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EQMS, an Enterprise quality management software is emerging in the large enterprise system category. It helps to manage various business processes in the purview of quality and compliance across the organization’s varied business domains. An electronic quality management system with a holistic quality management approach across the verticals makes it an enterprise quality management system.
Now you know what an EQMS is. Further, you might be curious to explore what it offers to ensure that your organization regularly meets the quality and compliance regulations throughout your production and supply chain methods. Meanwhile a company implements an EQMS by keeping in mind the business and quality needs of various processes:
Change is inevitable. Hence have a robust change management process across the organization for process performance, product quality and customer safety.
Sarjen’s QEdge EQMS Change control is a process to manage different change requests in a controlled and coordinated manner which provides checks and balances in the quality system by tracking, reviewing and approving the changes.
Any non-compliance with an established GMP standard, specifications, or SOPs needs to be identified, recorded, and evaluated. Any critical deviation that affects the product quality should be investigated and resolved.
QEdge EQMS deviation management delivers critical quality data promptly and enables quick responses to potential failures in GMP compliance and global regulatory guidelines.
A configurable workflow ensures the creation and effective management of investigation design in place for the identification of root causes with defined responsibilities at each stage for speedy and effective conclusion in a time-bound manner.
QEdge provides complete and transparent investigation management with full traceability on the source and implementation effectiveness.
CAPA (corrective actions and preventive actions) is a strategic approach to mitigate the non compliance and prevent the occurrence of the same situation again.
QEdge EQMS CAPA focuses on timely implementation of the CAPA with proper tracking of the activities. Further, it also assists to check the effectiveness check of the actions taken.
Market complaints are related to defective or ineffective medicines. The immediate attention paid to these complaints must be complete, with evaluation and action to prevent a recurrence.
QEdge EQMS Market Complaint module successfully handles market complaints and ADE/ADRs with provision to investigate the root cause.
Out-of-specifications (OOS) are results of in-process or finished product testing, which fall out of specified limits in Specifications of the product. Particularly, the trend is the comparison of historical data versus time and which defines a trend line for every parameter. Out of trend (OOT) is the result of parameters which falls out of the trend limit.
QEdge EQMS provides both OOS and OOT to handle the different scenarios. Fishbone analysis allows users to identify contributing factors rather than apparent indications, and to rectify the same.
The purpose of a GMP audit is to verify compliance with the principles of Good Manufacturing Practices and to recommend any necessary corrective actions.
QEdge audit management software helps industries to manage a wide range of audit-related activities from planning to reporting results.
Standard operating procedures are instructions that define steps of your business and procedures to perform a particular activity.
Therefore QEdge SOP management software offers a system to track SOPs and manage the SOP life cycle that includes creation, review, approval and release along with distribution with unique distribution code and achieving
The system automatically identifies end customers each time SOPs or work instructions are revised by the system. It sends a notification of the same to their training managers. The case of periodic trainings generates auto alerts for GxP training for the Pharmaceuticals and healthcare segments.
QEdge Training records management Software can include important information on Induction, resume and Job Description to make a complete dossier for each employee. The training certificates are electronically captured and the dossiers are updated once training is done.
Quality risk management is a process of decreasing risks to the quality of the product from start to end to leverage the benefits and have the right balance of risk.
QEdge risk assessment modules consists of occurrence management, potential call detectability, RPN priority, risk mitigation and tracking to ensure that the risk is managed well.
Experience a Digital Transformation journey with a trusted automation and digitization partner. To start, email us at sarjen@sarjen.com or visit qedge.sarjen.com
Sarjen System is serving the Pharma & Life Science industry for the last 25 years. With an experience in the industry & knowledge, we keep updating our products regularly so that they are regulatory compliant at any given point. All our products are greenfield products and technologically updated as per requirements. Explore QEdge – an enterprise quality management software to edge the hassles and be ready for audits anytime.
