Ten forms. One compliance posture. Zero paper.
In a GMP production environment, documentation is not a suggestion — it is the difference between passing an FDA audit and receiving a warning letter. A regulated biotechnology research facility was managing this documentation across paper binders, standalone spreadsheets, and email chains. Sample intake logs lived in one binder. Equipment calibration records lived in another. Deviation reports were handwritten and filed in folders that only one person knew how to navigate. When an inspection was announced, the team spent days assembling documentation that should have been instantly accessible. Worse, calibration due dates sometimes slipped because nobody was systematically tracking them — the reminder lived in someone’s head or on a sticky note on a lab bench.
The Lab Compliance system replaces all of that with a unified digital platform built on Domo. Ten interconnected forms cover every documentation requirement in the GMP production workflow, each backed by a dedicated AppDB collection that syncs in real time to Domo datasets. Every submission is timestamped, immutable, and immediately available for audit review. Calibration due dates surface automatically. Non-conformance events trigger resolution workflows. And the QA team has a live dashboard showing the compliance status of every piece of equipment, every active batch, and every training certification in the facility.
Benefits
This system transforms lab compliance from a paper-based retrospective exercise into a continuously updated, audit-ready digital operation.
- Inspection-ready at all times: Every piece of compliance documentation is digital, timestamped, and instantly accessible — no more multi-day scrambles to assemble binders before an FDA visit
- Immutable audit trail: Every form submission creates a permanent, timestamped record in AppDB that cannot be altered after the fact, giving auditors exactly the traceability they require
- Automated calibration tracking: Equipment calibration due dates are computed and surfaced automatically — no more missed recalibrations because the reminder was on a sticky note that fell off the bench
- Non-conformance visibility: Deviation reports flow into a structured workflow that tracks resolution status, assigned investigators, and corrective actions through completion
- Real-time training status: Every employee’s training certifications, expiration dates, and completion records are visible in a single view, ensuring the facility never operates with uncertified personnel
- Connected data model: Sample intake connects to experiment logs which connect to batch records which connect to equipment use — the entire production history is linked rather than scattered across independent documents
Problem Addressed
Regulated laboratories operate under documentation requirements that assume every action is recorded, every record is retrievable, and every piece of equipment is within its calibration window at the time of use. Paper-based systems technically satisfy these requirements — if you can find the right binder, if the handwriting is legible, if the form was actually filled out at the time of the event rather than reconstructed later, and if the calibration sticker on the equipment matches the record in the log.
In practice, paper systems create gaps that compound silently. A reagent lot gets used without being logged. An environmental monitoring reading is taken but not transcribed until the next day. A training certification expires and nobody notices for two weeks because the tracking spreadsheet was not updated. Each gap on its own is minor. Accumulated across months of production cycles, they create the kind of systemic documentation weakness that regulators are specifically trained to identify.
What the Agent Does
The system operates as a unified digital documentation platform covering the complete GMP production workflow:
- Sample intake forms: Digital capture of incoming sample metadata, chain-of-custody records, and storage condition documentation with barcode or manual entry
- Experiment logging: Structured forms for recording experimental procedures, observations, results, and deviations in real time as work is performed
- Equipment use tracking: Logs which equipment was used for which procedures, automatically verifying that calibration status was current at time of use
- Environmental monitoring: Records temperature, humidity, particulate counts, and other environmental parameters with automated out-of-range alerting
- Calibration management: Tracks calibration schedules, records calibration results, computes next-due dates, and surfaces overdue instruments before they are used
- Deviation and CAPA workflow: Structured reporting for non-conformance events with assigned investigation, root cause analysis, corrective action tracking, and closure verification
Standout Features
- Ten interconnected form types: Sample intake, experiment logging, equipment use, environmental monitoring, reagent tracking, calibration records, deviation reports, batch records, audit checklists, and training certifications — all linked through a common data model
- AppDB-to-Dataset sync: Every form submission writes to a dedicated AppDB collection that automatically syncs into Domo datasets, enabling cross-form analytics without manual data movement
- Proactive compliance alerts: Calibrations approaching due date, training certifications nearing expiration, and unresolved deviations older than their SLA all trigger automated notifications to the responsible party
- Audit-ready reporting: Pre-built compliance reports generate the exact documentation packages that FDA inspectors and GMP auditors request, organized by date range, equipment, batch, or personnel
- Offline capability: Lab personnel can submit forms from tablets in areas with intermittent connectivity, with data syncing automatically when connection is restored
Who This Agent Is For
This system is built for regulated laboratories and production facilities where compliance documentation is not optional and paper-based systems are creating risk.
- QA managers responsible for maintaining audit-ready documentation across all GMP operations
- Lab supervisors who need their teams documenting work in real time rather than reconstructing records after the fact
- Compliance officers preparing for FDA inspections who need instant access to any documentation an auditor might request
- Equipment managers tracking calibration schedules across dozens or hundreds of instruments
- Training coordinators ensuring every employee operating in the GMP environment has current certifications
Ideal for: biotechnology companies, pharmaceutical manufacturers, contract research organizations, medical device manufacturers, food production facilities, and any organization operating under FDA, GMP, GLP, or ISO quality management requirements.
