Integrated quality management across R&D, scale-up and production
Capot integrates quality assurance, quality control, documentation management, supplier quality, and continuous improvement across R&D, process scale-up, and manufacturing.
Explore our quality system →Quality System Framework
Quality Assurance
Supports consistency and control of project execution and production through quality systems, documentation management, audits, and oversight mechanisms.
Quality Control
Ensures quality of raw materials, intermediates, and finished products through analytical testing and release management.
Documentation & Traceability
Ensures full traceability across R&D and production through controlled documentation and batch record management.
Continuous Improvement
Drives ongoing improvement of the quality system through deviations, changes, investigations, audits, and corrective actions.
Quality Assurance & Control System
Quality Assurance (QA)
- Document Control：Management of quality standards, SOPs, master batch records, and other controlled quality documents.
- Batch Review & Release：Review of batch records and related quality information before product release.
- Change Management：Evaluation and documentation of changes that may affect processes, product quality, or compliance.
- Deviation Management：Standardized review and investigation of deviations, out-of-specification results, and quality events.
- Training Management：Role-specific training to support consistent execution of procedures and quality requirements.
- Internal Audits：Periodic internal audits to drive effective operation and continuous improvement of the quality system.
Quality Control (QC)
- Raw Material Testing：Sampling, testing, and release of raw materials according to applicable quality standards.
- In-Process Control：Supporting production process control through in-process samples and intermediate testing.
- Finished Product Testing：Analytical testing and quality review before finished product release.
- Cleaning & Process Support：Providing analytical support for cleaning validation and process-related quality control as needed.
- Analytical Method Transfer：Supporting analytical method transfer and related qualification or validation per project requirements.
- Stability Support：Providing stability studies and monitoring support based on project or customer requirements.
Quality Management Throughout the Project Lifecycle
Supplier Quality Management
Supplier Qualification
Suppliers are evaluated based on quality, reliability, and project requirements.
Material Management
Raw materials are managed according to established quality requirements and approval procedures.
Supplier Audits
Supplier performance and quality information are reviewed as needed.
Quality Documentation Support
Based on specific product and project requirements, Capot can provide corresponding quality and technical documentation support.
Need Quality Support for Your Project?
Contact us to discuss product quality standards, analytical requirements, and related quality documentation needs.
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