FDA Compliance Bulletin: FDA 21 CFR Part 11 Electronic Records | AssurX
This FDA compliance bulletin describes the designed, intended compliance of AssurX QMS Software with FDA 21 CFR Part 11 Electronic Records: Electronic Signatures from the software functionality and integration aspect.
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Corrective and Preventive Action (CAPA) Software
Capture incidents from every part of your organization and efficiently manage their resolution – from root cause analysis to action planning, implementation and review. No matter where an issue arises, AssurX’s corrective and preventive action (CAPA) software can isolate it and assist you in sw...
Document Management Software
Manage your entire document lifecycle—from creation and revision to training—in one central repository. Automate the storage and management of documents across the enterprise and throughout document lifespans with AssurX document management software. The software provides collaboration tools...
Training Management Software
Automatically ensure proper training compliance in complex, fluid environments. Training management software from AssurX ensures your personnel are always effectively prepared for the job, all training is properly documented and histories are accessible, auditable and correctly reported,&...
Compliance Management Software
Automate, track, and manage all compliance related activities—from documentation to mitigation and reporting. AssurX compliance management software automates the tracking and control of compliance related activities—from documentation to planning, scheduling, reporting, mitigation ...
Change Control Management Software
Process any type of proposed change and efficiently manage its evaluation, planning, implementation and documentation across every part of your operation. Orchestrate, track and document changes across all areas of your business with AssurX Change Control Management software. Our automated ...
Audit Management Software
Keep auditing controlled and efficient, automatically record all audit information for easy retrieval, and identify and track trends. Automate and streamline your entire audit process from initial planning to tracking trends. AssurX audit management software allows you to plan, sch...
Complaint Management Software
Efficiently process complaints across operations from intake to investigation, reporting assessment, root cause analysis, corrective action and regulatory reporting. Automate and streamline the complaint lifecycle from product event intake through investigation, root cause analysis, corrective...
Supplier Quality Management Software
Monitor and audit your supplier base, track and resolve issues with purchased goods in receiving, production and the field to improve supplied product quality and supplier performance. Extend quality into your supply network with supplier quality management software to improve prod...
Customer Quality Management Software
Efficiently manage the processing of customer reported quality issues from intake through resolution. Customer quality management software from AssurX improves responsiveness and customer satisfaction while ensuring consumer and partner reported quality issues are always properly documented ...
Manufacturing Quality Management Software
Process quality incidents from detection through investigation, disposition, corrective actions and change control. Streamline and automate the tracking, documenting and resolution of manufacturing-related quality incidents, such as non-conformances, deviations, defects, failures and excepti...
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