Pharma & Life Sciences

Quality documentation automation for pharma and life sciences — built around GMP, audit trails and human sign-off.

In pharma and life sciences, every batch, deviation and document change has to be recorded, reviewed and traceable. Quality teams spend much of their time assembling and checking records rather than improving quality. Automata builds automation that prepares and checks this documentation — with full audit trails and a qualified person signing off on every decision that needs one.

See Pharma & Life Sciences automations ↓ Get a price →

Batch Record Review and Release Documentation

One of the automations Pharma & Life Sciences teams ask us for most, step by step.

  1. Starts when 1

    Batch record submitted for review

  2. A Automata 2

    Pre-screen against specification

  3. A Automata 3

    Flag and categorize discrepancies

  4. Result 4

    Route to qualified human reviewer

  5. Result 5

    Document release decision

See how it works, from €799 →

How Pharma & Life Sciences organisations use Automata

Batch Record Review

Executed batch records checked against the master record, with missing entries, out-of-range values and unsigned steps flagged before QA review and release.

QA review focused on genuine issues

CAPA & Quality Incidents

Quality incidents logged, linked to their CAPAs, and tracked to closure, with overdue actions escalated automatically.

No CAPA left open past its due date

Non-Conformance Reports

Non-conformances captured, classified and routed to the right owner, with related customer complaints linked to the quality record.

Faster NCR turnaround

Document Control

SOPs and controlled documents kept on version, with review dates, approvals and training acknowledgements tracked.

Always audit-ready document sets

Cold Chain Monitoring

Temperature data monitored for excursions, with affected lots identified and the deviation workflow started automatically.

Excursions caught and documented immediately

Lot Traceability & Certification

Lot and serial traceability maintained across production and distribution, with calibration records and ISO certification evidence assembled ahead of audits.

Audit evidence ready when asked for

Built for your regulatory environment

Every automation system we build for Pharma & Life Sciences organisations includes the compliance architecture that regulated environments demand — full audit trails, human oversight checkpoints, and data handling that meets GDPR and sector-specific requirements.

EU GMP (EudraLex Volume 4) including Annex 11 for computerised systems, Good Distribution Practice, ISO 13485 for medical devices, Malta Medicines Authority requirements, GDPR.

Full audit trail on every automated decision
Human-in-the-loop checkpoints for consequential actions
GDPR-compliant data processing with EU data residency
Sector-specific regulatory expertise built in

Automations for Pharma & Life Sciences

11 ready-to-deploy automations for jobs that come up again and again in pharma & life sciences.

Batch Record Review and Release Documentation Automatically pre-screen batch records against spec before human release review, flagging deviations, missing entries, and out-of-spec results. QA & Document Review From €799 Calibration and Equipment Maintenance Record Tracking Automatically track calibration and maintenance records per instrument, flag overdue equipment, and quarantine out-of-tolerance results. QA & Document Review From €299 Cold Chain Temperature Excursion Monitoring Monitor reefer temperature data continuously and flag an excursion in real time, before a full pallet of temperature-sensitive product is written off. Logistics From €299 ISO Certification Renewal Document Preparation Automatically assemble the evidence package for ISO recertification, cross-checked against clauses and prior audit findings, ahead of the audit. QA & Document Review From €299 Linking Customer Complaints to Quality Records Automatically classify incoming complaints and link them to the matching NCR, CAPA, or batch record, surfacing product-wide patterns. QA & Document Review From €299 Management Review Meeting Documentation and Action Tracking Automatically document QMS management review inputs and decisions, and track resulting actions to closure instead of losing them after the meeting. QA & Document Review From €99 Non-Conformance Report Processing Automatically log non-conformance reports, route for disposition, and track containment and closure without losing the paper trail. QA & Document Review From €299 Patient Information Leaflet Translation Automatically translate patient information leaflets into Maltese with pharmacological terminology QA and regulatory formatting compliance checks. Maltese-Language Localization From €299 QMS Document Control Automatically enforce document control for your quality management system: version, approval routing, controlled distribution, obsolete-copy recall. QA & Document Review From €299 Quality Incident CAPA Tracking Automatically track corrective and preventive actions from a quality incident through root cause, implementation, and verified effectiveness. QA & Document Review From €299 Serial Number and Lot Traceability Tracking Track every serial and lot number from receipt to shipment automatically, so a recall or warranty trace takes minutes instead of a manual paper hunt. Inventory & Supply Chain From €299
Browse the full automation library →

Get your first Pharma & Life Sciences automation running

Pick one from the library, or describe the job. We'll confirm scope and a fixed price within one business day.

Get a price →