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.

The challenge
Our solution

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 documents and controlled documents 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