[{"data":1,"prerenderedAt":414},["ShallowReactive",2],{"cms-page:change-control":3,"icon:alert-triangle":228,"icon:arrows-exchange":239,"icon:chart-bar":246,"icon:clipboard-check":259,"icon:file-text":269,"icon:flag":285,"icon:forms":292,"icon:gauge":311,"icon:message-report":324,"icon:microscope":334,"icon:notebook":356,"icon:refresh":366,"icon:route":373,"icon:school":383,"icon:signature":390,"icon:truck":394,"icon:user-shield":404},{"slug":4,"seo":5,"sections":8},"\u002Fchange-control",{"title":6,"description":7},"Change Control — QAbility Quality Management","Propose a change, route it through review, and close or cancel it under e-signature, linked to the nonconformance, CAPA or audit finding behind it.",[9,25,137,150,159,182,201,221],{"type":10,"id":11,"eyebrow":12,"title":13,"highlight":14,"blurb":15,"actions":16,"image":23},"hero","top","Change Control","Nothing changes","without a record.","A change request carries the problem that caused it, the reasons for it, the review that approved it, and a signed close or cancel. Its status moves only where the database allows.",[17,20],{"label":18,"href":19},"Book a demo","\u002Fcontact",{"label":21,"href":22},"Follow one change","#thread",{"src":24},"change-control.lineage",{"type":26,"name":27,"id":28,"eyebrow":29,"title":30,"blurb":31,"data":32},"signature","changeThread","thread","One change, end to end","A change carries its cause, its case and its signature.","Follow a single change request from the record that caused it to the signature that ends it.",{"nodes":33},[34,58,89,97,123],{"id":35,"label":36,"title":37,"body":38,"panelLabel":39,"panel":40},"origin","Origin","It starts from the problem that forced it.","Raise the change from a nonconformance or a CAPA and the link is written as the change is created. The change carries its origin for life, and the origin shows what it led to.","Drawn from the CR-4001 breadcrumb",{"kind":35,"trail":41,"sources":48},[42,45],{"kind":43,"id":44},"NC","NC-1057",{"kind":46,"id":47},"CR","CR-4001",[49,52,55],{"name":50,"how":51},"Nonconformance","Raise the change from the NC. The link is stored as the change is created.",{"name":53,"how":54},"CAPA","Raise the change from the CAPA. The link is stored as the change is created.",{"name":56,"how":57},"Audit finding","Point the finding at the change it produced. The change shows the audit it came from.",{"id":59,"label":60,"title":61,"body":62,"panelLabel":63,"panel":64},"request","The request","It says what is changing, and why.","The reason and the business justification sit on their own tab, beside the change details a board decides on. In the app the form is editable only while it’s a draft, and the CR number is issued on first submit, so a draft that goes nowhere leaves no gap in the register.","The fields on a change request",{"kind":65,"groups":66},"fields",[67,76],{"title":68,"fields":69},"Reason & justification",[70,73],{"label":71,"value":72},"Reason for change","Why the change is needed",{"label":74,"value":75},"Business justification","Why it is worth making",{"title":77,"fields":78},"Change details",[79,82,84,86],{"label":80,"value":81},"Classification","Minor, major or critical",{"label":83,"value":83},"Planned or emergency",{"label":85,"value":85},"Temporary or permanent",{"label":87,"value":88},"Regulatory impact · Customer notification","Yes or no, each",{"id":90,"label":91,"title":92,"body":93,"enforcedBy":94,"media":95,"caption":96},"review","Review route","Your route reviews it.","The change runs on the same approval engine as documents, CAPAs and NCs: reviewers by role or by name, any-or-all approval, an SLA per step, and an e-signature wherever a step demands one. Every new company starts with impact assessment, an approval that each approver signs, then implementation as sub-tasks.","configure","change-control.review","CR-4001 · Approval steps",{"id":98,"label":99,"title":100,"body":101,"enforcedBy":102,"panelLabel":103,"panel":104},"end","Signed end","It ends one of two ways, and both are signed.","Closing or cancelling re-authenticates the person acting and writes a signature with the change request as its subject, in the same transaction as the status change. A rejected or sent-back review isn’t an end: it returns the change to draft.","server","Drawn from the close and cancel checks",{"kind":105,"outcomes":106},"outcomes",[107,116],{"status":108,"action":109,"from":110,"requires":111,"records":115},"closed","Close","Open",[112,113,114],"Every step on the route finished","Your role grants it on this change","An electronic signature","Signed against this change request, meaning “closed”",{"status":117,"action":118,"from":119,"requires":120,"records":122},"cancelled","Cancel","Draft or Open",[121,113,114],"A written reason","Signed against this change request, meaning “cancelled”, with the reason",{"id":124,"label":125,"title":126,"body":127,"panelLabel":128,"panel":129},"related","Linked by hand","What else it touches is linked as related.","A change request doesn’t keep a list of affected items. Link the documents, records and custom records it touches as related, and each link shows on both records.","What can be linked as related",{"kind":124,"types":130},[50,53,131,132,133,134,135,136],"Change request","Internal complaint","Quality event","Inspection lot","Document","Custom-module record",{"type":138,"id":138,"record":139,"facts":140},"contract","change request",[141,144,146,148],{"text":142,"enforcedBy":143},"A client can create a draft and nothing else. Every status change comes from the server.","db",{"text":145,"enforcedBy":102},"Close and cancel are both e-signed, with the change request as the signature’s subject",{"text":147,"enforcedBy":102},"A rejected or sent-back review returns the change to Draft, and it keeps its number",{"text":149,"enforcedBy":94},"Approval steps sign wherever your route demands it",{"type":151,"id":152,"focus":153,"eyebrow":154,"title":155,"blurb":156,"emptyTo":157,"relatedNote":158},"lineageRail","lineage-rail","change-request","Connected records","Where a change request comes from","Each link is stored, and visible from both records.","Nothing is created from a change automatically.","Any NC, CAPA, change request, internal complaint, quality event, inspection lot, document or custom-module record can also be linked by hand as related.",{"type":160,"id":160,"eyebrow":161,"title":162,"rules":163},"ledger","The rules, and who enforces them","What a change request won’t let happen",[164,167,170,173,176,179],{"rule":165,"detail":166,"enforcedBy":143},"Status moves only along its lifecycle","A trigger on the change requests table refuses any status change from a raw client, and any move outside the lifecycle from anyone. Cancelled has no way out.",{"rule":168,"detail":169,"enforcedBy":102},"No close while the route is running","Close is refused unless the change is open and every step on its route is finished. A scheduled effectiveness check is the one step allowed to run on.",{"rule":171,"detail":172,"enforcedBy":102},"No silent cancel","Cancelling needs a written reason and an electronic signature, and both stay on the record.",{"rule":174,"detail":175,"enforcedBy":102},"Closing and cancelling need the right","Your role must grant it on this change at its scope. At the narrowest scope, that is the change’s owner or initiator.",{"rule":177,"detail":178,"enforcedBy":102},"A register without gaps","The CR number is taken from a locked per-company counter on first submit, so two people can’t collide and an abandoned draft burns no number.",{"rule":180,"detail":181,"enforcedBy":143},"The history can’t be edited","Every change to a change request is written to the audit log by a database trigger, and the audit log refuses updates and deletions.",{"type":183,"id":183,"records":184,"sharing":185},"auditor","Change requests",{"eyebrow":186,"permission":187,"shareLink":188,"auditPackage":196,"notPackaged":200},"For your auditor","Only people with Manage Access on the module can share.",{"title":189,"points":190},"Share this record",[191,192,193,194,195],"Send it to anyone outside your company — no account needed.","They open it with a 6-digit code sent to their own inbox.","They see a read-only summary with its attachments, not your whole record.","The link expires after 30 days, and you can withdraw it at any time.","Every open is logged, so you can see who looked and when.",{"title":197,"titleAlone":198,"body":199},"Or bundle it for an audit","Bundle it for an audit","For an external audit, collect effective documents and quality records into one Audit Records Package — one link and one code for each auditor.","[records] aren’t included in the Audit Records Package — share them one at a time.",{"type":202,"id":202,"eyebrow":203,"title":204,"items":205},"faq","Straight answers","The questions a change board asks first",[206,209,212,215,218],{"q":207,"a":208},"Can a change request be edited while it is being reviewed?","Not in the app. The form is editable while the change is a draft. Once it’s open, a reviewer who wants something altered sends it back, which returns it to draft for the owner to fix and resubmit.",{"q":210,"a":211},"What exactly is signed?","Closing and cancelling, always. Each writes a signature against the change request, and a cancel carries its reason. Approval steps inside the route are signed too wherever the step demands it, as the approval step in the starting route does.",{"q":213,"a":214},"Does a change request list the documents it affects?","Not as a structured list today. Link the documents and records a change touches as related, and each link shows on both records. The record a change came from is linked automatically when you raise it from an NC or CAPA.",{"q":216,"a":217},"How does a CAPA turn into a change?","Raise the change request from the CAPA or the nonconformance. The link is written as the change is created, so the change carries its origin and the origin shows what it produced. Neither depends on someone remembering to mention the other.",{"q":219,"a":220},"Does the system track implementation after approval?","Yes, as sub-tasks on the change request’s own route, so the work sits on the record. Where a change needs its effectiveness proven, run that verification as a CAPA, which has a scheduled effectiveness check.",{"type":222,"id":223,"eyebrow":224,"title":225,"body":226,"action":227},"ctaPanel","cta","Proposed, reviewed, signed, closed","Show an auditor the change, and where it came from.","We’ll raise a change from a CAPA, run it through its review and sign it closed, with its origin on the record the whole way.",{"label":18,"href":19},[229,233,236],[230,231],"path",{"d":232},"M12 9v4",[230,234],{"d":235},"M10.363 3.591l-8.106 13.534a1.914 1.914 0 0 0 1.636 2.871h16.214a1.914 1.914 0 0 0 1.636 -2.87l-8.106 -13.536a1.914 1.914 0 0 0 -3.274 0",[230,237],{"d":238},"M12 16h.01",[240,243],[230,241],{"d":242},"M7 10h14l-4 -4",[230,244],{"d":245},"M17 14h-14l4 4",[247,250,253,256],[230,248],{"d":249},"M3 13a1 1 0 0 1 1 -1h4a1 1 0 0 1 1 1v6a1 1 0 0 1 -1 1h-4a1 1 0 0 1 -1 -1l0 -6",[230,251],{"d":252},"M15 9a1 1 0 0 1 1 -1h4a1 1 0 0 1 1 1v10a1 1 0 0 1 -1 1h-4a1 1 0 0 1 -1 -1l0 -10",[230,254],{"d":255},"M9 5a1 1 0 0 1 1 -1h4a1 1 0 0 1 1 1v14a1 1 0 0 1 -1 1h-4a1 1 0 0 1 -1 -1l0 -14",[230,257],{"d":258},"M4 20h14",[260,263,266],[230,261],{"d":262},"M9 5h-2a2 2 0 0 0 -2 2v12a2 2 0 0 0 2 2h10a2 2 0 0 0 2 -2v-12a2 2 0 0 0 -2 -2h-2",[230,264],{"d":265},"M9 5a2 2 0 0 1 2 -2h2a2 2 0 0 1 2 2a2 2 0 0 1 -2 2h-2a2 2 0 0 1 -2 -2",[230,267],{"d":268},"M9 14l2 2l4 -4",[270,273,276,279,282],[230,271],{"d":272},"M14 3v4a1 1 0 0 0 1 1h4",[230,274],{"d":275},"M17 21h-10a2 2 0 0 1 -2 -2v-14a2 2 0 0 1 2 -2h7l5 5v11a2 2 0 0 1 -2 2",[230,277],{"d":278},"M9 9l1 0",[230,280],{"d":281},"M9 13l6 0",[230,283],{"d":284},"M9 17l6 0",[286,289],[230,287],{"d":288},"M5 5a5 5 0 0 1 7 0a5 5 0 0 0 7 0v9a5 5 0 0 1 -7 0a5 5 0 0 0 -7 0v-9",[230,290],{"d":291},"M5 21v-7",[293,296,299,302,305,308],[230,294],{"d":295},"M12 3a3 3 0 0 0 -3 3v12a3 3 0 0 0 3 3",[230,297],{"d":298},"M6 3a3 3 0 0 1 3 3v12a3 3 0 0 1 -3 3",[230,300],{"d":301},"M13 7h7a1 1 0 0 1 1 1v8a1 1 0 0 1 -1 1h-7",[230,303],{"d":304},"M5 7h-1a1 1 0 0 0 -1 1v8a1 1 0 0 0 1 1h1",[230,306],{"d":307},"M17 12h.01",[230,309],{"d":310},"M13 12h.01",[312,315,318,321],[230,313],{"d":314},"M3 12a9 9 0 1 0 18 0a9 9 0 1 0 -18 0",[230,316],{"d":317},"M11 12a1 1 0 1 0 2 0a1 1 0 1 0 -2 0",[230,319],{"d":320},"M13.41 10.59l2.59 -2.59",[230,322],{"d":323},"M7 12a5 5 0 0 1 5 -5",[325,328,331],[230,326],{"d":327},"M18 4a3 3 0 0 1 3 3v8a3 3 0 0 1 -3 3h-5l-5 3v-3h-2a3 3 0 0 1 -3 -3v-8a3 3 0 0 1 3 -3h12",[230,329],{"d":330},"M12 8v3",[230,332],{"d":333},"M12 14v.01",[335,338,341,344,347,350,353],[230,336],{"d":337},"M5 21h14",[230,339],{"d":340},"M6 18h2",[230,342],{"d":343},"M7 18v3",[230,345],{"d":346},"M9 11l3 3l6 -6l-3 -3l-6 6",[230,348],{"d":349},"M10.5 12.5l-1.5 1.5",[230,351],{"d":352},"M17 3l3 3",[230,354],{"d":355},"M12 21a6 6 0 0 0 3.715 -10.712",[357,360,363],[230,358],{"d":359},"M6 4h11a2 2 0 0 1 2 2v12a2 2 0 0 1 -2 2h-11a1 1 0 0 1 -1 -1v-14a1 1 0 0 1 1 -1m3 0v18",[230,361],{"d":362},"M13 8l2 0",[230,364],{"d":365},"M13 12l2 0",[367,370],[230,368],{"d":369},"M20 11a8.1 8.1 0 0 0 -15.5 -2m-.5 -4v4h4",[230,371],{"d":372},"M4 13a8.1 8.1 0 0 0 15.5 2m.5 4v-4h-4",[374,377,380],[230,375],{"d":376},"M3 19a2 2 0 1 0 4 0a2 2 0 0 0 -4 0",[230,378],{"d":379},"M19 7a2 2 0 1 0 0 -4a2 2 0 0 0 0 4",[230,381],{"d":382},"M11 19h5.5a3.5 3.5 0 0 0 0 -7h-8a3.5 3.5 0 0 1 0 -7h4.5",[384,387],[230,385],{"d":386},"M22 9l-10 -4l-10 4l10 4l10 -4v6",[230,388],{"d":389},"M6 10.6v5.4a6 3 0 0 0 12 0v-5.4",[391],[230,392],{"d":393},"M3 17c3.333 -3.333 5 -6 5 -8c0 -3 -1 -3 -2 -3s-2.032 1.085 -2 3c.034 2.048 1.658 4.877 2.5 6c1.5 2 2.5 2.5 3.5 1l2 -3c.333 2.667 1.333 4 3 4c.53 0 2.639 -2 3 -2c.517 0 1.517 .667 3 2",[395,398,401],[230,396],{"d":397},"M5 17a2 2 0 1 0 4 0a2 2 0 1 0 -4 0",[230,399],{"d":400},"M15 17a2 2 0 1 0 4 0a2 2 0 1 0 -4 0",[230,402],{"d":403},"M5 17h-2v-11a1 1 0 0 1 1 -1h9v12m-4 0h6m4 0h2v-6h-8m0 -5h5l3 5",[405,408,411],[230,406],{"d":407},"M6 21v-2a4 4 0 0 1 4 -4h2",[230,409],{"d":410},"M22 16c0 4 -2.5 6 -3.5 6s-3.5 -2 -3.5 -6c1 0 2.5 -.5 3.5 -1.5c1 1 2.5 1.5 3.5 1.5",[230,412],{"d":413},"M8 7a4 4 0 1 0 8 0a4 4 0 0 0 -8 0",241564436]