CS Analytical Laboratory Implements Cutting Edge, cGMP, and Part 11 Compliant Quality System

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The implementation of the most advanced, custom-built, and electronic cGMP quality platform in the contract lab market positions CS Analytical above the competition in terms of quality, data integrity, and efficiency of solutions provided to the worlds’ leading drug and device manufacturers.

the only cGMP, FDA-regulated laboratory exclusively designed and built to serve container and package testing needs
The implementation of an advanced electronic quality system that meets all Part 11 compliance requirements while improving the efficiencies of the client experience has been something that I have envisioned for the past ten years

CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, officially announced today the implementation of a completely electronic quality system that meets or exceeds all relevant cGMP, 21 CFR Part 11, and FDA-issued compliance guidelines for data integrity and electronic record management. The multi-pronged system features four critical components that integrate seamlessly to provide efficiencies and data integrity across all aspects of company operations, ensuring solutions are delivered to the clients in a more efficient, transparent, and secure manner and enabling virtual audits, invaluable critical in today’s world. The custom designed and developed system spans the entire operation process, including a Client Relationship Management (CRM) system, an Electronic Laboratory Notebook (ELN), an electronic quality management system (EQMS) for document, incident, calibration, and employee training control, and the most advanced laboratory information management system (LIMS) custom built to tie these components together seamlessly. As expected, the entire system is validated to all relevant guidelines for 21 CFR Part 11 compliance.

“The implementation of an advanced electronic quality system that meets all Part 11 compliance requirements while improving the efficiencies of the client experience has been something that I have envisioned for the past ten years,” commented Sandra Cincotta, Director of Quality for CS Analytical, “and having the opportunity to develop and apply this advanced program will be something I will take much pride in.”

“This is a great example of the commitment to quality and client service that the CS Analytical team brings to the marketplace,” added Brian Mulhall, company CEO. “We are committed to bringing clients valued and much needed solutions to their container qualification concerns. This fully electronic and validated system facilitates the meeting our commitments in a more timely, efficient, and secure manner, including the option for virtual audits.”

While the use of electronic quality systems, remote networked data capture, and digital signatures are commonplace across many industries today, the FDA regulated industries continue to struggle with the complex guidelines of 21 CFR Part 11 compliance. Security and integrity of data at all levels of the drug development and manufacture process is paramount to ensuring the safety and efficacy of the drug products being brought to market. The cost for development, implementation, and ongoing maintenance of a fully validated, part 11 compliant program can be prohibitive for some organizations. Companies like CS Analytical that view quality and client service as a critical function and at the core of its corporate mission realize that hefty investment in an advanced and custom electronic quality system will set them apart from other service parties and offer a long-term return on investment.

About CS Analytical Laboratory
The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.

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