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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.

Matrix Quality
The challenge
Our solution

GxP compliance across development, manufacturing, and distribution is complex to manage

A GxP-validated quality platform built for pharma and biotech

  • Multiple GxP frameworks, one quality system

    • GMP, GCP, GLP, and GDP each have specific documentation and process requirements. Managing all of them in disconnected systems creates gaps and inconsistencies.

  • GMP, GCP, and GLP workflows in one system

    • Matrix Quality supports the full range of GxP quality processes — deviation management, CAPA, document control, training, and batch records — in a single validated platform.

  • Validation is a constant obligation

    • Every computerised system used in a GxP environment must be validated. Without built-in validation support, this is a significant ongoing cost.

  • Built-in validation support

    • Validation 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.

  • Regulatory inspections require rapid evidence retrieval

    • FDA and EMA inspectors expect immediate access to training records, deviations, batch records, and CAPAs. Manual systems cannot deliver this.

  • Inspection-ready at all times

    • Every quality record is version-controlled, user-attributed, and timestamped. Evidence retrieval for FDA or EMA inspections takes minutes, not days.

    The challenge

    GxP compliance across development, manufacturing, and distribution is complex to manage

  • Multiple GxP frameworks, one quality system

    • GMP, 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 obligation

    • Every 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 retrieval

    • FDA 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 system

    • Matrix 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 support

    • Validation 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 times

    • Every 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 managementLog, 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 documentationElectronic 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 managementManage 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 managementQualify 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

    Roche

    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

    Matrix One is trusted by 500+ Life Sciences & Medical Device Companies