Validation
SCI can provide guidance to clients on validation of manufacturing facilities and equipment, including development of all supporting documentation. Our solutions incorporate a practical approach, are based on "good science", and ensure compliance to FDA and European validation requirements. Our team of experts has several years of experience in different aspects of validation, and focus on small companies and small project needs. Our experts can assist you with the following:
- Development of validation strategies
- Development of facility Validation Master Plan
- Regulatory assessment of validation programs (Gap Analysis)
- Oversight of validation execution for simple or complex pieces of equipment
- Preparation for regulatory inspections
- Review of validation protocols and writing of summary reports
- Remediation of deficiencies
Our team focuses on small validation projects, but as a service to our clients, we can coordinate the contracting of personnel for execution of larger projects. Training is available through our Hot Topics Workshops.
