Digitalize your validation processes, document management, and audit trails for permanent GMP compliance.
Request a free diagnostic →Between regulatory pressure (GMP, FDA, EMA), the complexity of validation processes, and still largely manual document management, quality teams are under constant strain.
Complex GMP document lifecycle, permanent non-compliance risk.
Time-consuming IQ/OQ/PQ protocols that are difficult to keep up to date.
Reconstructing an audit trail for ANSM is a risky and stressful exercise.
Facing ANSM requirements, batch genealogy remains incomplete and difficult to reconstruct.
Custom SaaS solutions and consultants embedded in your teams
Creation, review, approval, archiving — automatic and compliant versioning.
Digital IQ/OQ/PQ protocols. Real-time deviation and CAPA tracking.
Every action traced, timestamped, and electronically signed. 21 CFR Part 11 compliant.
From active ingredient to finished product: genealogy, storage conditions, release.
Free assessment of your pharmaceutical processes
Request a diagnostic →Quality teams spend considerable time maintaining GMP compliance manually. Our platform automates regulatory tracking, batch record management, and inspection preparation for effortless continuous compliance.
Mapping of existing processes, identification of GMP gaps, and prioritization of corrective actions
1 to 2 weeksTechnical architecture, functional mockups, batch record pilot on a limited scope, and validation
2 to 4 weeksIterative development: batch records, deviations, CAPA, change control, GxP document management, and audit trail
8 to 16 weeksCSV/GAMP 5 validation, production deployment, team training, and ongoing support
OngoingThe EU FMD directive requires end-to-end serialization. We develop track & trace systems that connect every step of the chain — from raw material to patient — with full traceability and guaranteed NMVS/EMVS compliance.
Computerized systems validation is an essential regulatory prerequisite. We structure and automate the entire qualification cycle — from installation to performance — according to GAMP 5 frameworks and inspector expectations.
URS, risk analysis, validation plan
Infrastructure, configuration, and access verification
Functional tests, boundary scenarios, audit trail
Real conditions, load, performance, robustness
Periodic reviews, change control, requalification
Pharmaceutical quality goes beyond document compliance. We digitalize the entire quality system — CAPA, complaints, product quality reviews, and pharmacovigilance — for total risk control and continuous improvement.
Deep knowledge of the pharmaceutical technology ecosystem, gained through hands-on experience alongside quality, production, and IT teams.
Laboratory analysis management, results, and certificates of analysis
Electronic batch records, manufacturing tracking, and yield
Deviations, CAPA, change control, and quality reviews
EU FMD, aggregation, NMVS/EMVS, and track & trace
Production management, purchasing, inventory, and planning
RAD, dashboards, workflows, and integrations
Quality documents, SOPs, protocols, and reports
GAMP 5, qualification, IQ/OQ/PQ, and audit trail
Before/after comparison on key processes of a pharmaceutical site.
If you check 3 of these 5 warning signs, it's time to take action.
Yes. The platform natively integrates electronic signatures, timestamped audit trails, and document versioning in compliance with 21 CFR Part 11 and GMP requirements.
We provide IQ/OQ/PQ protocols and support your quality team through validation. Validation documentation is generated automatically.
Yes. We perform integrations with leading LIMS, pharma ERP, and document management systems via REST API or dedicated connectors.
The pilot starts within 4 to 8 weeks. Full compliance is achieved in 36 to 48 weeks, including validation and team training.
Free audit of your processes within 48 hours. Our experts analyze your needs and propose a tailored solution.
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