GMP documentation burdens
slow every batch release
Groflex brings decision execution to pharmaceutical manufacturing. Every deviation, exception, and approval is routed, documented, and audit-ready, without manual reconciliation.
Designing for GMP, GDP, and EU AI Act Article 12, not certified against any standard.
The Problem
Documentation without governance
is a liability, not a record
Manual batch record reconciliation creates compliance gaps
Operators reconcile batch records across ERP, MES, and paper logs manually. A single missed entry can trigger a deviation, delay release, or invalidate an entire lot.
Exception handling without a governed audit trail
When a deviation occurs, the decision path, who approved what, under which SOP, at what time, lives in email chains and verbal approvals. Inspectors ask for records that do not exist.
Deviation management delays compound across batches
CAPA investigations stall because the root-cause data is scattered. QA teams spend more time assembling the record than analyzing the problem. Corrections come after the next batch is already at risk.
How Groflex Works
Five steps from signal
to audit-ready record
Signal, not noise
Groflex monitors batch parameters, SOP triggers, and deviation thresholds in real time. Signals are classified before they reach a human.
- Threshold breach detection
- Cross-lot pattern recognition
- SOP trigger mapping
Every decision has a rule
Governance logic maps each signal type to the correct decision authority: QA lead, site director, or regulatory affairs, no improvisation.
- Role-based decision routing
- SOP version tracking
- Escalation path configuration
Right person, right context
The approver receives the signal, the relevant batch data, and the governance rule, not a raw alert. Decision time drops because context is already assembled.
- Contextual decision packets
- Mobile and desktop approval
- SLA-based escalation
Action with a record
When a decision is made, Groflex records the action, the approver, the time, and the data state at the moment of decision. No post-hoc reconstruction.
- Tamper-evident action log (cryptographic signing in development)
- ERP write-back available to early access partners
- CAPA initiation trigger
Audit-ready by default
Every exception, decision, and action is compiled into a structured audit package. Inspection-ready documentation without manual assembly.
- GMP-aligned record format
- Batch history export
- Inspector-ready summary view
Regulatory Context
The standards we are designing for
Designing for the standard, not certified against it.
Current Good Manufacturing Practice requires documented decision authority, deviation management, and CAPA records for every batch.
Good Distribution Practice mandates temperature excursion governance, qualified person oversight, and full distribution chain documentation.
High-risk AI systems supporting quality decisions in regulated industries must maintain human oversight and a complete audit trail of AI-assisted decisions.
Electronic records and signatures in pharmaceutical manufacturing require access controls, audit trails, and system validation documentation.
Join the early access program
We are working with a small group of pharmaceutical manufacturers to pilot decision execution for batch management and CAPA workflows. If your team faces documentation or deviation governance challenges, reach out.
No compliance claims. Designing for GMP, GDP, and EU AI Act Article 12, not certified against any standard.
One record, followed end to end.
A single counterparty concentration breach, from the moment it crosses your ceiling to the line an auditor reads back to you.
Single-counterparty concentration crossed the 70% policy ceiling on the SIN – FRA lane. Routed for approval under the standing delegation.
- Option AHold and reroute via AntwerpCost−€39,400
Holds the container and reroutes through Antwerp. Cheapest of the three, and it does not bring concentration back under the ceiling.
Residual concentration74.1%does not clear the ceiling - Option BAdvisory · recommendedSplit across two carriersCost−€11,900
Splits the volume across two carriers. Clears the ceiling at the lowest cost, and stays inside this manager's cost delegation.
Residual concentration68.2%clears the ceiling, inside cost delegation - Option CEscalate to air freightCost−€96,400
Fastest to arrive and the largest reduction in concentration. Exceeds the cost delegation, so it needs a second signature before it can move.
Residual concentration61.0%clears the ceiling, exceeds cost delegation, requires a second signature
Your decision. Not the AI’s.
See all pharma supply chain use cases.
See it in your supply chain.
Not a generic demo.
We start with your data. In 20 minutes, we will show you where your execution gap is and what it is costing you, using numbers from your own operations.
We show you the number before we sell you anything.
- Backtest01Your data · 1 to 3 days · risk-freeYour last 12 to 24 months replayed. Deleted on delivery, confirmed in writing.
- Pilot02$10,000 · 90 daysOne facility. A written outcome report against your own baseline.
20 minutes. No deck. No sales script.