oorganized methodology for csv with totally compliant … · 21 cfr part 11 and eu annex 11...
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SOP managementSpeci�cation managementReports managementControlled copy release
Training record keepingTraining Gap, Need,Scheduling
Change ControlDeviationInvestigationCAPAProduct ComplaintOOSOOTAudit management
QQuality Processes
DDoc Control
TTraining Records
Quality Processes . Doc Control . Training Records
www.qedge.co.in
uality
21 CFR part 11 and EU Annex 11 compliance (GAMP 5 adherence for CSV approach)PIC/s and AGIT guidance on CSVSuccessful implementations at US FDA, MHRA and TGA approved facilities
OOrganized methodology for CSV with totally compliant deliverance…
For complete quality processes management across varied industries
In-built spell checkAutomated escalation of assigned actionsAuto scheduling, alerts of overdue reportsEasy tracking of quality events and risksMetrics reports, trend chartsKPI reports to top managementIntegration with ERPs – SAP, SharePoint, etc.
Quality Processes
Internal/External Audit
Recall
MarketComplaint
Deviation
Investigation
Qualityreview
Out ofSpeci�cation
Out of TrendCAPA
ChangeControl
Qual
ity P
roce
sses
Doc C
ontr
ol
Management of training, tracking, scheduling
E�ective management, tracking,release of quality related documents
Identify Training needs and Training gapsEasy tracking/scheduling/reschedulingCentralized storage to manage all the training metricsOnline access to employees’ training performance metricsElectronic training certi�catesDocument upload in employee document dossierInduction, classroom, Self and Practical,Functional trainingDetails of required, completed, overdue andupcoming trainings
Create
Trai
ning
Man
agem
ent
Review
Approve
PublishControlled
Copyrelease
Automated life cycle of various documentsWatermark and Introductory pageEnsured document assignment to relevant groupsSecure access for the administrator to update SOPsDocument/Release versioningCentralized document repositoryPeriodic review alerts and noti�cationsEasy integration with ERPs - SAP, Sharepoint, TMS, Others
KnowledgeNET - Dossier Publishing SolutionKnowledgeNET - Dossier Publishing Solution
KnowledgeNET is a robust, featured-packed, well established dossier submission and life cycle management solution. It has great adaptability of compiling dossiers with various global regulatory standards in distinct publishing formats like CTD, eCTD, NeeS, ACTD, GTD, vNeeS and the regional formats.
knowledgenet.sarjen.com
PharmaNET - Sales and DistributionPharmaNET - Sales and Distribution
Sales and distribution solution with Demand, Warehouse, Financial, Purchase & Material Management…Also, tracks Primary and Secondary sales channels to provide a consolidated picture of dispersed and complicated analysis.
pharmanet.sarjen.com
PvEdge - Drug Safety DatabasePvEdge - Drug Safety Database
3600 pharmacovigilance solution which covers Post marketing, Clinical, Medical devices, Vaccine, Veterinary Pharmacovigliance.Enabled with Literature automation and Signal detection modules, Ethics committeefunctioning and SAE management, xEVMPD and Product License management.
pvedge.sarjen.com
FForce - Field Sales Excellence Platform
Distribution Management SystemElectronic Order Management SystemSales Force Automation SystemeDetailingField Sales Information System
FForce - Field Sales Excellence Platform
�orce.sarjen.com
ProcEdge - Business Process Automation
Processes automationWork�ow automationDocument management
ProcEdge - Business Process Automation
procedge.sarjen.com
Process XE - Electronic Batch Records
Covers entire cycle starting from MPCR preparation to approved BPCR archivingManaging related SOPs, equipments’ validation and calibration statusCompatible with devices and OS - helps in utilizing Process XE on shop �oor
Process XE - Electronic Batch Records
BizNET CTM - Clinical Trial ManagementBizNET CTM - Clinical Trial Management
Complete Clinical Trial management for CROs with Project tracking and monitoring, eCRF/EDC, Biometric volunteer registration, Medical screening, Medical coding, Clinical LIMS, BA LIMS…
biznet.sarjen.com
Othe
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arjen
ISO 9001:2015 certified company
6th Floor, Arista, Anandnagar road, Ahmedabad 380015, India
+91-79-66214899 +44-208-432-6393 +1-847-307-5937
www.sarjen.com [email protected]
Over 19 years' journey of IT consulting for business and technologyDomain expertise in Pharmaceutical, Life Science and other domainsExpertise in SCM, CRM, QMS, PV and Dossier Publishing solutionsClient presence in 40+ countries; mainly in UK and rest of EuropePartnerships with Microsoft, Apple, HP, IBMSolutions built with own IP; adoptable to meet business challengesSolutions compliant with 21 CFR part 11, Annex 11 and GxPIn-depth knowledge of Computer System Validations (CSV)
process-xe.sarjen.com