{"id":11820,"date":"2021-09-07T08:45:06","date_gmt":"2021-09-07T06:45:06","guid":{"rendered":"https:\/\/www.agilelabs.co.za\/?page_id=11820"},"modified":"2021-09-07T08:45:36","modified_gmt":"2021-09-07T06:45:36","slug":"software-validation-testing","status":"publish","type":"page","link":"https:\/\/www.agilelabs.co.za\/af\/sagteware-validering-toetsing\/","title":{"rendered":"Sagteware validering en toetsing"},"content":{"rendered":"<p>Verseker nakoming op u plek<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Validasiebeplanning, toetsing en bestuur<\/h4>\n\n\n\n<p>Ons is kundiges in sagteware -nakoming. Alle weergawes van ProCalV5 -sagteware word intern getoets en gevalideer voor vrystelling. IQ\/OQ\/PQ protokolle kan voorsien word. GAMP 5 -vlak -validasieprojekplanne, alle nodige dokumente en die nodige dienste is beskikbaar om te verseker dat dit op u plekke voldoen. Gewone ontplooiings duur gewoonlik minder as agt weke.<\/p>\n\n\n\n<p><strong>Valideringsbeplannings-, toets- en bestuursdienste kan die volgende insluit:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>VMP (Valideringshoofplan)<\/li><li>Stel validasieverwagtinge, baie SDLC -pogings (System Development Life Cycle) is afhanklik van die VMP vir magtiging en leiding<\/li><li>Risikobeoordeling<\/li><li>Rasioneel vir vereistes Toets prioriteit<\/li><li>Toetsplan<\/li><li>Om die verwagtinge vroegtydig te toets, sodat die ontwikkeling van skripte met &#039;n duidelike doel begin kan word, om verkeerde rigting en verkeerde aanvang te vermy<\/li><li>Scripting<\/li><li>Hulpbronne<\/li><li>Ondersteuning vir toetsuitvoering<\/li><li>Afwykingsbesluit<\/li><li>VSR (Validation Summary Report)<\/li><li>Som toetsing, afwykings, resolusies en risiko -gebaseerde uitsonderings op<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Oorsig van QSR en GMP vir kalibrasieprogramme<\/h4>\n\n\n\n<p>By die implementering van &#039;n nuwe kalibrasieprogram in u sakebedrywighede, moet kwaliteit en nakomingspraktyke saam met die vervaardigingspraktyke in ag geneem word. Die onderstaande vrae kan u help om u doelwitte te organiseer.<\/p>\n\n\n\n<p><strong>Terme:<\/strong><br>GMP = Goeie vervaardigingspraktyke<br>QSR = Kwaliteitstelselregulasie<\/p>\n\n\n\n<p><strong>Waarom is toerustingkalibrasie deel van GMP\/QSR?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>&#039;N Vervaardiger moet &#039;n kwaliteitstelsel ontwikkel en implementeer wat verseker dat alle voltooide produkte voldoen aan die spesifikasies van die toestel se toestel\/geneesmiddel.<\/li><li>Versekering word op baie maniere verkry, insluitend die meting van komponent-, produk- en prosesparameters tydens ontwerp en vervaardiging.<\/li><\/ul>\n\n\n\n<p><strong>Wat is die verantwoordelikheid van die vervaardiger?<\/strong><\/p>\n\n\n\n<p>Om seker te maak dat alle produksie- en QA -toerusting, insluitend meganiese, elektroniese, outomatiese en chemiese toerusting, die volgende is:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Geskik vir beoogde gebruik<\/li><li>In staat om geldige resultate te lewer<\/li><li>Bedryf deur opgeleide werknemers<\/li><li>Behoorlik gekalibreer teenoor &#039;n geskikte standaard<\/li><\/ul>\n\n\n\n<p><strong>Wat is ingesluit in die prosedures?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Doel en omvang<\/li><li>Frekwensie van kalibrasie<\/li><li>Toerusting en standaarde word vereis<\/li><li>Grense vir akkuraatheid, presisie en vooroordeel<\/li><li>&#039;N Beskrywing van die kalibrasieproses<\/li><li>Remedi\u00ebrende aksie<\/li><li>Dokumentasie vereistes<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Doel en omvang<\/h4>\n\n\n\n<p>Kwaliteitsversekering moet bepaal watter metings nodig is om te verseker dat die ontwerp van die toestel\/geneesmiddel en die prosesparameters binne die vasgestelde spesifikasies vir akkuraatheid, presisie en vooroordeel is.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Frekwensie van kalibrasie<\/h4>\n\n\n\n<p>Dit hang af van die tipe toerusting, die frekwensie van gebruik en die kritiek daarvan in die vervaardigingsproses. Ander faktore wat die werking van toerusting kan be\u00efnvloed:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Temperatuur<\/li><li>Humiditeit<\/li><li>Besmetting<\/li><li>Statiese Elektrisiteit<\/li><li>Magnetiese velde<\/li><li>Kragtoevoer skommelinge<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Toerusting en standaarde<\/h4>\n\n\n\n<p>Alle toerusting en standaarde wat gebruik word, moet volledig beskryf word in die apparaat-\/geneesmiddelmeesterl\u00eaer of kwaliteitstelselrekords. Omgewingskenmerke soos temperatuur, humiditeit, vibrasies en netheid moet in ag geneem word by die kalibrering en gebruik van toerusting.<\/p>\n\n\n\n<p><strong>Toerusting<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Installasie -kwalifikasie (IK): aksie wat geneem is om te verseker dat toerusting en bykomende stelsels behoorlik ge\u00efnstalleer is, aan die vervaardiger se spesifikasies en ontwerpvoornemens voldoen, op die regte manier in die beoogde gebruiksgebied werk<\/li><li>Operasionele kwalifikasie (OQ): aksie wat geneem is om te verseker dat toerusting en substelsels konsekwent binne vasgestelde perke en toleransies kan werk<\/li><li>Prestasie -kwalifikasie (PQ): aksie wat geneem is om te verseker dat toerusting binne &#039;n stelsel oor tyd effektief en konsekwent presteer<\/li><\/ul>\n\n\n\n<p><strong>Toerusting en standaarde<\/strong><\/p>\n\n\n\n<p>Waar dit prakties is, moet standaarde herlei word na die National Institute of Standards en<br>tegnologie (NIST).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Privaat standaarde word vir kalibrasie na NIST gestuur en teruggestuur<\/li><li>NIST bied standaard naslaanmateriaal wat in die kalibrasieprogram gebruik kan word<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Grense vir akkuraatheid, presisie en vooroordeel<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>&nbsp;Akkuraatheid: die maatstaf van &#039;n instrument se vermo\u00eb om die ware of absolute waarde te verkry<\/li><li>Presisie: dui die relatiewe graad van herhaalbaarheid aan<\/li><li>Vooroordeel: &#039;n maatstaf van hoe naby die gemiddelde waarde in &#039;n reeks metings die werklike waarde nader<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Remedi\u00ebrende aksie<\/h4>\n\n\n\n<p>Dit vind plaas wanneer die perke nie nagekom word nie. Die remedi\u00ebrende maatre\u00ebls moet die volgende bepalings insluit:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Beskryf en begin enige aksie wat nodig is om die perke te herstel (herkalibrasie)<\/li><li>Evalueer of daar &#039;n nadelige uitwerking op die kwaliteit van die toestel\/geneesmiddel is<\/li><li>Dokumenteer alle uitgevoer aksies en evaluerings<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Dokumentasievereistes<\/h4>\n\n\n\n<p>Papierstelsel of sagtewareprogram:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Toerusting -identifikasie (modelnommer ingesluit)<\/li><li>Reeksnommer<\/li><li>Kalibrasie datum<\/li><li>Kalibrator se naam<\/li><li>Datum van volgende kalibrasie<\/li><li>Kalibrasie spesifikasies<\/li><li>Adres van MFR (opsioneel)<\/li><li>Rede vir kalibrasie (opsioneel)<\/li><li>Kommentaar (opsioneel)<\/li><li>Buitendienste -inligting (opsioneel)<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Kalibrasiepersoneel<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Moet voldoende opgelei word deur opleiding en\/of ervaring om kalibrasies uit te voer.<\/li><li>&#039;N Basiese kennis van metrologie- en kalibrasiebegrippe moet h\u00ea<\/li><li>Begryp die basiese beginsels van meetdissiplines, verwerkingsstappe en aanvaardingsvereistes<\/li><li>Kennis van die algehele kalibrasieprogram<\/li><li>Die vermo\u00eb om instruksies rakende onderhoud en gebruik van toerusting te volg<\/li><li>Gewetensgesindheid<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Bevestiging van nakoming<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Oudit van die kalibrasieprogram<\/li><li>Interne oudits (vereis deur QSR)<\/li><li>Die handhawing van &#039;n geskikte skedule<\/li><li>Handhawing van behoorlike dokumentasie<\/li><li>Geskikte instandhouding van standaarde<\/li><li>Toereikendheid van regstellende aksies<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Eksterne oudits<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>FDA beskou kontraklaboratoriums as &#039;n uitbreiding van die vervaardiger se GMP -program, sodat periodiek dit toepaslik is<\/li><li>Verkry dokumentasie wat bevestig dat toerusting onder gekontroleerde toestande gekalibreer is met behulp van naspeurbare standaarde<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Bykomende kommer<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Vervaardigingstoerusting wat in die produksieproses gebruik word (indien outomaties) moet periodiek gekalibreer word<\/li><li>Vervaardigingstoerusting wat deur die rekenaar beheer word, moet vir die beoogde gebruik daarvan bekragtig word en by &#039;n kalibrasieprogram ingesluit word<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Byvoeging van definisies<\/h4>\n\n\n\n<p><strong>Installasie kwalifikasie (IK):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Het jy gekry wat jy wou h\u00ea?<\/li><li>Het u die regte fasiliteite om dit te gebruik?<\/li><li>Is al die toerusting behoorlik verantwoord:<ul><li>Reeksnommer<\/li><li>Vervaardiger<\/li><li>Huis se bate nommer<\/li><li>Behoorlike installasie<\/li><li>Instrument logboek in plek<\/li><li>Lab -ligging<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Operasionele Kwalifikasie (OQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dokumentasie wat die laboratoriumtoerusting verifieer, presteer oor die verwagte gebruiksreekse<\/li><li>Reeks funksionele toetse om te verseker dat &#039;n instrument\/stelsel volgens die perke van &#039;n voorafbepaalde stel kriteria werk<\/li><\/ul>\n\n\n\n<p><strong>Prestasie -kwalifikasie (PQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dui aan dat &#039;n spesifieke stel metodeparameters behoorlik werk ten opsigte van die historiese metodevalidering<\/li><li>In sommige gevalle kan stelselgeskiktheid as prestasie -kwalifikasie aanvaarbaar wees<br>Herkwalifikasie (RQ):<\/li><li>Bepaling dat &#039;n instrument, na herstelwerk, verskafferdiens, liggingverandering of aanpassings gemaak is, werk soos verwag en bedoel<\/li><li>Oorwegings<ul><li>Voldoen die instrument aan die oorspronklike protokolle wat daargestel is?<\/li><li>Indien nie, watter besluite moet geneem word?<\/li><\/ul><\/li><\/ul>","protected":false},"excerpt":{"rendered":"<p>Ensure Compliance At Your Location Validation Planning, Testing And Management We are software compliance experts. All versions of ProCalV5 software are internally tested and validated before release. IQ\/OQ\/PQ protocols can be provided. GAMP 5 level validation project plans, all necessary documents and any needed services are available to ensure compliant use at your locations. 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