New Zealand Blood and Organ Service is looking to replace statistical process control software it has used for around 24 years after an assessment identified data integrity risks and limitations with the existing system.
NZBOS has issued a request for information for a modern replacement for the software, which is used across its three manufacturing sites to monitor the quality of blood products and support continuous improvement.
The current commercial off-the-shelf system relies on staff manually entering information transcribed from worksheets to generate statistical process control reports.
NZBOS said the existing software was also a 32-bit program, creating challenges for storing data on servers where 64-bit programs are preferred.
It is looking for either a network-based 64-bit or cloud-based replacement with improved access controls, user traceability and audit history, as well as compliance with GAMP 5 and US FDA 21 CFR Part 11 principles.
Integration with laboratory equipment to reduce manual data entry is “highly desirable”, along with live reporting or dashboards to reduce the need for staff to manually generate reports.
The new system will also be expected to support NZBOS’s obligations under the Public Records Act, New Zealand Information Security Manual and Health Information Security Framework.
The RFI is intended to identify available products and suppliers ahead of a potential procurement process, with NZBOS noting it is not yet seeking formal proposals.
Responses close on 18 September.
Add Comment