12.3 Section relabelled Document control, with To enhance the layout of this section subsections on each element of control 12.3.2 NJRO website new section The NJRO website, VRE and HTA Master – File are all new since the last version, and 12.3.3. VRE new section added – must be included. 12.3.4 HTA Master File new section – QPulse has also been removed, and all added reference to QPulse must be removed. 12.4 Risk assessments now included in the Risk assessments fit alongside SOPs and documents supporting the QMS section other documents supporting the QMS as opposed to a stand-alone section 12.9 Training in Quality Documents added To be clear that training may be online, or via reading (absent in previous version) Appendix C Appendix C from previous document These documents are now held (Role Descriptions) removed separately in the HTA Master File and removed from this section for future proofing, should any changes occur.
12.3 Section relabelled Document control, with subsections on each element of control 12.3.2 NJRO website – new section 12.3.3. VRE – new section added 12.3.4 HTA Master File – new section added To enhance the layout of this section The NJRO website, VRE and HTA Master File are all new since the last version, and must be included. QPulse has also been removed, and all reference to QPulse must be removed. 12.4 Risk assessments now included in the documents supporting the QMS section Risk assessments fit alongside SOPs and other documents supporting the QMS as opposed to a stand-alone section 12.9 Training in Quality Documents added To be clear that training may be online, or via reading (absent in previous version) Appendix C Appendix C from previous document (Role Descriptions) removed These documents are now held separately in the HTA Master File and removed from this section for future proofing, should any changes occur.
Quality-Manual_Human-Tissue-Act_Research-HTA-QUAL-E03-Final.docx