Auditing is a critical component of following FDA GMP (Good Manufacturing Practice). Many companies’ Quality Assurance groups are working hard to keep GMP audit programs organized using various manual processes and spreadsheets. Management is requesting a comprehensive snapshot of key audit program metrics. Auditors are in need of a tool to drive a more efficient auditing process with greater control over and improved visibility into quality and compliance processes. Whether your role is internal or external, auditor or a stakeholder in the process, the TrackWise GMP Auditing Solution can help your organization streamline GMP audits.
The web-based TrackWise GMP Auditing Solution features the Audit Execution Package which now provides an FDA compliant method for auditors to draft audit reports offline while out in the field. The solution also provides organizational management consistent data to evaluate audit program effectiveness. Since the solution includes the standard TrackWise software, customers receive the quality, compliance, and workflow management capabilities inherent to TrackWise. For organizations looking to consolidate their auditing processes, the TrackWise platform also can support all types of audit programs in one enterprise system.
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The need to measure and ensure quality is vital throughout all aspects of the manufacturing process. TrackWise enterprise quality management software provides a flexible and configurable platform for tracking and managing quality and compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon. In addition to managing all aspects of the audit process, the TrackWise GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessments, risk management and the analysis and approvals of changes. TrackWise also tracks and manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.