The connected quality platform for pharma
21 GxP-ready modules across quality, manufacturing, lab, validation and regulatory. They connect to the systems you already run, and AI turns scattered evidence into review-ready decisions.
Trusted by life sciences leaders
Your systems stay. Your evidence finally connects.
Most plants run quality across SAP, a LIMS, an MES, shared drives and paper. CoReCo sits on top as one governed layer, so every record, signature and decision is linked and traceable.
Your existing systemsKept as the system of record
CoReCo quality platformBuilt into every module
4 solution suitesStart with one, add more
21 modules. One quality system.
Every module shares the same data, workflows and audit trail. A deviation raised on the shop floor can reach CAPA, change control, training and your APQR without anyone re-keying it.
A complete eQMS aligned to ICH Q10, 21 CFR 211 and revised Schedule M, covering the full cycle from quality event to verified closure.
Document Control
Author, review, approve and distribute SOPs with version control, effective dates and read-and-understood tracking.
Training & Qualification
Role-based curricula assigned automatically on every SOP revision. Qualification status controls who can perform a task.
Deviations & Quality Events
One intake for deviations, nonconformances and lab exceptions, with risk classification and batch impact assessment.
Investigations & RCA
Phase I and II lab investigations and guided root-cause analysis. AI assembles the evidence timeline.
CAPA Management
Closed-loop CAPA with effectiveness checks, recurrence monitoring and independent QA closure.
Change Control
Assess impact on documents, training, equipment and validation before any change is approved.
Complaints & Recall
From market complaint intake to batch-level recall, with reportability assessment and reconciliation.
Audit Management
Plan internal, supplier and regulatory audits. Track every observation through CAPA to verified closure.
Quality Risk Management
ICH Q9(R1) risk registers, FMEA scoring and periodic review, linked to changes and CAPAs.
Supplier & CMO Quality
Qualify vendors, CMOs and contract labs. Manage quality agreements, scorecards and supplier CAPAs.
Need the complete eQMS?
All 10 modules share one record, so an event moves from intake to CAPA, change control and training without a single re-key.
Plan my eQMS rollout →Paperless records on the shop floor and in the QC lab, with ALCOA+ data integrity and direct links to your MES, SCADA and instruments.
Batch Record Review & Release
Review by exception across MES and paper records, so QA can release batches in hours instead of days.
eLogbook
ALCOA+ equipment, area and cleaning logs on tablets, replacing paper registers on the shop floor.
Equipment, Calibration & Maintenance
One asset register with calibration, preventive maintenance, qualification status and restricted-use controls.
Product, Material & Spec Master
A single governed source for products, materials, specifications and methods across sites and markets.
QC Lab Management
Samples, specifications, results, stability and environmental monitoring, with instrument integration.
Connected to your shop floor
Pull live data from MES, SCADA/PLC and lab instruments, so batch records, logbooks and QC results feed straight into investigations and APQR.
Talk to a manufacturing specialist →AI that reads across every system and returns answers with citations. A named reviewer approves every output before it counts.
Dossiera: Regulatory Dossier AI
Curates CTD content, maps regional differences and drafts deficiency responses, each traced to its source.
See Dossiera below ↓Annual Product Quality Review
Compiles batch, deviation, OOS, CAPA, complaint and stability data into a review-ready APQR.
Continued Process Verification
Continuous monitoring of CPPs and CQAs with SPC charts, capability indices and drift alerts.
Quality Metrics & Management Review
A live KPI library and ready-made management review packs, with every figure traced to its source.
Keep systems in a validated state and prove data integrity at inspection, without a warehouse of binders.
Validation Lifecycle Management
Paperless URS, risk assessments, IQ/OQ/PQ protocols and traceability matrices, aligned to GAMP 5.
Audit Trail Review & Access Governance
Audit-trail review by exception, plus periodic access reviews with segregation-of-duties checks.
Validation package included
Every CoReCo deployment ships with URS, risk assessment, IQ/OQ/PQ protocols and a traceability matrix, ready for your QA sign-off.
See a sample package →File in more markets with one source of truth
Regulatory dossier authoring with full traceability. One product, dozens of markets and thousands of source documents: Dossiera reads them all and shows exactly where each claim comes from and how every region differs.
- Source-linked CTD contentEvery statement traces back to the study, batch or specification it came from.
- Regional variance mappingSee what differs between your EU, US, Brazil and GCC filings in one view.
- Deficiency response draftingAI drafts answers to agency queries, with the supporting evidence attached.
- Human sign-off at every gateReviewers accept or reject each suggestion, and the audit trail records both.
One OOS result. Six modules. Zero re-keying.
Here's what happens when a dissolution test fails, and why it matters that every module shares one record.
OOS flagged
A dissolution result fails spec in the LIMS and opens an event automatically.
Root cause found
AI gathers batch, equipment and analyst history. QA confirms the cause.
Action agreed
A CAPA is raised with an effectiveness check due in 90 days.
SOP revised
Change control updates the SOP, and retraining goes to affected analysts.
Trend captured
The event and CAPA appear in the year's APQR, fully cited.
Filings checked
Dossiera flags every market filing that references the changed method.
Results from our pharma programmes
From first workshop to validated go-live
One team, from process design through validation. You get working software, the qualification package and measured results.
Assess
- Map current processes and systems
- Baseline cycle times and effort
- Agree scope and success KPIs
Configure
- Configure workflows to your SOPs
- Connect ERP, LIMS and MES
- Migrate legacy records
Validate
- URS, risk assessment and trace matrix
- IQ / OQ / PQ execution
- Validation summary report
Go live & measure
- Train users and support go-live
- Track adoption and KPIs
- Quarterly value reviews
We don't just deliver software.
We ensure results.
Many vendors build to the spec, hand over and move on. We walk with you every step of the way, from the first workshop to measurable results.
We start with your people, not a spec
We sit with your QA, QC, regulatory and plant teams to understand how work really gets done: the workflows, the frustrations and the blockers. Only then do we propose a solution.
Customised to how you work
Workflows, screens and reports are shaped around your SOPs and your team's preferences, and connected to the systems you already run.
Accountable for outcomes, not just delivery
We take responsibility for the KPIs you care about: how many employees adopt the new process, and the hours saved, costs cut or margin gained. We measure and review them with you.
Hand in hand, long after go-live
The same team stays with you after launch, responds quickly and plans improvements with you as your needs change.
- Delivers to the SOW, then steps back
- Success means features shipped to spec
- Every change starts a new negotiation
- Support through a ticket queue
- Stays involved until the outcomes land
- Success means adoption, time and cost saved
- Enhancements planned together as needs evolve
- A dedicated team that knows your plant
Real problems, real outcomes
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Automated reseller training and licence provisioning across commerce and learning systems.
AI-Ready Safety Data Sheets
A secure, audit-ready platform for safety data sheet creation, control and retrieval.
Guides for pharma and life sciences leaders
Practical, no-cost playbooks from our consulting team.
Free guideFrom AI Pilots to Scalable Value: Pharma & MedTech
A practical guide to scaling AI from pilot to production in pharma and MedTech.
Download now →
Free guide5 Bottlenecks that Cost You Millions
Five common operational bottlenecks and practical approaches for removing them.
Download now →
Free guideList of 10 AI Use Cases
Ten practical AI use cases for shaping a focused enterprise AI roadmap.
Download now →
Do we have to replace our existing QMS, LIMS or MES?
No. CoReCo connects to your existing systems and keeps them as the system of record where you want that. You can adopt one module, a full suite or the complete platform.
Is the platform 21 CFR Part 11 and EU Annex 11 compliant?
Yes. Electronic signatures, immutable audit trails, role-based access and record retention are built into the platform and inherited by every module.
Who validates the system?
We deliver a GAMP 5, risk-based validation package: URS, risk assessment, IQ/OQ/PQ protocols, a traceability matrix and a summary report. Your QA team reviews and approves it.
How is AI controlled in a GxP environment?
Every AI output cites its sources, is versioned, and must be accepted by a named reviewer before it becomes part of a record. The audit trail captures both the suggestion and the decision.
Can it run on-premise?
Yes. Deploy on-premise, in your private cloud or as managed SaaS. AI models can run inside your network, so data never leaves your environment.
How long does implementation take?
A single-module pilot is typically live in about 30 days. A multi-module rollout at one site usually takes 3 to 6 months, including validation.
See the platform on your own process
Tell us which module matters most. We'll show you a working demo configured to a real workflow from your plant.