Computer System Validation is a integral part and perhaps the most critical aspect of regulatory requirement for fundamentally every process in the global health care industry.
At ICS, we provide specialized GxP- compliance IT services to ensure secure, compliance, and efficient operations for industrial manufacturing automation systems and laboratory instruments.
We provide both on-site and laboratory-based calibration, depending on your equipment and urgency.
ICS provides O&M contracts that cover the end-to-end operation and upkeep of utility and automation systems. With a safety-first approach and highly trained manpower, our services ensure smooth, efficient plant functioning.
Computer System Validation is a integral part and perhaps the most critical aspect of regulatory requirement for fundamentally every process in the global health care industry. At ICS, validation services are a major part of the offering basket. We have one of the biggest team strengths of Experienced Engineers. We are providing our best quality services for PLC/Computer System Validation since 2016 in accordance with Guidelines of Good Automated Manufacturing Practices (GAMP 5).
Life Sciences companies manufacture life-saving drugs, where product quality is critical. To ensure consistent quality, manufacturers increasingly use automated, computer-based processes, generating and storing large volumes of electronic data for defined periods. This data is crucial for both manufacturers and regulators. The U.S. FDA governs such electronic records and signatures under 21 CFR Part 11. At ICS, we implement 21 CFR Part 11 compliance as part of validation activities, aligned with the company’s quality management system.
GAMP 5 aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.
GAMP 5 recommends the V-model for Computer System Validation, following a sequential SDLC approach in a V-shape. The left arm represents specification phases—User Requirements Specification (URS), Functional Specification (FS), and Detailed Design. The right arm represents validation phases—Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Both arms converge at the V-point, covering Build and Unit Testing. Category 5 custom applications, components, and electronic signatures are also addressed within this framework.
We offer Validation services as per the regulatory compliances & requirements in Life Sciences industry
At ICS, we provide specialized GxP- compliance IT services to ensure secure, compliance, and efficient operations for industrial manufacturing automation systems and laboratory instruments.
We support Quality Informatics and Manufacturing Informatics, managing software for laboratory equipment, PLCs, and SCADA systems. Acting as Application & System Administrators, we handle user management, backups, restorations, OS hardening, and periodic reviews, ensuring full compliance with 21 CFR Part 11 and other regulatory requirements.
ICS offers customized AMC solutions for a wide range of control and automation systems. Our team of experienced engineers and embedded field technicians ensures proactive and responsive support to meet your plant’s operational needs.
ICS provides O&M contracts that cover the end-to-end operation and upkeep of utility and automation systems. With a safety-first approach and highly trained manpower, our services ensure smooth, efficient plant functioning.
