Case Number 6583
Request Date 25/02/2019
Completion Date 23/03/2019

 

Details of the Request

Please could you answer the following questions around your Trust’s LIMS (Laboratory Information Management System)

  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”?"

 

Details of the Response

1. Do you have a full User Requirement Specification (URS) within your LIMS service?

Yes

 

2. Do you have a full (requirements) traceability matrix (RTM) to drive validation for LIMS

Yes

 

3. Do you have full validation evidence ready for review and fully referenced on your local QMS for LIMS?

Yes

 

4. Which LIMS is in use?

Winpath Enterprise

 

5. When was it last upgraded?

December 2018

 

6. When was the URS last reviewed?

As above

 

7. When did the MHRA last inspect the lab?

2016

 

8. How much notice did MHRA provide before this inspection?

The Trust does not have this on record

 

9. Would you benefit from a review of evidence to assess the transfusion labs “readiness for inspection”?

No, this is done as part of our internal audit process to ensure we are 'always ready'