GxP Solution

“GxP Solutions for All” has been successfully providing customized services and solutions for computer system compliance to a wide variety of FDA/GxP regulated industry in India and abroad. The services and solutions provided by Shardha InfoTech “GxP Solutions for All” optimize compliance and regulatory requirements. This helps the clients to focus on their core business and staying ahead of their competition. The precise implementation of Computer System Validation strategy offered by Shardha InfoTech “GxP Solutions for All” ensures that the computer systems can be used in the manufacture of medicinal products without any adverse impact on quality, efficacy, or patient safety, including electronic records integrity. Our experience spans a wide range of Pharmaceutical, Veterinary, Medical Devices, Hospital Equipment’s and FMCG Information Management Systems, Manufacturing systems (including PLCs and SCADAs), Laboratory Systems (including HPLCs, GCs and FTIRs), Quality Systems (e.g. LIMS), and business/enterprise systems (including ERP Systems such as SAP). In addition to expertise in software validation/QA, our team has the knowledge of FDA regulations and the experience in applying best practices to help pharmaceutical companies meet and maintain their quality and compliance goals methodically and cost-effectively throughout the life cycle of Computer Systems.