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Efficient Document Workflow for Pharma Compliance Success

 Need for Document Issuance

Pharmaceutical industries operate in a highly regulated environment where managing critical documentation is essential to ensure product quality and compliance with strict guidelines like FDA’s 21 CFR and EU GMP. Many companies struggle with manual or hybrid systems (such as SharePoint) that are not designed for GMP-regulated environments. QEdge addresses these needs by providing a highly automated, compliant, and user-friendly Document Issuance system that eliminates the inefficiencies of manual documentation, improves data accuracy, and ensures compliance with stringent regulatory requirements (USFDA, EMA, WHO). 

How it Benefits  

Automated Workflows

Automating the approval process through configurable workflows reduces delays and ensures faster document review and approval.

Simplified Collaboration

With centralized document storage and secure access controls, employees across departments can work together seamlessly.

Reduced Errors

Automated version control and user notifications minimize the chances of human error, ensuring only the latest approved version of a document is used.

Centralized Document Storage

Ensure quick access to all critical documents from a single secure location, improving retrieval time, enhancing collaboration, and maintaining regulatory compliance.

Process Diagram 

Document Issuance with QEdge

QEdge solves document control and issuance challenges by automating workflows, ensuring real-time version control, and providing full audit trails for compliance. It integrates document management with quality processes, enabling centralized storage, role-based access, and training assignments, which streamlines operations and ensures regulatory adherence for pharmaceutical companies. 

Results of Implementation

Reduced Product Development Time

Reduction in Approval Time

30% reduction in the time taken for document approvals. 

Paper Based System

Efficiency in Document Retrieval

Document retrieval time is reduced by 40%. 

Cost Reduction

Cost Savings

30% reduction in administrative costs related to paper.

Inefficient Tracking

Error Reduction

50% fewer document-related errors due to automated version control and role-based access restrictions. g procedures by seamlessly updating Active Directory.