- Banking and Financial Services
- Life Sciences
- Logistics and Travel
- Core Services
- Product Engineering
- Continuous Testing
- Enterprise Solutions
- IT Ops
- Legacy Modernization
Ensure Compliance with Syntel’s Risk-Based CSV Approach
Increasing scrutiny by regulatory bodies and emphasis on product safety and effectiveness is putting pressure on life sciences companies to cost effectively reduce compliance and product recall risk. Syntel’s CSV solutions help our clients ensure that their GxP systems operate with peak quality and efficiency to meet quality and regulatory requirements, while minimizing risk and legal costs.
Our experienced consultants have real-world experience in laboratory, pre-clinical, clinical, drug safety and regulatory areas, plus a powerful set of CSV templates, processes and procedures, tools, and reusable assets to reduce your CSV timelines.
We offer an end-to-end suite of Computer System Validation services, from planning to execution and documentation of IQ, OQ, PQ and all other validation deliverables that meet GAMP 5 standards. Our services include:
The client is a global medical device, pharmaceutical and biotech company. They were facing increased litigation due to regulatory submissions that did not adhere with FDA 21CFR11 regulations and guidelines. They clearly needed help ensuring that their applications were compliant in GxP regulated areas, so they turned to Syntel based on our life sciences expertise as well as our robust, risk-based computer system validation (CSV) methodology.download PDF