Information System Compliance
Information systems are increasingly becoming the source of quality decisions, manufacturing management and batch records in the pharmaceutical industry. As more complex Commercial-Off-The-Shelf (COTS) systems become available and the need to develop custom applications increases, the requirement and complexity of validating these systems also increases.
Gill’s Process Control has extensive knowledge and experience in validation of Management Information Systems (MIS). Our staff can provide necessary gap assessments, user requirements, functional specifications, and hardware/software design specifications for all commercial and custom information system applications. Our staff can also generate and execute the required software integration testing, hardware/software acceptance and performance qualification of these systems.
Our staff works to develop relationships with the system integrators or vendors to provide comprehensive and realistic user requirements and system design specifications in a manner that is easily understood and defendable to the regulatory agencies. We then provide test documentation to ensure that your process is acceptable, repeatable and consistently achieves the pre-defined expected results.
So whether you are integrating a large Supervisory Control and Data Acquisition (SCADA) system, a site-wide Distributed Control System (DCS) or purchasing a vendor-supplied specific application, Gill’s Process Control can ensure that these systems are installed, operate and perform in a manner that is consistent with your site requirements and in conformance to the regulating authority.
• Downtime Tracking
• Warehouse and Inventory
• Work Order Systems
• Engineering and Services Applications
• Documentation Systems
• Client and Server Systems