EMR IT Solutions computer validation engineers will help ensure that your computerized systems are developed and qualified following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance.
We have developed a process and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP and 21 CFR Part 11. This process will assure the quality of computerized systems through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. This process includes the following steps customized to your unique needs:
- Supplier/Vendor Audits
- Client Validation Life Cycle Audit
- 21 CFR Part 11 Audits/ Remediation Plans
- Policies & Procedures Development
- Software Validation
- Validation Plans
- Disaster Recovery Plans
- Operation & Security SOPs
- Change Management and Control
- System User Requirements and Design Documents
- Protocols, Test Plans, Test Scripts
- 21 CFR Part 11 Training
Our Services Include :
Validation Services
Below lists a partial portfolio of services that Validation Plus, Inc. provides. Please click on each name below for a more detailed overview. If you don't see your specific need listed, please contact us for additional information or request a free consultation on your specific requirements.
- Master Planning
- Protocol Preparation and Execution
- Report Preparation
- SOP Preparation
- Project Management
- HVAC Systems
- Water Systems
- Other Utility Systems
- Sterilizers
- Fermentation Systems
- Purification Systems
- Filling Systems
- Computer Validation and 21 CFR Part 11
