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Lots. Trends. Deviations. Yields. APQR. Every number, and the rows it counts.

The review is counted on the record itself, every lot in the period, and each number opens to the rows it counts. Neil drafts; QA signs.

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Line 2's product review in Seal, drafted by Neil for S. Amato, QA, at 10:30 on Thu 12 Nov: 13 lots filled from Thu 27 Aug to Fri 6 Nov, each drawn as a point for the days from its fill to its release. The four filled on paper took 28, 27, 26 and 27 days, a mean of 27; the six released on Seal took 17, 17, 15, 18, 19 and 17, a mean of 17; three wait. Five lots' fills stopped, 26-0905, 0908, 0912, 0914 and 0917, and no record counts an intervention: four were found in what was said on the line and the fifth is DEV-041. F-02's feed track rose from 1.9 to 2.6 A over five lots with no limit set. DEV-041 and CAPA-019 are open. Each number opens to the rows it was counted from, and QA signs the review.
Quality › Product review › Line 2
Drafted 10:30
S. Amato, QAThu 12 Nov, 10:30

Line 2, Aug to Nov

17 daysFill to release, from 27 on paper. Five stops nobody recorded
On paper, 27 daysOn Seal, 17 days5 stops, none recorded

Line 2's review

Aug to Nov
Neil counts from the record; QA opens each number to its rows and signsThu 27 Aug to Fri 6 Nov, a batch record each: four on paper before Seal, imported at go-live Tue 22 Sep, nine on SealFill to the QP's certificate. On paper 28, 27, 26 and 27 days; on Seal 17, 17, 15, 18, 19 and 17. 3 lots wait for their sterility result or the QPLots 26-0905, 0908, 0912, 0914 and 0917. Four found in what was said on the line; the fifth is DEV-041. Each lot's record says noneEach lot's mean while F-02 ran, 1.9 A on 26-0913 to 2.6 A on 26-0917. No limit was set on the tag until CAPA-019's 2.2 ADEV-041, the stop on 26-0917, closes with its sterility result Fri 20 Nov. CAPA-019: the new track Sat 14 Nov, then ten lots without a jam, to 26-0930Drafted 10:30 for S. Amato. Every number opens to the rows it was counted from; QA reads them and signs

Blubber Biologics is a fictional plant.

A shift is found lot by lot.

The feed track rose 0.7 A over five lots, and no limit was set. Neil draws the five means on its first night and raises it.

Explore continued process verification
F-02's stopper feed track current in Seal on Mon 9 Nov at 19:40, Neil's first night on Line 2: the mean of each of the last five lots while the filler ran, 1.9, 2.0, 2.2, 2.4 and 2.6 A on lots 26-0913 to 26-0917, Wed 14 Oct to Fri 6 Nov, drawn as five points with a line through them, rising 0.7 A. Lot 26-0917 stopped for 21 minutes at 02:08 and its record counts no intervention. No limit or alert was set on the tag. An alert at 2.2 A, drawn dashed, would have fired on lot 26-0915 at its first reading, 00:20 on Tue 27 Oct, two lots before the stop. Neil raises it to QA with the readings.
Quality › CPV › F-02 feed track
Raised 19:40
Neil, first night on Line 2Mon 9 Nov, 19:40

F-02 feed track, lot by lot

2.6 AUp 0.7 A over five lots. No limit was ever set
1.9 A2.6 A, stopped 21 minAlert at 2.2 AWould have fired on 26-0915

F-02's feed track

Five lots
Each number is a mean over the readings each lot's record keeps; QA decides what it meansF-02's stopper feed track current, read by EDGE-L2 over OPC UA: 34,800 a lot, 00:20 to 10:00, 26-0913 to 26-0917Each lot's mean while F-02 ran, 26-0913 on Wed 14 Oct to 26-0917 on Fri 6 Nov: up 0.7 A over five lots0 A from 02:08 to 02:29 on Fri 6 Nov, 2.7 A just before. Step 4.3's record has no intervention entry; the stop is left out of its meanKept since 8 Sep and never trended. Nothing fires at any value, so the rise was nobody's to seeAt its first reading, 00:20 on Tue 27 Oct, two lots before the stop. No reading of the two lots before it reaches 2.1 A. The limit is engineering's and QA's to set19:40, Mon 9 Nov, Neil's first night on Line 2. S. Amato opens DEV-041 at 08:30; its review opens CAPA-019, whose alert is 2.2 A from Sat 14 Nov

It counts what was said, too.

The records counted no interventions. Neil read what was said on Line 2 and found four jams; QA decides what each was.

Explore deviations
Line 2's interventions in Seal at 09:04 on Tue 10 Nov, in DEV-041's review, as S. Amato, QA, asks whether the stopper bowl has jammed before. The thirteen batch records since Thu 27 Aug count no intervention. Neil reads what was said on the line over the same weeks, 1,240 messages, 61 handovers and stand-ups and 9 maintenance log entries, and finds four jams, on lots 26-0905, 0908, 0912 and 0914: a shift handover on 27 Aug, a stand-up on 16 Sep, the maintenance log on 8 Oct and the line's Teams channel on 20 Oct, each with who said it. The thirteen lots are drawn as a strip of squares along the weeks, the four found in red and lot 26-0917, which is DEV-041, in ink. Whether each was a deviation is QA's to decide.
Deviations › DEV-041 › Earlier stops
4 found
S. Amato, QATue 10 Nov, 09:04

Line 2, Aug to Nov

4Stops found in what was said. Recorded as interventions: 0
26-0905DEV-041

Line 2's stops

Aug to Nov
Neil reads the records and what the line said; QA decides what each stop wasLots 26-0905 to 26-0917, Thu 27 Aug to Fri 6 Nov. Each record's intervention log is emptyLine 2's shift channel, its handovers and stand-ups, and F-02's maintenance log, Mon 17 Aug to Mon 9 NovShift handover, A. Okafor: "Bowl jammed, cleared through the glove port." Lot 26-0905's record: no interventionsLine 2 stand-up, K. Brandt: "Stoppers sticking again on nights." Lot 26-0908's record: no interventionsMaintenance log, T. Nakamura: "Freed a jam on F-02. The feed track looks worn." Lot 26-0912's record: no interventionsLine 2's Teams channel, A. Okafor: "Jammed again. Maintenance is booked." Lot 26-0914's record: no interventionsDEV-041, opened 08:30 by S. Amato, assesses the five. Neil found them; a qualified person decides what each was

Every count on the certificate adds up.

41,860 filled, 61 lost at the stop, 318 at inspection, 142 sampled, 41,339 released: every count is the record's own. The QP certifies.

Explore batch release
Lot 26-0917 in Seal at 10:12 on Mon 23 Nov, as E. Marchetti, QP, certifies it: 41,860 vials filled on Fri 6 Nov in 559 running minutes; 61 rejected at the stop, 318 at inspection, 142 sampled and retained; 41,339 released, 40,000 of them to order SO-1182. Nineteen of nineteen results in, the sterility result last on Fri 20 Nov, no growth; the fill's environmental monitoring and glove plates within limits; DEV-041 closed on Fri 20 Nov with no impact on the lot. 17 days from the fill. Each count opens to the rows it adds up from.
Batch records › Lot 26-0917 › Certificate
Certified 10:12
E. Marchetti, QPMon 23 Nov, 10:12

Lot 26-0917

41,339Released, of 41,860 filled. 17 days from the fill
Filled41,860
Rejected at the stop61
Rejected at inspection318
Sampled and retained142
Released41,339

Lot 26-0917's certificate

Filled Fri 6 Nov
Every count on the certificate is the record's own; the QP reads each and certifiesFri 6 Nov, 00:20 to 10:00, about 75 vials a minute while F-02 ran; its 21 min stop left out61 open vials between the needles and the stoppering head when the line stopped; 318 at visual inspection; 142 for release tests, retains and stabilitySterility read Fri 20 Nov by K. Sorensen, 14 days from the fill, the last of the 19. Each result against its specificationThe fill's 22 plates, settle, contact and glove, read Wed 11 Nov; the end-of-fill glove plates among themThe 21 min stop on step 4.3: 61 open vials rejected, the bulk held 29 h 40 min inside 36 h. Closed by S. Amato with the sterility resultMon 23 Nov 10:12, 17 days from the fill. 40,000 vials to SO-1182; 1,339 free to promise

Questions about APQR.

What is APQR software?

It manages the scope, population, evidence, analyses, conclusions, approvals and actions for an annual product quality review. It replaces manual compilation from separate sources, while scientific and quality review remains with your team.

Are APQR, APR and PQR the same?

They all describe a periodic evaluation of product and process quality, but the terms and detailed expectations vary by jurisdiction. Seal can be configured for the applicable scope, sections, review cycle and approvals. One template does not necessarily satisfy every market.

Can Seal collect APQR data from other systems?

Yes. Integrations can bring in manufacturing, LIMS, QMS, stability, supplier, complaint and partner records. Population completeness, late data, duplicates and source versions remain visible before approval.

How does Seal check that each batch is included?

The review definition sets an expected population and reconciles records across source systems by identity and state. Missing, excluded, rejected, reworked or pending batches need explicit handling rather than dropping out of a released-batch list.

Can APQR software calculate Cp and Cpk?

Seal can run configured statistical methods against a defined dataset, cohort, limits and exclusions. Your team decides whether a capability statistic is appropriate for the data and approves its interpretation.

How are OOS and invalidated results represented?

The full analytical history stays linked to its samples and investigations. Configured reportable-result rules decide which values enter a product statistic, while invalidated and retested results remain visible for review.

Does Seal support multi-site product reviews?

Yes. Site, process version, scale and contract party remain explicit dimensions. Reviewers can evaluate the product overall and in comparable cohorts without averaging away site or process differences.

How are prior APQR actions tracked?

Each action carries its owner, due date, source conclusion and completion evidence. Open or ineffective actions remain visible to the next review.

Can the approved report change when source data changes?

No. Approval fixes the scope, source snapshots, analyses, conclusions and signatures. Significant later information is handled through an amendment or assessment, and the next period continues separately.

How does APQR connect to continued process verification?

CPV supplies ongoing process and quality evidence. The annual review evaluates it alongside quality events, stability, complaints, suppliers and changes, and can raise new CPV actions or monitoring changes.

Can external manufacturer data be included?

Yes. Partner data keeps its source, period, batch population, receipt and review status. Missing or late partner evidence remains an explicit exception in the review.

Does it replace Spotfire, Tableau, JMP or SIMCA?

No. Process scientists explore and model in JMP, SIMCA or Spotfire, and a BI tool shows management its dashboards; each can read the record through Seal’s API. Seal counts the numbers that are themselves part of the GMP record, such as the product review, a trend against its limit and a lot’s reconciliation, where each figure has to open to the rows behind it and be signed.

Who writes the product review?

Neil drafts it from the record: the lots in the period with their yields, deviations, changes and results, each figure linked to the rows it counts. Section owners review and correct the draft, and QA approves and signs it.

Does Neil decide anything in the review?

No. Neil counts, drafts and points to what it found. Whether a trend is a shift, what an event was and what the review concludes are decided and signed by your team.

What should the first APQR implementation prove?

Take one product and reconcile its full batch population, including rejected and pending batches. Reproduce the statistics, handle missing and changed data, approve the conclusions and create the follow-up work, then check that each chart leads back to its sources.

In depth

The APQR guide7 sections

All 10 capabilities
Controlled review scope
Define the products, presentations, sites, period, population rules, sections, owners and approval before analysis begins.
Batch population reconciliation
Reconcile manufactured, released, rejected, reworked, returned and pending batches across source systems, so each batch in scope appears with its state at the data cut.
Laboratory and stability evidence
Results keep their sample, method, specification, OOS or OOT history, stability condition and timepoint.
Deviation and CAPA patterns
Group quality events by process, cause, material or equipment, and review recurrence and CAPA effectiveness in the same product context.
Supplier and material quality
Link the materials and sources actually used to incoming failures, supplier changes and complaints.
Complaints and field evidence
Connect complaints, returns, adverse events and recalls to the manufactured populations they concern.
Governed statistics
Each analysis keeps its dataset, cohort, denominator, exclusions and method version, so a chart or capability figure can be reproduced.
Change effectiveness
Compare an implemented change’s expected outcome with the batches and evidence produced after it took effect.
Evidence-backed conclusions
Each review conclusion links to the datasets and source records behind it, with its limitations and approval.
Persistent follow-up
Conclusions become CAPA, change, validation or supplier actions with owners, and their completion evidence is available to the next review.

See your process in Seal.

Working 48 hours after we agree its scope: tested, with evidence your QA approves.

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