The data that makes up these submissions must be collected following the already established GLP and 21 CFR-Part 11 regulations. The data submitted in the SENDIG v3.1.1 format must accurately represent the study setup and observations, and laboratories are required to ensure this is the case. The SENDIG v3.1.1 submission requires precise documentation of dates, times and methods followed. For this reason, it is more important than ever that your processes support these regulations and that you have the validation framework in place to prove that your processes are being followed.
Xybion’s CQRM XD is a compliance and quality management solution that works in conjunction with Savante – the company’s state-of-the-art data warehousing and SENDIG v3.1.1 data preparation tool. It is used to organize and manage your SOPs and electronic content including SENDIG v3.1.1 datasets and non-clinical study reports. It has modules to create a master schedule of studies, approval workflows, and to ensure you are following GLP regulations through documentation, training, and internal audits.