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 — built on Salesforce with full 21 CFR Part 11 and EU Annex 11 compliance.
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 the full range of GxP quality processes — deviation management, CAPA, document control, training, and batch records — in a single validated platform.
- 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
Batch record documentation
Electronic batch records with full material traceability, in-process controls, and QC release — aligned to GMP requirements.
Electronic batch record management
Material and lot traceability
QC release with e-signatures and audit trail
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
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
