation view.
How does V5 handle contract manufacturing / marketing authorisation holder scenarios?
For MAH-CMO arrangements, V5 supports both sides. The CMO's system produces the manufacturing-side data pack; the MAH's system consumes that pack, adds complaints, PV signals, and market-specific data, and produces the authorisation-holder PQR. The chain-of-evidence is preserved — the MAH's conclusions rest on the CMO's structured data, not a re-typed summary.
How does V5 make the state-of-validation conclusion defensible?
The conclusion sits on top of the trending, the deviation record, the change record, and the stability data — all linked, all queryable, all in one file. When an inspector questions the conclusion, the reviewer clicks through to the underlying data in seconds. The signature is on evidence, not on narrative.
Build APQR from live data.
Free trial. Real data pull, real trending, real year-over-year comparison.