RELIEVING THE STRESS OF REGULAR MAINTENANCE, INSPECTATIONS AND DOCUMENTATION
Quality systems for manufacturing and laboratory operations are easily overlooked in small to medium sized companies. Effective programs for calibration, validation and maintenance are not established overnight and require vigilance to ensure consistent compliance. To help you avoid getting side tracked by growth or change, We provide third party audits to identify compliance issues before the FDA or a customer does. Our experts help ensure that you’re meeting the requirements of your quality system or see how far you need to go to meet it.
OUR QUALITY EXPERTS CAN INSPECT COMPLETE FACILITIES OR SPECIFIC AREAS TO PROVIDE AN OBJECTIVE ANALYSIS OF GMP COMPLIANCE.
WE CAN INSPECT:
- Manufacturing and packaging operations
- Medical Device Manufacturing
- Laboratory operations
- Validation programs
- Calibration and maintenance systems
- Product and process specifications
- Batch and test records
- Equipment vendors including Factory and Site Acceptance Tests (FAT and SAT)
FDA VALIDATION SERVICES
There are many interpretations of process validation, but industry experts agree that it should be the final step in the product and/or process development cycle that ensures production is accurate and consistent over time. In fact, a failed process validation is often the result of incomplete or inadequate process development and testing. The engineering and science professionals at CSA understand the confluence of equipment, materials, facilities, computer systems and people that make up a successful process. Through careful design and detailed analysis, we can help your organization validate the processes critical to your operation to ensure each operates within specifications and complies with FDA expectations.
ENTERPRISE SOFTWARE VALIDATION
Our risk management techniques for GMP software validation can identify and analyze critical system requirements relative to regulatory and your business requirements. We help streamline enterprise software validation while reducing the overall cost of compliance. Our experts can support almost any type of configurable or customized software.