Quality and Compliance is integrated throughout all the services offered by Colorado Lagniappe, LLC. We can help your business establish and execute your policies and procedures in accordance with relevant regulatory requirements, guidance, and consensus standards to ensure you are in compliance.
- GxP gap assessments, audits, and regulatory inspection readiness
- GxP documentation development and/or review (e.g., procedures, protocols, reports, specifications, batch records, training materials, master plans)
- Quality Management System (QMS) support to include, but not limited to:
- Batch certification
- Data integrity
- Deviation investigation and reporting.
- Change management.
- Corrective Action/Preventive Action (CAPA) strategy and effectiveness
- Quality systems support
- GMP strategy development
- Quality support on optimization, implementation, and training
- Process validation services