Remediation
Problems do arise. Pearl Pathways offers an experienced, responsive team of consultants to assist with all aspects of remediation. Whether you require documentation updates to reflect an as-built state or a complete process overhaul, our advisors will assess, develop a plan, work with appropriate regualtory bodies when necessary, and help you implement corrective and preventive actions (CAPA).
Our remediation services include:
- Root cause analysis of audit or inspection reports for necessary corrective actions
- Training and effectiveness checks
- Process improvement
- System/data analysis and augmentation
- Organizational effectiveness
- Validation services
- Program management
- Management of CAPA process
- Gap analysis of existing quality systems and procedures against regulatory requirements and appropriate standards
- Warning Letter & FDA Form 483 analysis, response, and remediation
- Clinical site rescue and recovery
- Creation of tailored training for employees to address gaps
- Follow up audits