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SOP Management

SOP lifecycle tracking along with role and scope-based provisions

Standard Operating Procedures (SOPs) are essential to all GxP compliant processes. SOPs needs to be well organized, up to date, reviewed and approved in a defined schedule, and modified with documentation.

Various activities involved in SOP management are part of QEdge Document Management System.

QEdge makes it easy to automate your SOP process and workflow with better time management and resource allocations. QEdge SOP management software offers a system to track SOPs and manage SOP life cycle that includes creation, review, approval and release along with distribution with unique distribution code and achieving. With every process flow, the associated access rights ensure the users to works on tasks defines for them for effective process control.

QEdge SOP management software organize and upload any new and revised documents using O365 plug-in functionality make easier task to handling in the system also it can be integrated with QMS and TMS application with relevant change request details and manage training completion certificate.

QEdge doc control makes controlled on print feature access for only assigned authorization for prevent data integrity issue.

Paper based SOP Challenges

Inefficient Paper-based Document Control System

Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid SOP management systems. However, In the long term, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, meetings to discuss changes, and manual search and retrieval of documents during regulatory inspections or audits.


Lack of Oversight

It’s difficult to generate accurate, timely reports and trends using manual system. Without an effective reporting tool, managers are unable to get control of their quality standard operating procedure management system.

Lack of Document Revision Control

In a paper-based system or hybrid system, employees check out documents and other materials annually. Tracking down any document activity is difficult in manual system. Making change in an SOP or other document requires manual submission of a change request or discussion of the change by having meetings.


Disconnected Document Control Processes

Communication breakdown is likely to happen in companies that rely on manual system and processes to manage the quality system. Ineffective communication can lead to delays and poor results as lacking interconnection facility.

Electronic SOP Management System

Efficient Document Control System

QEdge Document Control automates routing and delivery of SOPs, policies, and other Regulatory documentation. It’s uniquely qualified to be the focal point of a standard operating procedure management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits. QEdge Document Control is Web-based application so documents are easily accessible to all authorized users virtually anywhere.

Increased Management Viability

QEdge Document Control provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the process and can be more proactive about improving their quality system.

Automated Document Revision Control

QEdge provides automatic revision control to ensure that only the current version of a document is available. Changes can be initiated and approved electronically. When a user makes a change in field the user must enter a reason for the change. The system tracks these changes and makes them available through reports. QEdge Document Control always ensure that users can access document any time.

Integration with other modules

QEdge SOP management is an integrated solution that can integrate with process control and training module. For example, a customer complaint that warrants a CAPA will be immediately escalated. Any CAPA that results into a change will automatically invoke training once the change is approved.