POCTIFY LTD
POCTIFY LTD is a POCTIFY: “A UK advisory and solutions firm for the in vitro diagnostics and laboratory sector: market access, regulatory and quality governance, laboratory transformation and digital governance solutions.”.
What does POCTIFY's software do?
“It runs the governance of a point of care testing service: quality control with Westgard rules and operator lockout, competency records per person and device, EQA management, a verification and precision workbench to CLSI protocols, non-conformances and CAPA, internal audits, a risk register, inventory by lot and expiry, and dashboards across every site.”
在公司資料中查看Does the software interpret patient results?
“No. It is workflow, governance and record-keeping software. It does not interpret clinical results and provides no clinical decision support. Clinical interpretation stays with the responsible clinician and analytical performance stays with the device manufacturer.”
在公司資料中查看Is it aligned to ISO 15189:2022?
“Yes. The modules map to the clauses assessors look at: personnel competence (clause 6.2), ensuring the validity of results through internal quality control and EQA (7.3.7), nonconformities and corrective action (8.7), evaluations including internal audit (8.8) and management review (8.9), with Annex A applying them to point of care testing.”
在公司資料中查看