Welcome To Spark GxP Systems LLP!!
More About usAn ISO 9001:2015 Company
Spark GxP Systems LLP Welcome you to our webpage and invite you to discover our services.
SPARK provides a broad range of Computer System compliance and Validation services in support of clients’ manufacturing, laboratory, and enterprise systems. We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical risk-based approach to computer system validation. And, by verifying the controlled development and implementation of computer systems, we can help clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and protect patient safety.
We have the experience, expertise, and commitment to meet all of your validation and compliance needs.
Our support begins with a group of qualified and experienced persons. We staff projects based on required expertise and scope, providing the most efficient and cost-effective Validation services.
Our Service
SPARK provides a broad range of Computer System Validation (CSV) services in support of client’s manufacturing, laboratory, and enterprise systems.
ENTERPRISE SYSTEMS VALIDATION
- - Enterprise Resource Planning (ERP) System i.e SAP, MS Dynamics NAV, Oracle, batchmaster, Progen etc.
- - Quality Management System (QMS), Document Management System, Electronic Batch Records System
- - Laboratory Information Management System (LIMS)
- - Track and Trace and Art work Management System
AUTOMATION & CONTROL VALIDATION
- - PLC-HMI-SCADA based Process Control Systems
- - Distributed Control System (DCS)
- - Building Management System (BMS)
- - Manufacturing Execution System
LABORATORY COMPUTERIZED SYSTEMS VALIDATION
- - Computerized Analytical Systems i.e HPLC/UPLC, GC, Stability Chambers etc.
- - Chromatography Data Systems
- - Spreadsheet (Excel Sheet) and other desktop Applications
- - Clinical Research Software, Customized Application Software.
IT INFRASTRUCTURE AND ASSOCIATED SERVICES VALIDATION
- - PC, Servers, Desktop Applications
- - Network
- - Databases
- - Internet/intranet Applications
- - Disaster Recovery Site
CLINICAL SYSTEMS VALIDATION
- - Clinical data processing and management System
- - Clinical trial management Software
