At QV-Compliance we perform Software Validation according to FDA 21CFRPart 11, EU Annex 11 and GAMP5, using V-model.
We can work with templates within your Quality Management System – or we can develop a customer specific solution.
Consultants in QV-Compliance A/S are familiar with best industry practices and are up to date with current regulation.
- Validation Plan and Report (VP/VR)
We can help with planning or perform of validation activities, where we ca identify scope and map the resources.
- Risk Assessment
We can help you with or perform Initial Risk Assessment, System Impact Assessment and Business Impact Assessment.
We can help you with your IT Security Risk Management to secure your Data Integrity. This is done by Identifying
Electronic Records and Signatures, implement Access control, plan and perform Back-up and Restore, plan and perform
Disaster Recovery and plan and execute reliable Data Migration.
- User Requirement Specification (URS)
We can help you prepare a Software specific URS, in addition to your equipment URS (link til anden URS).
The Software URS will typically include requirement for Interfaces to other systems or databases, configuration of User
Interfaces, controls and alarms, back-up and restore, data storage and regulatory requirements.
- Functional Requirement Specification (FRS)
We can help you with identifying Functional Requirements and prepare FRS for a costumer or request a FRS from a vendor.
- Design Specification (DS)
We can help you with prepare DS for a costumer or request a DS from a vendor
- Prepare/review Protocol, Test Case/Script and Report
We can help you with IQ, OQ and PQ Protocols, including Test Case/Script and handling of non-conformities during validation
and Validation report.
- Configuration Item List (CIL)
We can help you gathering information for CIL and prepare CIL.
- Compliance Review
We can help you or perform compliance review of both new and implemented systems according to FDA 21 CFR Part 11
and Annex 11.
Compliance review typically includes identifying and solving IT GAPS:
- IT GAP identification
- IT security
- Data Management
- User Management
- Configuration Management
- Software Administration
We can help you to administrate your software, performing or assist you with:
- System Administrator for GAMP Software
- Category 3, 4 and 5 systems
- User Administration
- Configuring User Interface
- Perform User Review
- Windows Configuration
- User Group and User configuration.
- Prepare Operation and Maintenance SOP´s
- Preparation of Documents
- Review of documents
- Audit Trail
- Audit Trail capture
- Audit Trail review
- Configuration Item List
- Configuration Review
We offer an IT-Validation course. The Course Participants will be equipped with skills and knowledge to perform a full
IT Validation of a Computerized Systems.
The Learning objectives are:
- Introduction to GAMP5, FDA 21CFRPart 11, EU Annex 11
- Performance of Science Based Risk Assessment
- Preparing Validation Documentation
- Monitoring and Periodic Review
- Back-up and Restore
- Data migration
- Disaster Recovery