CS Analytical Signs IT System Support Agreement with E-2 Consulting
The CS Analytical partnership with E2 Consulting is further evidence of our commitment to ensuring that the work we perform for client meets the security and technology requirements demanded by this highly regulated marketplace
CLIFTON, N.J., April 8, 2025 /PRNewswire/ -- CS Analytical Laboratory, the world's only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container and package testing for the pharmaceutical, biotechnology, and medical device industries, is excited to announce that it has partnered with E2 IT Consulting to support the CS Analytical IT environment. Under Food and Drug Administration (FDA) guidelines, the pharmaceutical testing market is highly regulated specific to 21 CFR (Code of Federal Regulation) Part 11 rules that govern how electronic records and electronic signatures are used in the manufacture and testing process. They are critical to ensuring data integrity at all phases of a drug or medical device products life cycle to perpetually ensure patient safety.
"The CS Analytical partnership with E2 Consulting is further evidence of our commitment to ensuring that the work we perform for client meets the security and technology requirements demanded by this highly regulated marketplace," noted CS Analytical COO Brandon Zurawlow. "Going forward, these improvements in our network infrastructure provide immense benefits that are necessary in today's modern business operations, prepare CS Analytical for future global growth and expansion and most importantly, increase and ensure that risks associated with electronic data systems are non-existent on our internal platforms."
Compliance to 21 CFR Part 11 ensures that electronic records and signatures trustworthy, reliable and maintain equivalence to paper records. The key benefits to a compliant electronic network include a reduction in the risk of errors, assist in streamlining record keeping, improve overall data integrity and present a level of credibility with clients and regulators.
Key components of compliance that the CSA – E2 partnership will deliver include:
- Enhanced Implementation for controls designed to protect data
- Validation of electronic systems to ensure accuracy and reliability
- Improved use of secure and time-stamped audit trails
- Improved access parameters for authorized users
- Ensure electronic signatures include the signer's name, the date and time, and the reason for the signature
- Ensure that users have unique logins and passwords
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.
e2 IT Consulting has provided expert IT support since 2014, helping hundreds of businesses increase productivity and profitability by making IT a streamlined part of operations. Our mission is to deliver the latest technology consulting, services, maintenance, and support as a highly cost-effective IT solution in order to maximize our clients' productivity. The e2 IT Consulting team consists of Project Managers, System Analysts, Qualified Network Analysts, Network Administrators, Web Developers and Desktop Support Technicians. Clients receive years of collective knowledge in innovative IT support. Our team maintains the highest levels of technology and security certifications, so you can be confident when entrusting your organization's IT environment to us.
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SOURCE CS Analytical