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Mitigating Compliance Risks with Secure Document Sharing

Need for Secure Document Sharing 

In the pharmaceutical industry, sharing product-specific documents with contract givers, third-party vendors, or customers is a critical yet challenging task. Traditional document-sharing methods, such as emails or shared drives, lack security, transparency, and compliance with global regulatory standards.  

The need for a solution arises to:  
 Enable secure sharing of documents with external stakeholders.  

 Restrict access to only authorized product-specific documents.  

 Provide an audit trail of document access and activities.  

 Facilitate seamless collaboration without risking data confidentiality.  

How it Benefits  

Secure-Document-Handling

Improved Collaboration

External stakeholders receive real-time access to updated documents, reducing communication gaps. 

Training Extension Forms

User-Friendly Interface

Simplified access with a secure link and intuitive navigation ensures ease of use for non-technical stakeholders. 

Regulatory Compliance

Built-in audit logs meet data access requirements as per USFDA, EU GMP, and other global standards.

Secure Document Sharing

Vendors and customers access only their product-specific documents, ensuring data confidentiality and compliance with regulatory requirements. 

Centralized Document Access

A single portal eliminates the inefficiencies of scattered document-sharing practices. 

Workflow

Unique Link Generation

System generates a secure link for each document being shared with vendor/customer allowing access for document review and approval.  

Secure Login

External stakeholders log in using unique credentials tied to their profiles.  

Role-Based Access Control

Vendors/customers view and interact only with documents relevant to their product or project.  

Seamless Document Interaction

Empower users with the ability to effortlessly view, download, or upload critical documents, ensuring easy access and streamlined workflows at every step.

Audit Trail

Every activity i.e., document access, edits, or downloads is tracked and logged for compliance reporting.  

Secure Document Sharing  with QEdge

QEdge offers a state-of-the-art solution tailored for secure Document Management:  

 Vendor/Customer Access: A secure, access portal designed for external stakeholders.  

 Granular Permissions: Role-based access ensures vendors/customers see only the documents they are authorized to view.  

 Real-Time Document Updates: Stakeholders have access to the latest versions of critical documents, ensuring up-to-date collaboration.  

 Regulatory Compliance: Automatic audit trails and controlled document sharing align with global regulatory standards.  

 Seamless Integration: Integrates seamlessly with existing document workflows for efficient management.  

 Scalability: Accommodates multiple vendors/customers without compromising performance or security.  

Results of Implementation

After implementing the vendor/customer review feature within their QEdge Doc Control and Doc Issuance, a multinational pharmaceutical company achieved

0 %

Faster Document Sharing

Real-time access reduced delays in communication. 

0 %

Enhanced Process Transparency

Both internal teams and external stakeholders had full visibility into document statuses reducing miscommunication and follow-ups. 

0 %

Reduction in Manual Errors

Automated document access reduced errors caused by incorrect sharing, outdated document versions, or untracked changes, minimizing rework. 

0 %

Reduction in Audit Preparation Time

Automated audit trails simplified regulatory reporting.

This feature transformed document management by offering secure, efficient, and compliant access for external stakeholders, positioning the organization for greater operational excellence and regulatory success. 

QEdge Quality Management Software Suite

  • Quality Processes - QMS
  • Document Management - DMS
  • Training Management - TMS/ LMS
  • Product Review - APQR/ PQR
  • Vendor Qualification
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