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Short answer, no! We have had to re-write all of the original validation/verification data as the old format did not comply with our new validation and verification SOP. We used to have all data stored as Excel spreadsheets with technical and clinical sign off, but as we now use 'technical files' in our QMS, we have had to transfer all old data into this new format. Maybe we were just unlucky with our inspector??????????? Good luck! Rachel Rachel Webster Consultant Clinical Scientist - Dept. of Clinical Biochemistry Tel: 0121 371 5997 Internal: 15997 Email: [log in to unmask] Web: http://www.uhb.nhs.uk Room 10 Laboratory Medicine Clinical Biochemistry - University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston Birmingham, B15 2GW [cid:image002.gif@01D1E0DA.1AD16D40] From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of OConnor John (ROYAL DEVON AND EXETER NHS FOUNDATION TRUST) Sent: 18 July 2016 09:45 To: [log in to unmask] Subject: UKAS Dear Collective How have labs found the UKAS inspections in the context of validation/verification of historical methods that may have been in use for many years. Is a reference to the original work acceptable with on-going evidence of good performance using EQA and IQC?. BW John Dr John O'Connor Consultant Clinical Scientist Lead Scientist RDE [exeter-clinical-laboratory-international] Website: www.exeterlaboratory.com<http://www.exeterlaboratory.com> ******************************************************************************************************************** This message may contain confidential information. If you are not the intended recipient please inform the sender that you have received the message in error before deleting it. Please do not disclose, copy or distribute information in this e-mail or take any action in reliance on its contents: to do so is strictly prohibited and may be unlawful. Thank you for your co-operation. NHSmail is the secure email and directory service available for all NHS staff in England and Scotland NHSmail is approved for exchanging patient data and other sensitive information with NHSmail and GSi recipients NHSmail provides an email address for your career in the NHS and can be accessed anywhere ******************************************************************************************************************** ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk Green Laboratories Work http://www.laboratorymedicine.nhs.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/ ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk Green Laboratories Work http://www.laboratorymedicine.nhs.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/