CSSC Recently Completed Successful Siebel Systems Validations for Three Major Pharmaceutical Companies
CSSC, the leading regulatory compliance and validation company for the PDMA regulated industry, announced today that it has recently completed successful Siebel ePharma System validations for three major pharmaceutical companies. Two of the validations, Siebel versions 7.7 and 7.8, included front end practitioner signature capture and the other, Siebel 7.8, included both front end signature capture and back end sample accountability. In addition to having validated the core ePharma application, CSSC has validated custom functionality, reporting tools and contact center. During the course of the projects, CSSC provided valuable input during intense JAD sessions including PDMA/DEA and Part 11 guidance.
From six offices in the United States, a Singapore office and a strategic partnership in Europe, CSSC provides comprehensive global services to help pharmaceutical, medical device and biotech companies stay compliant in a challenging regulatory environment. CSSC’s successful history of providing regulatory compliance solutions to pharmaceutical firms combined with their Siebel Systems validation expertise are reasons why CSSC was selected to conduct these validations.
The process of validating computer systems is a task which requires an in-depth knowledge of industry regulations and requirements. CSSC has extensive experience performing all aspects of regulatory validation for the pharmaceutical, biotech, and medical device industries, and specific expertise in validating Sales Force Automation and Sample Accountability Systems such as Siebel. CSSC has been performing computer systems validation for these industries for more than a decade.
“Our highly qualified team of validation experts has extensive technical and regulatory knowledge,” said Raymond A. Roggero, president and chief operating officer, CSSC. “Their capabilities ensure that our clients’ computer systems are thoroughly assessed and documentation put in place to demonstrate that each system performs exactly according to specifications, in a consistent manner, and in compliance with federal regulations.”
CSSC has extensive experience performing computer systems validation in the areas of Laboratory Information Management, Computerized Maintenance Management, Sales Force Automation & Sample Accountability, Enterprise Resource Planning, Building Management, Clinical Labeling, HPLC, Record Imaging, Pharmacovigilance, Customer Relationship Management and Manufacturing Execution.
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 6 locations throughout the United States, an office in Singapore 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, pharmacists, and project management professionals are respected throughout the industry for their knowledge and experience. For more information, visit www.csscinc.net .
