[{"data":1,"prerenderedAt":137},["ShallowReactive",2],{"\u002Fblog\u002Fvalidating-a-sharepoint-quality-register":3},{"id":4,"title":5,"author":6,"body":7,"category":119,"date":120,"description":121,"draft":122,"excerpt":123,"extension":124,"heroImage":123,"heroImageAlt":123,"meta":125,"navigation":126,"path":127,"seo":128,"slug":123,"stem":129,"tags":130,"__hash__":136},"blog\u002Fblog\u002Fvalidating-a-sharepoint-quality-register.md","Validating a SharePoint Quality Register: A Worked Example","QikSolve",{"type":8,"value":9,"toc":109},"minimark",[10,20,25,28,32,39,45,51,57,63,69,73,76,80,83,87,90,94],[11,12,13,14,19],"p",{},"This is a companion piece to\n",[15,16,18],"a",{"href":17},"\u002Fblog\u002Fbeyond-excel-gxp-quality-registers-sharepoint-lists","Beyond Excel: A Practical GxP Approach to Quality Registers Using SharePoint Lists",",\nworking through what validating a SharePoint deviation register actually looks like once the\nrecord-versus-register boundary is settled. This is a proposed risk-based approach — the final\nvalidation strategy should be appropriate to the organisation's own procedures, regulatory context,\nand intended use.",[21,22,24],"h2",{"id":23},"what-is-being-validated","What is being validated",[11,26,27],{},"A SharePoint List configured as a deviation register, where the paper system remains the\nauthoritative GMP record. The paper record stays responsible for the deviation and investigation\nnarrative, root-cause analysis, impact and risk assessment, investigation approval, and signatures\nand supporting evidence. The SharePoint List supports identification and status tracking, ownership\nand due-date monitoring, risk categorisation, root-cause trending, and resource prioritisation.",[21,29,31],{"id":30},"six-core-deliverables","Six core deliverables",[11,33,34,38],{},[35,36,37],"strong",{},"1. User requirements specification."," Define intended use, required functions, users, data, and\nboundaries — describing what the organisation needs, not every capability SharePoint offers.\nRequirements should concentrate on intended use, critical data, access, traceability to the paper\nrecord, and reporting reliability, not on low-value platform features included merely to pad the\ndocument.",[11,40,41,44],{},[35,42,43],{},"2. Functional risk assessment."," Identify credible failure scenarios and whether existing or\nproposed controls reduce risk to an acceptable level: incorrect classification affecting trend\nreports; a missing record reducing visibility of a quality event; incorrect status showing a\ndeviation as closed while the paper process remains open; unauthorised modification of\nclassification or status; lost traceability between the electronic entry and its paper file; and\nincorrect report output from flawed filters or dashboard logic. The paper source reduces some risks\nbut does not eliminate risks relating to trending, oversight, timeliness, or resource allocation.",[11,46,47,50],{},[35,48,49],{},"3. Configuration specification."," Document the controlled configuration implementing the approved\nrequirements and risk controls — field types, required status, and controlled choice values for\nstatus, risk category, and deviation type — with screenshots supporting, not replacing, a clear,\nreviewable specification. Any Power Automate or Power BI connections should be documented here too.",[11,52,53,56],{},[35,54,55],{},"4. Validation plan."," Define how assurance will be established and how the package scales to the\nsolution's risk, complexity, and novelty. In scope: the register configuration, critical data\nfields and classifications, permissions and version history, reporting outputs used for quality\ndecisions, and register-to-paper traceability. Excluded or leveraged: Microsoft's own\nsoftware-development processes, physical data-centre qualification, and generic testing of standard\nSharePoint functions unrelated to intended use. \"Do not re-test Microsoft\" does not mean Microsoft\nis automatically compliant — the organisation remains responsible for its own configuration, data,\naccess model, and reliance decisions.",[11,58,59,62],{},[35,60,61],{},"5. Verification protocol and evidence."," Test that a deviation can be created with all mandatory\ninformation, that saving without a required field is prevented, that only approved risk and\nroot-cause values can be selected, that status history is retained after an update, that access\ncontrol correctly distinguishes editors from read-only users, that an electronic entry can be traced\nto its paper deviation, and that a report or dashboard sample matches the underlying list data.\nAttention should concentrate on critical classifications, access controls, traceability, and\ndecision-supporting reports — not on exhaustively exercising every SharePoint feature.",[11,64,65,68],{},[35,66,67],{},"6. Validation summary report."," Summarise completed evidence and the documented basis for release\n— intended use confirmed, requirements verified, risk controls tested, configuration baseline\napproved, and any residual risk accepted by authorised stakeholders — referencing detailed evidence\nrather than repeating every requirement or test step in full. Bulk does not equate to rigour.",[21,70,72],{"id":71},"why-the-first-register-costs-more-than-the-next-one","Why the first register costs more than the next one",[11,74,75],{},"The first implementation establishes reusable assets: validation templates, list-design standards,\npermission groups, a risk-assessment model, a standard test library, and operational procedures. A\nsubsequent register — a CAPA register, for example — reuses that framework but still needs its own\nprocess-specific assessment: the CAPA-specific intended use, source and ownership, effectiveness-check\nrequirements, and process-specific risk and verification. Reuse is justified where the platform,\ngovernance, controls, and verification methods remain equivalent; a new assessment is required\nwherever the process, data, reports, or quality decisions genuinely differ.",[21,77,79],{"id":78},"when-the-lightweight-approach-is-no-longer-enough","When the lightweight approach is no longer enough",[11,81,82],{},"Risk is determined by intended use and reliance, not by the product name. Reassess the approach when\na solution introduces electronic approval of GMP records or electronic signatures, complete\nelectronic investigations, automated risk classification or product-impact decisions, complex\nworkflow branching or custom code, system-to-system integration, or replacement of the paper source\nrecord. Any of those conditions warrant a more extensive validation strategy than the lightweight\nregister approach described here.",[21,84,86],{"id":85},"the-principle-underneath-it-all","The principle underneath it all",[11,88,89],{},"The goal is not to prove SharePoint works — it is to demonstrate that the organisation's configured\nregister, supporting processes, and controls provide reliable information for their defined GxP use.\nScale the documentation to the risk, complexity, and novelty of the intended use, and the validation\npackage earns its credibility on decision quality, not on volume.",[21,91,93],{"id":92},"related-reading","Related reading",[95,96,97,103],"ul",{},[98,99,100],"li",{},[15,101,102],{"href":17},"Beyond Excel: A Practical GxP Approach to Quality Registers",[98,104,105],{},[15,106,108],{"href":107},"\u002Fproduct\u002Fsharepoint-governance","SharePoint governance pathway",{"title":110,"searchDepth":111,"depth":111,"links":112},"",2,[113,114,115,116,117,118],{"id":23,"depth":111,"text":24},{"id":30,"depth":111,"text":31},{"id":71,"depth":111,"text":72},{"id":78,"depth":111,"text":79},{"id":85,"depth":111,"text":86},{"id":92,"depth":111,"text":93},"Compliance","2026-09-10","A scalable, risk-based approach to validating a SharePoint quality register while the paper record remains the authoritative GMP source of truth.",false,null,"md",{},true,"\u002Fblog\u002Fvalidating-a-sharepoint-quality-register",{"title":5,"description":121},"blog\u002Fvalidating-a-sharepoint-quality-register",[131,132,133,134,135],"sharepoint","quality-register","validation","gxp","data-integrity","4kDZzfXyZvuFWEwa_bByWqMCGdJFN_uUcc-XzTtx40M",1789037363524]