SOP lifecycle tracking along with role 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.
QEdge makes it easy to automate your SOP process and workflow with beeter time management and resource allocations. QEdge SOP management software offers a system to manage and track SOPs and manage SOP life cycle that includes creation, review , approval and release along with distribution and achieving.
With every process flow, the associated access rights ensure the users to works on tasks defines for them for effective process control.
SOP Control 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. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during regulatory inspections or ISO audits.
Lack of Oversight
It’s difficult to generate accurate and timely reports and trends using disparate tools (electronic spread sheets, flowcharting software, paper documents in binders). 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 (engineering drawings, etc.) manually. Tracking down any document activity is difficult. Making a change in an SOP management system or other document requires manual submission of a change request or discussion of the change in face-to-face meetings.
Disconnected Document Control Processes
Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. Ineffective communication can lead to delays and poor results.
Electronic SOP Management System
Efficient Document Control System
QEdge Document Control automates routing and delivery of SOPs, policies, and other 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 so documents are accessible to all authorized users from 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 quality processes 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 users are able to access the right document any time.
Integrates Training with Document Control Processes
QEdge SOP management is an integrated solution that connects all quality sub-systems like CAPA, change control, audit, customer complaint, and training. 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.