Deviations management is a key role in assuring product Quality, Purity and Strength. Any non-compliance of an established GMP standard or of approved requirements, specifications and standard operating procedures (SOPs) needs to be identified, recorded and evaluated. Any critical or major deviation which affect the product quality, reliability of procedure or records should be investigated and resolved. Organizations can depend on the software for a complete audit trail that supports compliance with part 11 requirements. The system also supports e-signatures, data integrity, and data security for better compliance.
The system supports integration with the Document Management System to help users easily access supporting documents, pre-saved templates and Standard Operating Procedures (SOPs) relevant for deviation management.
QEdge Deviation Management
QEdge EQMS has well-designed deviation management, available for ready to use. In QEdge deviations management software, each deviation is addressed and investigated systematically, identifying the root cause analysis and when and how immediate actions, corrective actions, or preventive actions (CAPA) have been taken to prevent recurrence.
Our EQMS delivers critical quality data in timely manner and enables quick response to potential failures in GMP compliance and global regulatory guidelines.
QEdge delivers comprehensive deviation reports at any time along with trending, irrespective of wherein the organization the deviation has occurred.
Key Benefits of Deviation Management
Regulatory Compliance
It enables live tracking of deviations and supports automation of alerts and notifications
Deviations management with minimal manual entries
Accountability can be maintained with workflows and assignments
The workflows can be configured as per the organization’s requirements and reports can be generated in accordance with the deviation templates of the company to suit your current process
Offers controlled environment with flexibility
Central database provides full control and traceability from regulatory perspective
Deviations Management deals with different types of deviations such as standard (common) deviations and laboratory out-of-spec deviations. The system provides pre-defined reports for initiating any possible deviation investigation. The entire deviation process is supported by the system, from initiation and investigation, to review, approval and closure in compliance with CFR 21 Part 11.
