Information System Qualification
Evidence your Information Systems are suitable for their intended use
Information System (IS) Qualification documents that your IS system is installed correctly and functioning per specification. This activity falls within the scope of Validation. While an IS system may not directly relate to physical processing activities, system’s that store and/or manage product data may have the potential to impact patient safety. These GxP systems must undergo qualification.
Services
- Validation Project Management
- Validation Plan Development and Execution
- Change Control Documentation
- System Assessment (GxP)
- Risk Assessment & Mitigation
- User Requirements (URS) Development
- Design Specification Documentation (compilation of vendor documents)
- Maintenance Plan Implimentation
- Validation Issue Resolution
- Design Review
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requirements Traceability (RTM)
- Validation Report Development
- System SOP Development
- System Training
Information System Examples
Information Systems are considered to be computer systems that manage and store GxP data.
- Historian
- PI
- Maintenance Managment System
- Document Managment System
- Change Control System
- Laboratory Information Managment System (LIMS)
- Electronic Lab Notebooks (ELN)
- Chromatography Data Systems
- ERP System
- Document Managment System
- Data Aggregation & Analytics System
CUSTOMER COMMENTS
Customer comments
“Sequence has been, without a shadow of a doubt, the most customer-centered company with whom I have ever had the pleasure to work.” – Director, LinkedIn
“Compliance and Data is critical to our business. Sequence understands that the right data management solution must fit our business needs as well as our compliance strategy.” – Sr. Manager, LinkedIn
“Sequence took our vision and with the most amazing teamwork strategies I have ever witnessed turned it into a viable reality.” – Sr. Manager, LinkedIn
“Thank you for the amazing efforts of your most innovative and hardworking staff.” – VP, LinkedIn