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Audit Management Software Systems

Qualityze’s Audit Management Software allows you to plan, schedule and conduct an audit of any kind,With our end-to-end functionalities we help you to complete audit lifecycle - from audit planning and scheduling and track findings, performing all follow ups for industries across Pharmaceuticals, Manufacturing, Banks, Life Sciences, Hospitals and Healthcare.

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Audit Management Software Systems

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  1. Datasheet Qualityze Audit Management Solution Plan, Schedule, Execute, Manage Finding, Track yourAudits Asweknow,regulatoryrequirementsarebecomingmorestringent,andthecostofcomplianceisgrowing.Atthesame time, audit management is becoming increasingly challenging, given the number and types of audits that need to be conducted. Qualityze Auditing Management software (QAM) complements your established audit management process and empowers you to improve quality, reduce costs and identify operational and compliance risks by effectivelymanagingthefullauditlifecycleby, AuditPlan The audit plan is an important step in the auditing process. It serves the auditors to define the objective, scope, criteria, location, and the establishment ofoverall auditstrategy. The audit management system of Qualityze helps to streamline the audit plan. You can use the Audit Type template to define informationsuch as, Auditors and the auditees Audit Start/End date Predefined auditquestionnaire Auditstandards Audit Criteria andothers Prepare and ExecuteAudit In this step the lead auditor will confirm and/or update the audit. The auditee and auditor will agree on the objective, scope, criteria and start date of the audit process.InQualityze,oncetheAuditType,AuditProgram is developed, the system will automatically notify you in advanceforyoutopreparefortheaudit. Title, Scope of the audit Objective of the audit Audit Criteria, Checklist Lead Auditor, AuditTeam Location, Type of Audit Owner andothers TrackFindings During theaudit, observations are recorded and nonconformance needs to be tracked to completion. Observations are categorized in threeterms: Findings,PositivePractices,andRecommendations.The system gives you the capability to define these observations at an individual questions level also. When you categorize observation as Findings, you have an option to follow the workflow to address it. Every Findings is assigned a unique number for you to keep trackoffuntilitisclosed. AuditSchedule The audit schedule is a specification of the planned activities that will occur over certain period (e.g. yearly, halfayear).Mostofthecompanywilldevelopanannual scheduleusuallyforinternalandsupplierauditprogram. In Qualityze, Audit Program (AP) will help you to setup a yearly plan for internal and supplier audit program in conjunction with Audit Type. In the Audit Program, you candefine,

  2. Qualityze Nonconformance Management Software Ensuring ISO 9001 & RegulatoryCompliance Capabilities Benefits Industry BestPractices Implement your Audit with an industry-proven processes to improve your product and process quality Centralized DeviationDatabase TrackallyourqualityAuditrecordsinavalidatedsystemwithdetailedaudittrailforaregulatory environment RiskAssessment Assess the risk of the event and evaluate for need of CAPA using system driven Risk Priority Value(RPV) An electronic signature for every action and decisions performed. Includes the name of the signatory,thedateandtimeofsignatureexecution Electronic or DigitalSignature Dashboards &Reports Users can create any number ofDashboards and reports. The color-coded icons quickly help the user know “WHERE AM I” in the managed workflow process. Iconic Color CodeManaged WorkflowProcess Proactiveinputvalidationhelpsguidetheuserwhilereducingerrorsonlatersteps Proactive InputValidation Multiple files of any type can be attached to an Audits and filesare identified by steps of the process FileAttachments Automated DynamicWorkflows Dynamicworkflowconfigurationallowsusertocreatevariationsofworkflowfor every Audit FollowfeatureallowsusertokeeptrackonprogressoftheAuditthattheyareinterestedin,even thoughtheydonotownorhaveanyactivetask.Thesystemwillcreateanalertonthedashboard anytimetheAuditrecordsthattheyarefollowingisupdated. Followorsubscribetoyour important qualityrecords Dynamicportalpageprovidesaquickoverviewofallthetasksforausertocomplete.Approval, TaskCompletion,Alerts,Notes,FollowedAuditsandAuditsthattheuserownsarealldisplayed in the portalpage. Notes for importantreminders Alerts &Notifications A content change notification service that provides information in the homepage anytime any typeofupdatesoccurstoanAuditrecordsthattheuserown. PortalPage Dynamicportalpageprovidesaquickoverviewofallthetasksforausertocomplete.Approval, Task Completion, Alerts, Notes, Followed NCs and NCs that the user owns are all displayed in the portalpage. With task list approval, approver will have the capability to approver right from the task list withouthavingtogointothedetailoftherecord. Task ListApproval With this feature, approver do not have to sign into the application to approve. User can simply reply back with words like ‘APPROVE’, ‘APPROVED’, ‘REJECT’, or ‘REJECTED’, as aresponse. Outlook EmailApproval Chronology Every Audit records have a timeline of an event which tells the user what happened when. In other word a very high level audit trail that allows user to quickly understand the sequence of activitiesthatoccurredinthelifecycleofAuditrecord. QualityzeInc. 3903 Northdale Blvd Suite 100E-36 Tampa - FL 33624 Phone: +1-877-207-8616 Email:info@qualityze.com www.qualityze.com

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