YASH Technologies™, a leading technology services and outsourcing partner for global companies, announces the addition of Computer System Validation (CSV) services to its portfolio. This CSV service will help organizations in the life sciences industry (pharmaceuticals, biotechnology and medical device companies), including healthcare, adhere to FDA regulation mandating validation of computer system maintaining GxP• sensitive process and data with GxP controls and procedures in place to consistently produce products that meet its predetermined specification and SISQPE*• attributes.
The comprehensive set of services offered by YASH Technologies is designed to help organizations manage every step of their compliance journey. To optimize costs, YASH offers flexible onsite, offsite, and offshore delivery options. Key CSV services include:
• End-to-end Validation Services;
• GxP Risk Assessment and Control Mitigation;
• CSV Audits;
• 21 CFR Part 11 Analysis;
• Validation Testing Services.
YASH has already worked with over 30 customers in the life sciences industry in various engagement models and has made investments to develop a dedicated Center of Excellence (CoE) to further develop tools and accelerators to optimize costs for customers.
"Companies in the life sciences industry are under constant scrutiny and face heavy penalty due to non-compliance, including plant shutdown and consent decree," comments Murali Iyer, Life Science Line of Business head for YASH Technologies. "We are pleased we can bring our expertise to help our customers manage adherence to these regulations and help them derive a competitive advantage in producing the highest quality products."
• GxP Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Good Distribution Practice, Good Storage Practice, Good Documentation Practice.
*• SISQPE S-Safety; I-Identity; S-Strength, Q-Quality, P-Purity, E-Efficacy.
About YASH Technologies
YASH Technologies (yash.com) focuses on customer success. As a leading technology services and outsourcing partner for medium and large global customers, we leverage technology and our flexible delivery models to drive performance and business value throughout a customer's enterprise. YASH's comprehensive service approach incorporates a holistic view of our customers that extends beyond delivery. This approach integrates enterprise solutions and services, proprietary best practice offerings, strategic application and maintenance outsourcing, as well as consulting and integration services. YASH is a SEI CMMI (Level 3) and an ISO 9001:2008 certified company with U.S. and India headquarters and regional sales and development offices spread across five continents.