GXP Consultants offers a full range of Information Technology (IT) Services for design and implementation of hardware and software and validation employing methods and models of GAMP. We can assist you with all aspects of CSV (Computer System Validation) from preparation of procedures and policies through preparation and execution of protocols in order to achieve compliance with the current FDA requirements and policies for Computer Validation and 21 CFR Part 11 Compliance.
GXP Consultants IT Design, Implementation and Validation Group offers:Function:
- IT Network Design, Implementation, Validation and Training
- Applications Development and Project Management
- QA and SOP Development, GAMP Methodology
- Software Development Life Cycle (SDLC)
- EAI Enterprise Application Integration
- ERP, Enterprise Resource Planning
- SAP, Oracle, PeopleSoft
- Risk Management Assessment and Analysis
- GAP Analysis and Master Planning
- Remediation Planning
- User Requirement and Specification Preparation
- Protocol Preparation and Execution
- Reports
Software & Systems:
- Electronic Data Base Management Systems (EDMS)
- Implementing Paperless Documentation System
- Manufacturing Execution
- Material Management
- Document & Material Management
- Inventory Management
- Process Control and Production
- SCADA
- DCS
- PLC
- Packaging and Labeling
- Facilities Systems
- BMS
- HVAC
- WFI
- Laboratory Automation Systems (LIMS)
- Computer Database Systems
GXP Consultants consists of individuals with experience in both regulatory compliance and information technology, with a wide range of computerized systems and applications.
Together we will develop and successfully arrange an assessment tool for GMP determination and 21 CFR Part 11 Compliance. Our process systematically evaluates both early and late model computer systems to determine GMP and Part 11 compliance.
13681 Newport Avenue
Suite 8-620
Tustin, CA 92780
(714) 325-8896
