With the increased security and documentation requirements introduced in ISO 15189:2022, laboratories are facing sharper expectations for end-to-end validation of their genomic workflows, particularly additional cybersecurity requirements that are now aligning more closely with ISO 27001 – Genomical is already supporting customers through this transition.
Earlier this year, Bryony Thompson from the Royal Melbourne Hospital approached us with a detailed set of questions as part of their IVD validation and NATA assessment process. Genomical already supports many of the new requirements out of the box, and our team provided comprehensive responses to help streamline the evidence-gathering progress.
“This support significantly aided in the preparation of the NATA assessment of our validation, with several responses contributing to the IVD assessment documentation”, said Dr Thompson.
The RMH validated their clinical genomic workflow using sequencing data from AGRF Ltd, orchestrated through Genomical and analysed in Franklin by QIAGEN.
A big thanks also goes to the Decode Science team, the Australian distributor of Franklin by Qiagen, in streamlining the process.
Royal Melbourne Hospital achieves NATA accreditation for genomic workflows using Genomical integrated with Franklin by Qiagen!
