Quality and Compliance is a discipline that employs the use of quality assurance and quality control tools either to establish compliance or to determine the level of compliance with operational processes and procedures. Team Validation LLC provides the following Quality and Compliance services to its clients:

Auditing:
Team Validation LLC provides worldwide audit and consulting services to the pharmaceutical, medical device, and biotechnology industries. Our auditing methodology to evaluate organizational structure, policies, procedures, and practices are consistent with the latest industry standards. Please allow our expert staff to help you find practical solutions for regulatory compliance issues, to develop and maintain quality systems, and to ensure the validity and accuracy of your study data. Our audits will assist you in assessing the adequacy of site, vendor, and sponsor study conduct and compliance with FDA regulations and guidelines, ICH GCPs, local and international regulations, protocol, and SOPs.

CAPA:
Organizations who pursue continual improvement must address the concerns of nonconformances and develop corrective/preventive actions to prevent the repetition of these occurrences in the future. Team Validation LLC can assess your non conformances and recommend an appropriate solution for the management of nonconformances.