Matrix Quality for Pharmaceutical and Biotech
Pharma and biotech companies must operate under strict GxP requirements across development, manufacturing, and distribution. Matrix Quality supports GMP, GCP, and GLP workflows in a single validated platform, with 21 CFR Part 11 and EU Annex 11 compliance and validation following GAMP 5.
For taking a demo with our team.
The challenge
GxP compliance across development, manufacturing, and distribution is complex to manage
- Multiple GxP frameworks, one quality systemGMP, GCP, GLP, and GDP each have specific documentation and process requirements. Managing all of them in disconnected systems creates gaps and inconsistencies.
- Validation is a constant obligationEvery computerised system used in a GxP environment must be validated. Without built-in validation support, this is a significant ongoing cost.
- Regulatory inspections require rapid evidence retrievalFDA and EMA inspectors expect immediate access to training records, deviations, batch records, and CAPAs. Manual systems cannot deliver this.
Our solution
A GxP-validated quality platform built for pharma and biotech
- GMP, GCP, and GLP workflows in one systemMatrix Quality supports GxP quality processes in a single validated platform: deviations handled as quality events that feed CAPA, document control, training, change control and supplier management.
- Built-in validation supportValidation documentation is prepared by the system. Test scripts are executed electronically with full audit trail, aligned to 21 CFR Part 11 and EU Annex 11.
- Inspection-ready at all timesEvery quality record is version-controlled, user-attributed, and timestamped. Evidence retrieval for FDA or EMA inspections takes minutes, not days.
Common workflows
Quality processes for pharmaceutical and biotech companies.
Deviation and CAPA management
Log, investigate, and resolve deviations with structured workflows for root cause analysis, corrective actions, and preventive measures.
Deviation classification and investigation
CAPA assignment and closure tracking
Full audit trail and regulatory reporting
Integrated change control
Assess the impact of each change and route it for approval, with electronic signatures and an audit trail on every record.
Change impact assessments
Approval workflows with electronic signatures
Audit trail on every record
Controlled document management
Manage SOPs, protocols, specifications, and standard forms with controlled review, approval, versioning, and training links, aligned to GMP documentation requirements.
Controlled review and approval workflows
Version control with full change history
Links to training requirements on document update
Supplier management
Qualify API suppliers, excipient suppliers, and contract manufacturers with structured workflows, audits, and direct supplier portal access for collaborative management.
Supplier qualification and approval
Audit scheduling and finding management
Supplier portal for SCARs and questionnaires
Watch: best QMS software for pharma, biotech and CDMOs in 2026
Matrix Quality first, then Veeva Vault QMS, MasterControl, Qualio, Scilife, ETQ Reliance and ComplianceQuest.
Hear from our customers
Matrix Quality gives us a single, validated system for our entire quality process. Audits that used to take weeks of preparation now take days.
Quality Director, Life Sciences Company
