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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
The client faced significant challenges in compliant document management with their external stakeholders, including:
Traditional sharing methods such as email and shared drives exposed sensitive product-specific documents to unauthorized access.
Contract givers often received irrelevant documents, leading to confusion and inefficiency.
Manual tracking of document access and approvals made it difficult to meet regulatory requirements like USFDA 21 CFR Part 11.
Document exchange delays led to slower decision-making and project execution.
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.
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.
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.
The implementation of QEdge DocControl & Doc Issuance System transformed the client’s document management practices, delivering tangible business benefits:
Strengthened relationships with Contract givers through secure, transparent document-sharing processes.
Reduced document-sharing turnaround times by 60%, allowing for faster project execution. improvement through KAIZEN.
Contract givers reported a 30% improvement in satisfaction, appreciating the simplicity and security of the portal. pliance objectives.
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:
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.
QEdge Quality Management Software Suite
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Phone : +91-79-66214899
Email: sarjen@sarjen.com