Controlled Certificate of Analysis Management
SoftGroup® CoA helps pharmaceutical QC laboratories manage Certificates of Analysis through a clear, validated electronic workflow.
From template-based generation to multi-level QA approval, the system ensures centralized control of CoA records, full traceability of laboratory activities, and audit-ready documentation across regulated manufacturing environments.
Centralized CoA Generation and Storage
SoftGroup® CoA automates the creation and printing of Certificates of Analysis using approved templates.
All issued CoAs are stored in one controlled repository, making retrieval, review, and reporting consistent across products, batches, and markets.
Approval Workflow with Defined QA Levels
The system supports structured approval stages (QA Level 1, Level 2, Level 3), ensuring segregation of duties and controlled release of certificates.
Each approval step is recorded, supporting compliant quality operations.
Audit Trail and Inspection-Ready Traceability
Every action from creation, modification, approval, and printing is captured in the audit trail.
This provides complete history and accountability, reducing the effort required during investigations, submissions, and regulatory audits.
Certificates of Analysis, Under Full Control
SoftGroup® CoA provides a validated environment for generating, approving, and issuing Certificates of Analysis electronically. It centralizes batch results, applies role-based QA approval levels, and maintains full traceability to support GMP-compliant laboratory operations.
From Test Results to Approved CoA in a Controlled Workflow
Configure Templates and Nomenclatures
Set up products, destinations, parameters, and CoA templates in a controlled test environment before moving to production.
Register Batches and Capture Results
Enter batch-specific data and store final analytical results centrally, ensuring consistency across products and markets.
Generate Certificates Automatically
Create CoAs electronically using approved templates, with standardized layouts and customer-specific formatting.
Approve, Audit, and Report
Apply multi-level QA/QP approvals with a full audit trail, secure access control, and reporting for inspections and trend analysis.
