Freedom251 › Corrective and Preventive Action Software
MasterControl CAPA
What MasterControl CAPA is
MasterControl CAPA is web software for managing corrective and preventive action in life sciences and other regulated organisations. Teams can open CAPA forms from complaints, deviations, nonconformances, audits and out-of-specification events, then investigate root causes using methods such as 5 Whys, Fishbone, 8D, FMEA and Fault Tree Analysis. The system automates routing, notifications, escalations and approvals, and includes effectiveness checks, electronic signatures and time-stamped audit trails. Integrated quality processes can initiate change control, training verification and task tracking. Analytics provide visibility for analysing CAPA data and identifying trends. MasterControl describes its quality approach as addressing FDA and ISO requirements, with controls designed for FDA 21 CFR Part 11. Its platform connects quality, manufacturing and asset management and can integrate with other business systems. The product is web-based. Pricing is on request and tailored to organisational needs; named-user licensing and available modules vary by package.
Who it suits
It suits life sciences teams and other organisations working in regulated environments that need to manage CAPA workflows and related quality processes.
What it does well
- CAPA forms can start from complaints, deviations, audits and other events.
- Root-cause methods include 5 Whys, FMEA and Fault Tree Analysis.
- Automates routing, notifications, escalations and approvals.
- Includes effectiveness checks, electronic signatures and audit trails.
- Analytics support trend identification across the CAPA process.
What to know first
- Pricing is available only on request.
- Licensing and modules vary by package.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| MasterControl CAPA | Tailored to organisation needs · named-user licensing and modules vary by package | On request |
As mastercontrol.com lists them, read 5 Oct 2026. The maker's own page has the final word.
Getting started
- Visit https://www.mastercontrol.com/uk/quality/capa-software/corrective-action-capa-software/
- Contact MasterControl representatives for pricing tailored to your organisation
- Select a package and licensing arrangement
- Use the web-based system to initiate CAPA forms
Verdict
MasterControl CAPA brings investigations, approvals and related quality workflows into a web-based system. Organisations should request a tailored quote to understand the package and licensing options for their needs.
Questions
How much does MasterControl CAPA cost?
Pricing is on request and tailored to the organisation’s needs. Licensing and modules vary by package.
What platforms does it support?
MasterControl CAPA is available on the web.
Which root-cause methods are available?
Listed methods include 5 Whys, Fishbone, 8D, FMEA, Fault Tree Analysis, Is/Is Not comparison, comparative approach, and PICCC.
Does MasterControl CAPA include electronic signatures and audit trails?
Yes. It supports electronic signatures and time-stamped audit trails. MasterControl says its process controls are designed to satisfy FDA 21 CFR Part 11 requirements.
Who is the product intended for?
MasterControl presents CAPA for life sciences and other organisations operating in regulated environments.
How is the software licensed?
The pricing page says Quality Excellence and Manufacturing Excellence use named-user licensing. Packages range from pre-configured to enterprise options.
Facts from MasterControl CAPA's own pages
- Analytics
- Visibility across the CAPA process supports data analysis and trend identification to improve quality management. · mastercontrol.com, 5 Oct 2026
- CAPA initiation
- Users can launch CAPA forms from customer complaints, deviations, nonconformances, audits and out-of-specification events. · mastercontrol.com, 5 Oct 2026
- Compliance controls
- MasterControl says its process tools include time-stamped audit trails and electronic signatures designed to satisfy FDA 21 CFR Part 11 requirements. · mastercontrol.com, 5 Oct 2026
- Headquarters
- Salt Lake City, Utah, United States · mastercontrol.com, 28 Sept 2026
- Integrations
- MasterControl describes its platform as connecting quality, manufacturing and asset management, with integrations to other critical business systems. · mastercontrol.com, 5 Oct 2026
- Intended users
- MasterControl presents CAPA as a solution for life sciences and other organisations operating in regulated environments. · mastercontrol.com, 5 Oct 2026
- Licensing and packaging
- The pricing page says Quality Excellence and Manufacturing Excellence use named-user licensing and that packages range from pre-configured to enterprise options. · mastercontrol.com, 5 Oct 2026
- Linked quality processes
- Integrated quality systems can automatically initiate change control, training verification and task tracking. · mastercontrol.com, 5 Oct 2026
- Pricing
- MasterControl asks customers to contact representatives for pricing tailored to their organisation's needs. · mastercontrol.com, 5 Oct 2026
- Purpose
- CAPA software helps life sciences organisations identify root causes of quality issues and prevent them from recurring. · mastercontrol.com, 5 Oct 2026
- Regulatory context
- The product page describes the solution as supporting a connected, compliant approach to quality management that addresses FDA and ISO requirements. · mastercontrol.com, 5 Oct 2026
- Support
- The UK product page provides a Customer Support link and lists UK sales contact details. · mastercontrol.com, 5 Oct 2026
- Workflow automation
- The system automates CAPA routing, notifications, escalations and approvals. · mastercontrol.com, 5 Oct 2026