Key Factors


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MasterControl and the Life Sciences Industry

Life sciences companies spend an enormous amount of money in developing new products. Total investment on research for new medicines alone is estimated at about $150 billion annually. In addition, life sciences companies must contend with some of the strictest regulatory requirements today, raising the cost of doing business even more.


With more than a decade of experience in the rigorous global compliance environment, MasterControl understands that the right software solution can play an important role in optimizing an organization's GxP and other critical business processes. This helps ensure regulatory compliance, and also promotes efficient and cost-effective operations that increase a company's competitive edge. There are three key factors that distinguish MasterControl from other software providers in a strict regulatory environment:

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Using MasterControl for FDA Compliance (3:53)
Creating a Paperless Process Using MasterControl (3:38)
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White Paper: 21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?
White Paper: 21 CFR Part 11 System Validation (Risk Management Plan)
White Paper: The Future of the FDA: Operating in an "Electronic World"
Interactive and Live Demonstration: MasterControl Quality Suite Demonstration


Compliant.

Sustained Compliance: MasterControl believes that compliance is a state, not an event. The MasterControl™ GxP process and document management solution is designed not only to help companies attain compliance, but to sustain it year after year by optimizing critical business processes and fostering efficiency.


MasterControl recognizes that validating a software solution — and keeping it in a constant state of validation — is critical in maintaining compliance. MasterControl offers comprehensive validation services, including onsite, full-cycle validation. For companies performing their own validations, MasterControl offers detailed, pre-written IQ, OQ, and PQ validation test protocols and scripts. MasterControl is also actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which help lower overall validation cost.

Connected.

Integrated Business Process Management: MasterControl is integrated, effectively connecting people with data and processes for a holistic approach to document and business process management. This connectivity gives managers the "big picture" — allowing them to view and monitor all business processes to continuously improve them and to proactively reduce, if not prevent, quality problems that could lead to product recalls, returns, waste, and rework. MasterControl's integrated solutions increase efficiency, resulting in a faster process throughput and a shorter cycle time. Implementing integrated solutions also enables validation to be performed just once.

Complete.

Enterprise-wide Product Application: MasterControl believes that quality initiatives must be integrated into an organization's corporate culture. The MasterControl solution helps companies ensure that quality standards are enforced across the enterprise. Its platform is powerful enough to meet the needs of every department in an organization — R&D, clinical, quality control, regulatory affairs, manufacturing, sales and marketing, human resources, and corporate management. Its robust features enable compliance with various regulatory requirements.


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