Our Quality Management System
Our Quality Management System (QMS) ensures end-to-end control of our design, manufacturing, testing, and documentation processes. Built on internationally recognized standards, our QMS enables us to consistently deliver reagents that meet scientific, regulatory, and customer expectations.
Key Components of Our QMS Include:
Rigorous employee training programs ensuring technical competence and regulatory knowledge.
Supplier qualification and management to guarantee high-integrity raw materials and components.
Calibration, maintenance, and validation of equipment used in production and QC testing.
Documented procedures and controlled records to ensure complete traceability.
In-process controls for purity, activity, stability, and performance verification.
Corrective and Preventive Action (CAPA) programs to drive continuous improvement.
Regular internal audits to ensure ongoing alignment with our quality and regulatory commitments.
Products entering regulated workflows may be supported with additional documentation upon request.
Protein Expression, Purification & Analytical QC
Quality at SignalChem Diagnostics begins with how we design, express, and purify proteins. We utilize bacterial, yeast, insect, plant, and mammalian expression systems to ensure proper folding, post-translational modifications, and biological activity.
Our purification platforms are optimized to preserve structural integrity and functional performance – critical for assays involving CRISPR mechanisms, enzymatic reactions, or immunological detection.
Each lot undergoes a suite of analytical QC tests, which may include:
- Purity analysis
- Activity assays tailored to each protein class
- Stability and shelf-life evaluation
- Functional assay validation relevant to intended use
Regulatory & Compliance Framework
SignalChem Diagnostics is committed to maintaining a QMS aligned with current international standards and regulatory expectations for research-use reagents and diagnostic components.
Our systems and processes support:
- ISO 9001 principles of robust, reliable manufacturing
- ISO 13485–aligned workflows for design, development, and production of diagnostic-related materials
- Compliance with biosecurity and ethical sourcing standards
- Traceability of raw materials, intermediates, and final products
- Risk-based quality controls at critical manufacturing points
Documentation such as certificates of analysis (CoA), safety data sheets (SDS), and regulatory support files are available for all catalog products.
