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Computer System Validation Solutions from Transcat
Computer System Validation (CSV) is a critical process in FDA-regulated industries, involving a structured approach to verify that:
- Computer systems are properly designed
- Software is installed to specification
- Systems are functioning according to established user needs
In sectors such as pharmaceuticals, biopharmaceuticals, medical device manufacturing, and diagnostic equipment production, maintaining the integrity of data, patient safety, and product quality is paramount. As such, validating computer systems that control these essential processes is necessary to ensure compliance and minimize risks to product safety and efficacy.
Regulatory Compliance for Computer Systems and Software
The Transcat team offers comprehensive expertise and a wide range of tailored solutions to ensure that your computer systems and software are fully validated. We help confirm that these systems operate in strict alignment with user requirements and functional specifications, guaranteeing reliable performance and compliance with regulatory standards.
Transcat specializes in all aspects of CSV, including:
- Enterprise Systems
- Infrastructure
- Automated Equipment and Manufacturing Lines
- Spreadsheet Validation
- Data Integrity Assessments
- 21 CFR Part 11 Assessments
- Gap Analysis
- Remediation
- Data Tag Modification Procedures
- Configuration Management Procedures
- Software Administration Procedures
- Periodic Review
CSV solutions from Transcat encompass rigorous testing, documentation, and ongoing monitoring to ensure systems meet the required standards throughout their lifecycle. The validation process covers everything from initial installation and configuration to routine maintenance and periodic revalidation.
By partnering with Transcat, you can be confident that your systems will continually support product quality, data integrity, and regulatory compliance, all while ensuring the safety and effectiveness of your manufacturing processes.
Partnering with Transcat CSV Team unlocks the potential to optimize manufacturing efficiencies in your operations. Contact us today for a tailored solution for your unique needs.