are assigned to your project from its initiation and full compliance is assured through in-life, in-process, protocol, data, documentation and report audits conducted on every study or project. Our standard operating procedures (SOPs), test methods and training documentation are all issued and maintained under strict document control by our quality assurance group. Our team and processes assure regulatory compliance with FDA, CE guidelines that include but are not limited to GLPs, cGMPs, ISO and ICH Q7 guidelines.
Throughout the progress of your study, all documents/data are archived to assure complete and accurate documentation in addition to the retention to regulatory requirements. All validation/qualification programs are coordinated through validation specialists on our team in conjunction with the operational divisions and the corporate computer validation committee.
While our focus and dedication for our quality assurance staff is internally driven, and the associates are available for consulting audits.