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SPECIFICTION
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MasterControl Customer Complaints

mastercontrol.com

Web

Spec sheet

Purpose
MasterControl Customer Complaints automates and manages customer complaint processes for regulated businesses.Read 1 Oct 2026 · mastercontrol.com
Integrations
External links connect complaint handling with other computer systems, corrective actions and adverse-event handling.Read 1 Oct 2026 · mastercontrol.com
Compliance
MasterControl says the solution helps manufacturers attain and sustain compliance with ISO quality standards.Read 1 Oct 2026 · mastercontrol.com
Support
End users seeking customer support are directed to contact their system administrator, while MasterControl system administrators can log in to the support portal.Read 1 Oct 2026 · mastercontrol.com
Headquarters
Salt Lake City, Utah, United StatesRead 28 Sep 2026 · mastercontrol.com
Founded
1993Read 28 Sep 2026 · mastercontrol.com
Audit trail
It provides a secure, time-stamped audit trail documenting who created or modified electronic records, when and what changed, as required by 21 CFR Part 11.Read 1 Oct 2026 · mastercontrol.com
Automation
The software automates notifications, follow-ups and escalation of overdue assignments.Read 1 Oct 2026 · mastercontrol.com
CAPA
An optional CAPA integration can automatically escalate serious quality problems.Read 1 Oct 2026 · mastercontrol.com
MedWatch
The solution includes the FDA MedWatch 3500A form for mandatory adverse-event reporting.Read 1 Oct 2026 · mastercontrol.com
Pricing model
MasterControl says pricing is tailored to the organization and asks prospective customers to contact representatives.Read 1 Oct 2026 · mastercontrol.com
Reporting
Customizable reports cover complaint summaries, in-process complaints, categorization by type/product/department and trend analysis.Read 1 Oct 2026 · mastercontrol.com
Repository
Complaint documents are stored in a secure, centralized repository for search and retrieval during FDA inspections or ISO audits.Read 1 Oct 2026 · mastercontrol.com
Security standards
MasterControl states its platform adheres to standards including ISO 27001, ISO 27017, ISO 27701 and ISO 42001, where applicable.Read 1 Oct 2026 · mastercontrol.com
Target customers
The product is positioned for regulated companies, including pharmaceutical and other life-sciences manufacturers.Read 1 Oct 2026 · mastercontrol.com
Web access
The customer complaints suite is web-based and connects employees, customers, suppliers and other participants regardless of location.Read 1 Oct 2026 · mastercontrol.com
Workflow
A pre-configured multi-page form moves complaints through processing, internal investigation and resolution.Read 1 Oct 2026 · mastercontrol.com

Plans and prices

MasterControl solutions Priced on request pre-configured/pre-validated or flexible enterprise packages · selectable modules · named-user licensing Read 1 Oct 2026 · mastercontrol.com

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