Quality management & SPC · MasterControl

MasterControl

Cloud QMS for life sciences and other regulated manufacturers, covering quality events, documents, and compliance.

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MasterControl provides cloud-based quality and manufacturing software aimed primarily at life-sciences and other regulated manufacturers pursuing FDA, EMA, GxP, and ISO compliance. Its Quality Excellence suite manages quality events such as deviations, complaints, and CAPAs, document control, training, and audits, and includes an AI feature (GxPAssist) intended to speed investigation and event-resolution work, alongside built-in business-intelligence dashboards for quality metrics. Like ETQ Reliance and TrackWise, MasterControl is a quality-management-system platform that governs the processes and records around manufacturing quality rather than a statistical process control tool that charts live process measurements; teams typically pair it with SPC software such as InfinityQS or SIMCA for the shop-floor charting itself. MasterControl reports use by more than 1,100 companies worldwide and positions itself specifically toward the compliance and validation demands of pharmaceutical, biotech, and medical device manufacturers.

At a glance

Vendor MasterControl
Pricing model Quote only
Free tier No
Deployment Cloud
Open source No
Best for Life-sciences and regulated manufacturers needing a validated, GxP-focused quality management system.

Pricing

Priced per user/module through direct negotiation with MasterControl; no public price list.

Pricing has not been verified yet — see the vendor's site.

Features

  • Quality event management (deviations, complaints, CAPA)
  • Document control and training management
  • Audit management
  • GxPAssist AI-assisted investigations
  • Built-in quality business-intelligence dashboards
  • Calibration management
  • ISO 13485 and FDA/EMA compliance support

Profile last reviewed September 21, 2026

Head to head

Alternatives

ETQ Reliance Cloud eQMS covering document control, CAPA, audits, and supplier quality with no-code workflow configuration. TrackWise Long-established QMS for life sciences, available on-premises or as TrackWise Digital, managing CAPA and compliance. InfinityQS SPC software that charts manufacturing process data in real time to catch defects and process drift on the shop floor.

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Terms to know

Data governance The policies, roles and processes that determine how data is defined, owned, accessed and kept compliant. Statistical process control (SPC) Using control charts and statistical limits to tell normal process variation apart from a genuine problem in real time.

Related guides

How to choose a quality management system Decide first whether you need to manage quality paperwork, chart live process data, or model multivariate batch data — three separate jobs.