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The strategic goals of most manufacturing companies are to manufacture competitive products, operate profitably and grow their business in an environment
of increasing globalization and elevated product development costs. This is challenging enough in itself, but for Medical Device and
Biotech Manufacturers,
the task is even more daunting due to the additional burden of dealing with the various facets of
compliance in manufacturing originating from the FDA, EPA
and SEC among others.
The core mandate that guides FDA regulatory oversight is consumer safety. As a result, the FDA has defined current Good Manufacturing Practices for
both device and drug manufacturers that dictate the necessary measures that must be taken to ensure that quality systems and processes are in place to
consistently produce quality products. As a result, manufacturers seek to attain a manufacturing
certificate of compliance.
The goal of meeting the challenge of manufacturing regulatory compliance is the establishment of a consistent “top down” strategy for ensuring
compliance across the manufacturing enterprise. Camstar has responded to this need by creating computer software for manufacturing regulatory compliance
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Enterprise Manufacturing Execution and Quality Systems that satisfy the needs of Medical Device and Biotechnology manufacturers for a comprehensive
compliance solution.
Fully 21 CFR Part 11 compliant, Camstar’s Manufacturing Execution and Quality System, InSite, provides the comprehensive enterprise technology
infrastructure manufacturers need to maintain regulatory compliance while dramatically reducing its associated costs and risks. InSite enables
manufacturing business process automation by creating a paperless environment for the establishment, maintenance and management of regulatory
compliant global manufacturing operations. InSite allows companies to more easily and cost-effectively maintain
compliance with good manufacturing practices.
Establishing InSite as the manufacturing regulatory compliance software platform brings additional benefits. Real-time production data can be analyzed so that
adverse trends can be proactively acted upon before they become product/process quality issues. By capturing production data, analyzing it against performance
metrics, alerting on trends and insuring early “closed-loop” preventative action, Life Sciences Manufacturers are able to leverage their investment in computer software
for manufacturing regulatory compliance. By establishing a Manufacturing Execution System for manufacturing regulator compliance, they directly drive
organizational behavior in accordance with strategic goals.
As the core application around which manufacturing compliance is established, InSite provides a set of functionality that spans FDA
regulatory requirements. InSite is an Enterprise Manufacturing Execution System that delivers the live visibility and control necessary
to optimize production processes across multiple unique manufacturing sites.
Learn more about how Camstar customers successfully implement a comprehensive
compliance solution using InSite Manufacturing Execution and Quality System.
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