APQR in a day, not a month.
Six specialised agents pull from TrackWise, JMP, ERP, and SharePoint, then compile a formal APQR document with per-paragraph provenance. 1 month → 1 day. 90% time reduction per product. Auditor can trace any sentence back to its source record.
Manual APQR is the most expensive paperwork in pharma.
A senior quality engineer spends 3–6 weeks per product gathering data from TrackWise, MES, ERP, stability databases, complaint systems, and SharePoint — then writes a 60-page document by hand. Multiply across a hundred products. Compound across years.
Fragmented source data
Deviations live in TrackWise. Batches live in MES. Stability lives in JMP. Complaints live in a CRM. Each system has its own export format and login flow.
Cut-and-paste authoring
SMEs paste exports into Word, hand-format charts, and write narratives from scratch. Different SMEs produce different reports for similar products.
No provenance once compiled
When the auditor asks "where did this number come from?", the answer is an email chain. The link from final document to source record is broken.
A specialised agent for each upstream system.
Each agent is purpose-built for one of your upstream systems — its data shape, its quirks, its vocabulary. The Document Authoring Agent then composes the final APQR with per-paragraph references back to the source.
Deviations & CAPA Agent
Pulls Deviation, CAPA, and Effectiveness Review records from TrackWise. Classifies by severity, tags trends, drafts the APQR Section narrative.
Batch & Yield Agent
Reads batch records from MES/ERP. Calculates yield, batches-released, batches-rejected. Produces trend graphs ready for inclusion.
Complaint Trend Agent
Aggregates complaints by product family, harm class, and regulatory category. Cross-references against historical baselines.
Stability Agent
Reads stability study data (JMP, internal apps). Highlights out-of-trend points. Flags upcoming shelf-life decisions.
Change Control Agent
Lists every change control event affecting the product in the review period. Categorises by impact and traces approvals.
Document Authoring Agent
Compiles the formal APQR document from the upstream agents' outputs. Per-section provenance — every paragraph traceable to source.
A platform behind every paragraph.
Each agent is grounded in your business vocabulary and runs inside the same engine that powers every other CLAiRE appliance. Every paragraph in the final document traces back to a source record.
Each agent reasons over your real controls, deviations, CAPAs, and batches — not generic terminology it borrowed from the internet.
Every agent emits answers in a schema you can rely on. Malformed output is caught and retried before it reaches the next step.
The Document Authoring Agent records the source records behind every claim. The final APQR ships with an evidence pack so the auditor can trace any sentence to its source.
Each agent keeps a working notepad for hypotheses and partial findings during the run — discarded when the task ends unless you keep what it found.
Each agent has a curated set of golden test cases. When the agent changes, the platform reruns the whole library to show you what moved.
Bad prompts are filtered at the input. Tools are constrained at the agent. Sensitive data is filtered on tool results. The final document is post-filtered before anyone sees it.
Compile APQRs at the speed of your portfolio, not your headcount.
APQR ships as an appliance — connects to your existing systems, runs in your tenant, produces a formal document plus an evidence pack ready for inspection.