Pharmaceutical solution
QMS for the pharmaceutical
industry
Quality system designed for GMP, EU Annex 11 and FDA 21 CFR Part 11 requirements. Deviations, validations, change control and training – digitally, auditably, in compliance.
GMP inspectors forgive no gaps in documentation
Every deviation without root cause, every overdue calibration and every missing signature is a potential audit finding. A quality system must work more reliably than paper.
System modules
Modules dedicated to the pharmaceutical industry
From production deviations through validations to management review – Ingenes Studio QMS covers every GMP requirement.
Deviations and incidents
Registration, classification (critical/major/minor), batch impact assessment, root cause analysis and corrective actions.
CAPA
Corrective and preventive actions with effectiveness verification. Linked to deviations, complaints and audits.
Validations and qualifications
Validation plans, IQ/OQ/PQ protocols, result approval, final reports and periodic reviews.
Change Control
Change management with regulatory risk assessment, QA/RA approval and implementation verification with documentation updates.
Document management
Controlled SOPs, specifications, methods – approval workflow, versioning, distribution and GMP-compliant archiving.
Training and competences
Training plans, SOP acknowledgements, automatic assignment after document change.
Batch management
Batch traceability from raw material to distribution, test results, release decision and history for each batch.
Complaints and recall
Customer and wholesaler complaint handling, market withdrawal procedure, batch recipient list and returns register.
Annex 11 / 21 CFR Part 11
Electronic records compliant with Annex 11 and 21 CFR Part 11
In pharma every change in documentation must be tracked, signed and impossible to hide. This is not an option – it is a regulatory requirement.
GMP Deviations
Deviation closed completely, not just formally
The most common GMP inspector criticism: deviations with corrective actions that do not address the true root cause.
Frequently asked questions
Questions asked by quality directors and regulatory affairs managers in the pharmaceutical industry.
Does the system support GMP work?
Yes. The system helps organize quality records, deviations, CAPA, documents, training and audits. Final process configuration depends on the procedures used by the organization.
Does the system keep change history?
Yes. Important operations can be recorded in the audit trail: who changed what and when. This supports quality record review and audit preparation.
Can the system integrate with LIMS or ERP?
Yes. The system is open to integrations with LIMS, ERP and other solutions through API, imports or agreed data exchange mechanisms. The scope is defined after reviewing the specific environment.
Do you provide validation documentation?
We do not provide ready-made customer validation documentation. We can provide technical system information and support the organization in preparing its own qualification and validation approach.
Is the system suitable for cosmetics and supplements?
Yes. The same document, CAPA, deviation, training and audit mechanisms can support organizations working under GMP, ISO 22716 or internal quality standards.
Can an auditor access the data?
Yes. You can prepare limited access to selected information or generate document and list exports for audit purposes.
Ready for a GMP-compliant quality system?
Show us your processes – we'll show you how Ingenes Studio QMS closes the gaps before your next inspection.