One Integrated Platform for All Pharmaceutical Quality Processes

MasterControl enables you to more easily maintain compliance efficiently and affordably. Our closed-loop methodology ensures that all required activities are completed quickly and that information is always up to date. MasterControl gives you the confidence you need when an auditor or inspector knocks on your door.

The Top 5 Trends in Pharma

One Integrated Platform

01

Device Documents & Records

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MasterControl Device Document Control Software

MasterControl Documents saves time and money by efficiently automating the routing, delivery, escalation, and approval of documents, making it easier for search and retrieval during inspections and audits.

02

Audits & Observations

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MasterControl Audit Management Software Systems

MasterControl Audit process management software, an integrated part of the MasterControl quality management suite, automates and manages medical device audit management systems in an efficient and cost-effective manner.

03

Change & Release

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MasterControl Change Control

MasterControl Change Control effectively manages change by automating every step of the change control process, from submission through actual implementation, verification, and close of a project.

04

Risks & Mitigations

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MasterControl Risk

MasterControl Risk integrates risk management throughout all quality processes to minimize risk by unifying all risk-related activities and documentation in a single, centralized repository. It improves decision making and ensures quality by providing an accurate picture of the risk landscape across product lines, business processes, and business units, precluding reputation damage from recalls or regulatory action.

05

Suppliers & Supplied Materials

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Suppliers & Supplied Materials

MasterControl Supplier helps ensure higher product quality by managing supplier quality processes (such as a conforming material report or a approved vendor list) in a single location for accessing all documentation and records related to each supplier.

06

Quality Events & CAPA

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MasterControl Corrective Action Software

MasterControl Corrective Action software is a robust, easy-to-use system designed to effectively manage the corrective action / preventive action process and integrate it with other quality processes critical to regulatory compliance, such as change control, audit, and customer complaints.

Why Pharmaceutical Quality Managers Like You Choose MasterControl

The week before the Christmas holiday, the FDA walked in our door we had no issues with our document control and training management processes.

Matthew Hildebrand - Director, Regulatory Affairs - Contract Pharmacal Corp

What used to take us two to three weeks to get a change control through the system, we now can get through in just one day.

Jeff Robinson - V.P. Quality Operations and Regulatory Affairs - AMPAC Fine Chemicals

(MasterControl) really assisted everyone from the chemist in the laboratory to senior management in being able to access information and collate it for a given objective.

Patrick DeVillier - Senior Director of Compliance - A.P. Pharma

Top 5 Clinical Trends in Pharma and Biologics

The clinical world is abuzz with speculation and concerns about prospective regulatory changes, drug pricing dilemmas, revolutionary therapies, and technological advancements. Scientific, economic, policy, and technological changes occur so rapidly and often in life sciences that biologics and pharmaceutical companies must be visionary and adaptable to simply exist, let alone prosper.

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