CSSC Selected as Testing Laboratory Accreditor by SAFE-BioPharma Association
CSSC, a regulatory compliance and validation company, announced today that SAFE-BioPharma Association has selected CSSC as the accreditation agent for testing laboratories that will offer SAFE certification testing to application vendors who operate in the biopharmaceutical industry space.
To ensure that testing is objective and meets the requirements of the SAFE Product Certification Program (SPCP), SAFE-BioPharma has developed the SAFE Laboratory Accreditation Program (S-LAP) and chosen CSSC as the independent third party SAFE accreditation agent. In this role, CSSC will ensure that selected laboratories, upon entry into the program, meet the stated requirements of the S-LAP Specification, and that they continue to meet these requirements going forward. CSSC has developed an audit standard which evaluates SAFE testing laboratory applicants in 20 areas of technical and quality system compliance.
“CSSC was selected due to our leadership in regulatory compliance, auditing, and developing issues in the pharmaceutical industry,” said Raymond A. Roggero, President and Chief Operating Officer, CSSC.
CSSC provides comprehensive global services to help pharmaceutical, medical device and biotech companies stay compliant in a challenging regulatory environment. CSSC has a long and successful history of providing regulatory compliance solutions to pharmaceutical firms.
“SAFE enables industry interoperability and integration that until now has been too complex and cost prohibitive,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association. “Our partnership with CSSC will help the vendor community to SAFE-enable and certify their products.”
SAFE-BioPharma Association manages and maintains the SAFE (Signatures and Authentication for Everyone) digital identity standard that facilitates legally enforceable, paperless transactions. The SAFE digital identity was created to provide a consistent and industry-wide method for managing and utilizing digital signature. It is designed to be used for all electronic business-to-business and business-to-regulatory healthcare transactions.
CSSC maintains its operations according to the principals of ISO 9001. CSSC has a comprehensive quality system including a Quality Manual, a Quality Policy, Quality System Processes and Standard Operating Procedures. All employees undergo extensive training in their area of expertise, as well as in overall quality assurance and project management. All CSSC deliverables undergo review by its internal Quality Organization. This proven system for managing compliance projects is unique to CSSC and a cornerstone of their service. Decades of validation experience combined with a structured quality review and project management ensure that all projects are completed on schedule, on budget and with high quality.
“We see this as verification of our auditing capabilities and leadership in compliance consulting,” said Jeff Boatman, CSSC Director of Quality.
About CSSC, Inc.
CSSC, Inc., headquartered in Morristown, New Jersey, provides full-service regulatory compliance services and consulting. CSSC has more than 80 employees in 3 locations in the United States and a strategic partnership in Europe to service worldwide clients. Founded in 1994, CSSC offers a complete range of compliance solutions to the pharmaceutical, biotechnology, and medical device industries, including comprehensive validation services, project management, Quality System Regulation consulting, 21 CFR Part 11 services, PDMA compliance solutions, auditing, and training. CSSC scientists, engineers, and project management professionals are respected throughout the industry for their knowledge and experience. For more information, visit www.csscinc.net .
About SAFE
SAFE ( www.safe-biopharma.org ) is an integral component of the global eHealth movement. The SAFE digital identity, which facilitates both strong authentication and the creation of digital signatures, has been standardized with the specific goal of achieving interoperability in a secure and trusted environment. SAFE digital signatures are being used in business-to-business and business-to-regulator transactions. SAFE signatures are legally enforceable and regulatory compliant.
