Batch Review by Exception

Start the review where it matters — not on page 1.

Paste a batch package and ComplianceWorxs reads it the way an experienced QA reviewer does: it finds the deviations, OOS results, excursions, missing verifications, and qualification gaps, clusters the related ones into investigation threads, and ranks them so you open the highest-risk item first. It directs your attention. It never decides disposition.

A batch production record — deviations, results, and trend charts — with the key exceptions surfaced first for review.
01

Paste the package

Drop in the batch record and its supporting documents — deviations, OOS investigations, EM data, training, lab results. Page markers like [p.183] are read and reported back.

02

The engine ranks the exceptions

It locates every exception, anchors each to the text it found, merges related records into single review threads, and orders them by where a good reviewer would look first.

03

You work the console

A reviewer attention map: start-here item, ranked queue, the evidence located and not located for each, and a clear read on what stands between the batch and a release decision.

Batch package text

Works with: ✓ Batch records✓ Deviations✓ OOS investigations✓ Environmental monitoring✓ Training records✓ Change controls

Sample output — this is what you get

5
Review areas
3
High attention
1
Missing docs
No
Release ready

Start here

Release decision at risk High priority

A deviation closed as “No Impact” involved an operator whose qualification had expired at the time of manufacture.

The batch remained within the validated blend range (25–45 minutes).

The release decision depends on whether the qualification lapse was correctly determined to be non-causal.

Evidence located in the submitted material

  • DEV-117 · p.54 — “blend time reached 42 minutes”
  • TRN-001 · p.88 — “BLD-204 status: expired”

Evidence not located in the submitted material

  • Approved blend-time range — not located in the submitted material
  • Basis for the “no impact” closure — not located in the submitted material
  • Assessment that the qualification lapse was non-causal — not located
Question the reviewer must answer

Was the qualification lapse merely associated with the event, or a contributing factor?

Every point is anchored to the text it came from, and what is absent is named — scoped to what was submitted. It directs the review; it never decides disposition.

What you get

  • A reviewer attention map — every exception found, ranked so the highest-risk item is first.
  • Evidence located — each finding tied to the exact line that triggered it, quoted from your package.
  • Evidence not located — what an inspector would expect and the submission does not contain, named before the inspection does.
  • Clustered findings — related records (a deviation and the expired training behind it) merged into one review thread, not scattered rows.
  • Decision readiness — what is still outstanding before a release decision, and a route to capture that decision as an Authorization Record.

Security & data handling

  • Encrypted in transit. The page is served over HTTPS, so your text travels over a TLS-encrypted connection.
  • Not stored or logged. Your text is processed in memory to generate the review and returned — it is not written to a database or persisted.
  • Not read by staff. The review is fully automated. No ComplianceWorxs personnel read your submissions.
  • Not used to train AI models. Content processed through our AI provider's API is not used to train models.
  • You stay in control. De-identify your package before submitting; you remain responsible for what you upload.
Disclaimer & terms of use

ComplianceWorxs Batch Review by Exception is a review-support tool. It locates, clusters, and ranks items in a batch package that warrant a reviewer's attention. It does not determine batch disposition, does not recommend release or rejection, and does not make GMP, regulatory, or quality decisions. A missed exception is possible; this output is the starting point for review, never a substitute for complete review by a qualified person. Output is generated by an automated system and must be verified against the source records. The reviewer and their organization remain solely responsible for all disposition decisions and regulatory compliance. By using this form you confirm you are authorized to submit the content and accept these terms. Governing law: Commonwealth of Massachusetts.