How a Middle East Pharma Giant Mitigated Security Risks with QEdge's Compliant Document Sharing

About Client

The client is a pharmaceutical company fully integrated, global healthcare provider with strengths across the pharmaceutical value chain. Their facility includes separate units for antibiotics, hormones, and non-antibiotic products. The company has registered 550 products worldwide and collaborates with strategic partners to file ANDAs in the US and new product dossiers in GCC, Europe, and ROW markets by collaborating with various Contract givers for product-specific projects, requiring constant document exchange and regulatory compliance, hence wanting a compliant document management

How a Middle East Pharma Giant Mitigated Compliance Risks with QEdge's Secure Document Sharing

The Hassle

The client faced significant challenges in compliant document management with their external stakeholders, including: 

data security

Lack of Security

Traditional sharing methods such as email and shared drives exposed sensitive product-specific documents to unauthorized access. 

Data Overload

Contract givers often received irrelevant documents, leading to confusion and inefficiency.

Compliance Issues

Compliance Issues

Manual tracking of document access and approvals made it difficult to meet regulatory requirements like USFDA 21 CFR Part 11. 

Inefficiency

Document exchange delays led to slower decision-making and project execution.

Inefficient Tracking

Audit Risks

Limited visibility into external document interactions increased the risk of non-compliance during regulatory inspections. 

These issues hindered the client’s ability to maintain efficient operations and seamless collaboration with external stakeholders. 

Edging out with QEdge (EQMS Solution)

To address these challenges, the client implemented Sarjen Systems’ QEdge compliant document management: DocControl & Doc Issuance system, leveraging its Contract givers Review feature. The solution offered- 

Role-Based Access: Contract givers could access only their product-specific documents, ensuring data confidentiality. 

Secure Portal Access: External stakeholders accessed documents through a single, secure link with multi-factor authentication. 

Real-Time Document Updates: Stakeholders had instant access to the latest versions, eliminating version conflicts. 

Audit Trails: Every document activity was tracked for compliance with regulatory standards. 

Centralized System: All document-sharing activities were managed through one platform, streamlining workflows. 

Tackling the Challenge

Our compliant document management addressed the client’s key challenges effectively

Implemented robust role-based access control and multi-factor authentication to eliminate unauthorized access

Contract givers only accessed relevant documents through personalized dashboards, reducing data clutter.

Automated audit trails and version histories ensured compliance with global regulatory standards like 21 CFR Part 11 and EU Annex 11. 

Reduced document-sharing delays, enabling quicker decision-making. 

The centralized system provided instant proof of document access and approvals during audits, reducing audit preparation time. 

Explore our Enterprise Quality Management Solution and Book a Demo for free today!
Book a Demo

Digital Transformation Business Impact

The implementation of QEdge DocControl & Doc Issuance System transformed the client’s document management practices, delivering tangible business benefits: 

Enhanced Stakeholder Collaboration

Strengthened relationships with Contract givers through secure, transparent document-sharing processes. 

Time Efficiency

Reduced document-sharing turnaround times by 60%, allowing for faster project execution.  improvement through KAIZEN.

Higher Stakeholder Satisfaction

Contract givers reported a 30% improvement in satisfaction, appreciating the simplicity and security of the portal. pliance objectives.  

Regulatory Readiness

Automated document-tracking and compliance features eliminated the risk of non-compliance, securing the company’s reputation during global audits. 

The implementation of QEdge DocControl & Doc Issuance System transformed the client’s document management practices, delivering tangible business benefits: 

About QEdge

With QEdge, bring all the quality processes such as Change Control, Deviation, Investigation, CAPA, Market Complaints, OOS, OOT, Risk Assessment and other quality related activities like SOP management, Training management, Audit management, Vendor qualification and PQR/APQR on a single platform.

 

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 Systems has been serving the Pharma & Life Science industry for the last 25 years. We keep updating our products on a regular basis to serve our customers with products that are compliant. Our products are greenfield products and technologically updated as per requirements.