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 Streamlining QC Docs: Smarter Compliance with QEdge

Need for Quality Control (QC) documents

In the pharmaceutical industry, maintaining accurate and up-to-date Quality Control (QC) documents such as Specifications, Standard Test Procedures (STPs), and Analytical Worksheets is critical for ensuring product quality and regulatory compliance. Traditional manual or semi-digital document management methods often lead to inefficiencies, errors, and non-compliance risks due to version control issues, misplaced records, and approval delays. Regulatory agencies like the FDA, EMA, and ICH mandate stringent documentation practices to uphold data integrity and traceability. To address these challenges, a robust, automated, and regulatory-compliant document control solution like QEdge DocControl & Doc Issuance System is essential. QEdge DocControl & Doc Issuance System streamlines document management, ensuring accuracy, compliance, and operational efficiency while reducing approval delays and audit risks. 

How it Benefits  

Version Control & Traceability

 Maintains complete document history with audit trails.

Reduced Paper Dependency

Enhances data integrity and supports sustainability goals.

Regulatory Compliance

 Ensures adherence to 21 CFR Part 11, FDA, EMA, and other regulatory guidelines.

Controlled Issuance

Secure and Controlled issuance of documents, to prevent unauthorized distribution

Standardized Documentation

Automated and direct linkage of Specifications, STPs, and AWS.

Process Diagram

Document Creation

Draft Specifications, STPs, and Analytical Worksheets preparation using predefined templates within QEdge. 

Review & Approval

Systematic review and approval process involving multiple stakeholders, with electronic signatures ensuring authenticity.

Training

 Training execution to ensure that staff members are trained on documents before implementation.

Controlled Issuance

 Issuance of approved documents with tracking for archival/retrieval. 

Revisions & Versioning

 Automated record versioning to ensure previous versions are archived and traceable. 

Quality Control documents with QEdge

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

  • Document Lifecycle Management: Streamlined document lifecycle management from Creation to Review, Approval, Distribution, Retrieval and Revision/Obsoletion.
  • Predefined Templates: Ensures all documents follow a consistent structure, format, and regulatory requirements.
  • Integration with TMS: Ensures training completion before implementing critical documents.
  • Dynamic Search & Retrieval: Dynamic search and retrieval enables instant document access during audits.
  • Seamless Integration: Integrates seamlessly with existing with eQMS, MES, ERP, and other enterprise systems.

Results of Implementation

After implementing the solution with QEdge DocControl & Doc Issuance, a full spectrum of pharmaceutical formulations manufacturing company achieved: 

0 %

 Reduction in retrieval time 

0 %

faster document approvals 

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Improvement in Audit Readiness

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Increase in Operational Efficiency

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.