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Regulatory bodies such as the US FDA and European Medicines Agency (EMA) are increasingly requiring more evidence of compliance to regulations such as 21 CFR Part 11 and Annex 11, respectively. In essence, regulated organizations must be able to both verify the identity of system users and limit system access to trained, authorized individuals. Only under these stringent conditions can data and results be used to defend biopharmaceutical submissions. We have introduced a new software system for high resolution mass spectrometry to ensure regulatory compliance in the biopharmaceutical market. The software provides workflows for biopharma characterization of intact proteins, protein digests and released glycans. To support traceability, a new Control Panel manages projects, users, roles, and permissions for MassHunter Acquisition for LC/TOF and Q-TOF, Quantitative Analysis and BioConfirm. In addition, it is possible to set policies for an Application Lock and Timeout so a “bad actor” cannot take advantage of an authorized user’s absence. Automated audit trails clearly document the “who, what, when, where and why?” of work performed. These entries enable staff and regulatory inspectors to reconstruct the complete history of an electronic record. OpenLab Server/ECM XT enables organizations to collect, organize, and store their data which meets today's regulatory requirements. This occurs behind the scenes so that users do not have to do anything special to upload to this centralized single record. All data archived is versioned on the server so that older results can be reconstructed if necessary. Users can access results and reports remotely, allowing instruments and staff to continue working during data reviews and inspections. Finally, reviewers can apply eSignatures to create check-summed documents, guaranteeing data integrity. The entire software system enforces automated technical controls to assist laboratories in meeting compliance regulations.