How to Validate System Software According to GAMP Principles Industrial Manufacturing and Processes Life Science Environmental monitoring systems are considered an "automated system” by the Good Automated Manufacturing Practice (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE). These guidelines were created to help firms in GxP-regulated industries ensure function and compliance of software and computerized systems. In this webinar, Vaisala's Senior Regulatory Compliance Expert Paul Daniel describes how to validate monitoring system software according to best practices outlined in GAMP5. Included are several tools for ensuring your monitoring system validation aligns with the ISPE's guidelines. Use GAMP to Validate CMS, Vaisala Infographic 3.57 MB Using GAMP5 methods to validate your continuous monitoring system software1020.92 KB
Topics covered: How to develop a User Requirements Specification (URS) Document Steps to creating a Traceability Matrix Three different types of software systems and their validation processes: Off-the-Shelf, Configured, Custom How to create a Functional Specification Document (FSD), or obtain an adequate FS from a system vendor And more... Target Audience Regulatory Managers Metrology Managers Quality Managers Validation Managers Facility Managers Stability Managers Warehouse Managers Laboratory Managers Logistics Managers R & D Managers If you have already attended or registered for this webinar, please click here. Email Address*First Name*Last Name*Country*--Please Select--United StatesUnited KingdomCanadaChinaIndiaJapanAustraliaBrazilFranceGermanyFinland--------------AfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBrit/Indian Ocean Terr.Brunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo, The Dem. Republic OfCook IslandsCosta RicaCôte D'IvoireCroatiaCubaCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern Terr.GabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuineaGuinea-BissauGuyanaHaitiHeard/McDonald Isls.HondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsraelItalyJamaicaJapanJordanKazakhstanKenyaKiribatiKorea (North)Korea (South)KuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarN. Mariana Isls.NamibiaNauruNepalNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorthern IrelandNorwayOmanPakistanPalauPalestinian Territory, OccupiedPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarReunionRomaniaRussian FederationRwandaSaint Kitts and NevisSaint LuciaSamoaSan MarinoSao Tome/PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovak RepublicSloveniaSolomon IslandsSomaliaSouth AfricaSpainSri LankaSt. HelenaSt. Pierre and MiquelonSt. Vincent and GrenadinesSudanSurinameSvalbard/Jan Mayen Isls.SwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks/Caicos Isls.TuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUS Minor Outlying Is.UruguayUzbekistanVanuatuVatican CityVenezuelaViet NamVirgin Islands (British)Virgin Islands (U.S.)Wallis/Futuna Isls.Western SaharaYemenZambiaZimbabweState or Province*--Please Select--Other - not US or CAAlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutD.C.DelawareFloridaMicronesiaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMarianasMississippiMontanaNorth CarolinaNorth DakotaNebraskaNew HampshireNew JerseyNew MexicoNevadaNew YorkOhioOklahomaOregonPennsylvaniaRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUtahVirginiaVermontWashingtonWisconsinWest VirginiaWyomingAlbertaManitobaBritish ColumbiaNew BrunswickNewfoundland and LabradorNova ScotiaNorthwest TerritoriesNunavutOntarioPrince Edward IslandQuebecSaskatchewanYukon TerritoryCompany*Business PhoneI authorize Vaisala to send me information about relevant products and services. See our Privacy Policy for more details. You can modify your preference settings or unsubscribe at any time here
Webinar speaker Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn
Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn