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1. Do you have a full User Requirement Specification (URS) within your LIMS service?
2. Do you have a full (requirements) traceability matrix (RTM) to drive validation for LIMS?
3. Do you have full validation evidence ready for review and fully referenced on your local QMS for LIMS?
4. Which LIMS is in use?
5. When was it last upgraded?
6. When was the URS last reviewed?
7. When did the MHRA last inspect the lab?
8. How much notice did MHRA provide before this inspection?
9. Would you benefit from a review of evidence to assess the transfusion labs “readiness for inspection”?

Download response LIMS (Laboratory Information Management System). 100419