OOrganized methodology for CSV with totally compliant ... · Electronic training certi˜cates...
4
E nterprise Quality Management AI enabled smart Enterprise Quality Management software solution; * helps develop enterprise wide culture of quality * for continued strong data integrity * maintaining overall compliance
Transcript of OOrganized methodology for CSV with totally compliant ... · Electronic training certi˜cates...
Enterprise Quality Management
AI enabled smart Enterprise Quality Management software solution;
* helps develop enterprise wide culture of quality
* for continued strong data integrity
* maintaining overall compliance
Reduced paper cost by 50%
Increased efficiency by 60%
Increased audit readiness by 40%
Easy adaptability
Enhances productivity
QEdge helps organisations manage their Quality Processes, Document Control and Employee training records on a single solution across multiple sites.
Part 11 (21 CFR Part 11, Annex 11) compliant AI enabled eQMS Enterprise wide implementation GxP audited – MHRA, US FDA, Health Canada, Others
Dashboard
Record/Field -level audit trails
MIS reports
Independent/Dependent processes
Features
SAP/ERPs, SharePoint
O365 pluginIntegration
eLearning
Training rooms
Employee dossiers
Training
Con�gurable processes
Dynamic work�ows
Process versioning
Processes& Control
Reduced paper cost by 50%
Increased efficiency by 60%
Increased audit readiness by 40%
Easy adaptability
Enhances productivity
Enterprise Quality Management
ChangeRequest
Deviation
CAPA
MarketComplaint
OOSOOT
Audit& Tracking
SOP
TrainingRecords
APQR
Speci�cation
Investigation
Fully validated Cloud ready Brings Auditreadiness
Ready-to-use con�gured quality processes
6th Floor, Arista, Anandnagar road, Ahmedabad 380015, India
+91-79-66214899 +44-208-432-6393 +1-847-307-5937
www.sarjen.com [email protected]
rims.sarjen.com
Track Label changesManage Submissions 'n Timelines Manage ApprovalsManage Query/sManage Product LicensesA step towards ISO IDMP...
ProcEdge RIMS - Regulatory information management
biznet.sarjen.com
eCRF, EDC and Clinical Data ManagementIWRS and Pharmacy ManagementMedical Imaging TrialsClinical Laboratory ManagementBioanalytical Laboratory AutomationeTMF
BizNET CTM - Clinical Research platform
Electronic Batch Records; eBMRseLogbookseLabNote booksDispensing managementManufacturing Execution (MES)
Process XE - Smart Manufacturing
process-xe.sarjen.com
Over 22 years' journey of IT consulting for business and technologyDomain expertise in Pharmaceutical, Life Science and other domainsSubject Expertise in SCM, CRM, SAP, QMS, PV, Clinical, eCTD and MESClient presence in 50+ countriesPartnerships with Microsoft, Apple, Amazon, AzureMembers of, Nasscom, Gesia, PharmexcilProprietary Technology StackPro�cient in cGxP, Part 11, GDPR complianceIn-depth knowledge of Computer System Validations (CSV)
Other GxP compliant solutions
About Sarjen
knowledgenet.sarjen.com
eCTD Publishing and Lifecycle viewerCTD/Paper SubmissionSPLISO IDMPSPOR DatabaseEstablishment Registration
KnowledgeNET - Dossier Publishing & Management
pvedge.sarjen.com
Human PV Safety DatabaseProduct Enquiry Trail and Response Veterinary VigilanceMultisource Case InboxEV Triage and InboxPV Training
PvEdge - Drug Safety Database
stacktrack.sarjen.com
Digitize physical �le storageE-repository for digital documentsManage physical binders & digital mediaCon�gurable work�ows & barcodes/RFIDs3D view of archival space
StackTrack - File Tracking System
