Xybion Corporation 105 College Rd East, Princeton, NJ 08540 Direct: (609) 512-5790 www.xybion.com sales@xybion.com Toll Free: (844) 291-4430 FDA Guidance: Electronic Source Data in Clinical Trial Investigations Basic Criteria and Challenges A Compliance White Paper by Xybion Corporation Regulatory Compliance risk is the number ONE rated risk by the global firms across several sectors. Organizations in the life science space believe that new legislations and regulatory tightening are the key challenges for the industry. Companies that are operating in highly regulated industries, particularly on a global level, face a myriad of challenges in keeping pace with fluid regulatory changes. A well planned technology plan that encompasses automation and BPM can help

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