MasterControl Business Processes

QMS CAPA – Corrective Action Software / Preventive Action System Software

Because CAPA is such an extremely critical part of a quality management system (QMS), MasterControl offers three CAPA solutions to meet the varying needs of different companies.

• QMS Ready Set™ is designed to be used out-of-the-box by small, growing companies.
• QMS Custom Fit™ is for midsize to large companies that need more robust functionality to manage multiple input sources and provide additional controls. This highly tailorable solution provides unique Intelligent Forms™ that act as a virtual consultant to guide users through important processes such as risk assessment and investigation.
• QMS Total Advantage™ is the most robust CAPA system available. It includes all of the features of
• QMS Custom Fit, in addition to the ability to tie together all aspects of a company’s QMS system (document control, CAPA, training, design control, etc.). This ensures, for example, that changes to product designs, SOPs, etc., initiate new training for appropriate personnel.

Inputs to MasterControl QMS CAPA can come from any one of three sources: an event management system (where problematic events are analyzed and, if possible, resolved to reduce the number of events funneled into CAPA); specific entry points such as complaints, deviations, OOS, etc.; or a CAPA management system which collects problematic events before sending them to the company’s CAPA system.
All three solutions are Web-based, so that they can connect (from virtually anywhere) employees, vendors, customers, and anyone else who needs to be involved in CAPA. In addition, all three solutions provide tracking, email notification, escalation, time-stamped audit trails, reporting, and electronic signature capabilities.

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MasterControl Change Control – Change Management Software

This solution automates the change control process for faster turnaround. It offers a best-practice form that incorporates priority level, as well as escalations. Real-time reports provide authorized users with the status of all change control tasks. If MasterControl Training has been purchased, any change to a document/process that warrants new training will automatically send training tasks to the emails of affected employees.

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MasterControl Deviations – Deviations management software

Deviations may occur at any point: during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution. MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications.

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MasterControl Electronic Batch Records (EBR) Software

The MasterControl EBR solution automates the routing, follow-up, and escalation of batch records for more efficient process management. Pre-configured forms simplify data collection and help minimize errors. An electronic inbox tracks all active tasks and provides the tools necessary for users to stay up-to-date. The solution uses the FDA-compliant framework (or S88 standard) as the basis for modeling a wide range of manufacturing processes.

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MasterControl Equipment Calibration – Calibration Management Software

MasterControl manages the calibration schedule and automatically generates calibration tasks before due dates are reached. Detailed reporting capabilities provide insight into calibration activities and help avert bottlenecks.

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MasterControl Nonconformance – Nonconformance Management Software

MasterControl automates data collection, routing, follow-up, and escalation of nonconformance events. The electronic “in box” tracks all active tasks and provides tools for staying on top of things. This enables approvers to review and sign off on nonconformances electronically.

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MasterControl Out-of-Specification (OOS) – OOS Management Software

The Out-of-Specification (OOS) software solution from MasterControl automates OOS processes (including routing, notification, escalation, and approval) to help companies comply with FDA CGMPs and 21 CFR Part 211 regulatory requirements. Because the software is Web-based, employees, customers, and suppliers can participate in the forms-based OOS process from virtually anywhere.

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Risk Management / Risk Analysis Software

Many of MasterControl’s quality solutions include triggers for performing risk analysis. The Risk Analysis software enables a team of risk experts (designated by your company) to automatically receive information (about a deviation, for example) that triggers a risk analysis. MasterControl supplies the risk metrics, which can be further defined by your company to match specific needs. This ensures consistent, objective and defensible quality decisions.

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MasterControl Supplier Deviation – Supplier Deviation Management Software

MasterControl Supplier Deviation allows a supplier to request an exception to specification before the material is shipped. This avoids the receipt of shipments that are unacceptable to the quality department and saves a great deal of time and effort on the part of everyone involved.

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MasterControl API Toolkit – Integrate your ERP and other systems

The MasterControl API Toolkit helps companies leverage their existing systems and keep costs down by allowing them to integrate MasterControl quality applications with their enterprise resource planning (ERP), customer resource management (CRM), manufacturing execution systems (MES), and product data management (PDM) applications.

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