Biacore 4000 software facilitates compliance with worldwide regulatory expectations by ensuring the highest level of GxP support and 21 CFR Part 11 compliance. The software is developed in accordance with an accepted development model to ensure adequate validation and includes 21 CFR Part 11 functionality such as:
• User authorization levels: administrator and user levels set access rights to software functions • Published procedures for operational control: enables run and evaluation settings to be locked together in routine assays • Audit trails: tracks record modifications and maintains complete version histories for published procedures • Electronic signatures: for published procedures • Data integrity: access control and enforced version handling
Validation support documentation such as System Assessment Report, Software Conformance and Hardware Conformance Certificates is provided.
GE Healthcare Validation GxP Services provide a comprehensive suite of validation services to support equipment through its entire lifecycle, including retirement and decommissioning. Services include GxP impact assessments, installation and operational qualifications, change controls, and requalifications.
System qualification is performed by certified, GxP trained service engineers and uses a risk-based approach in alignment with recent guidelines such as GAMP (Good Automated Manufacturing Practice) and ASTM (American Society for Testing and Materials).
Comprehensive support throughout equipment lifecycle