Argus Fast Track Implementation and Upgrade
RxLogix Argus safety solutions are delivered in a highly optimized way, to accomplish Argus implementations and upgrades with exceptional efficiency. Leveraging industry best practices, highly standardized project life cycle and an exceptionally skilled Argus team, the Argus implementation and upgrade projects are executed for on-time, to-plan and to-budget delivery. RxLogix is a certified Oracle Argus safety partner.
RxLogix team members designed industry’s first FastTrack methodology and toolsets. RxLogix team also delivered industry’s fastest Argus Japan implementation for a Top 50 global pharmaceutical company.
Get RxLogix high performing team, who helped build Argus from its v1.0 release, to the v 8.1 upgrade. Get it right the first time!
What is New in Argus 8.x ?
- E2B R3 Global Compliance
- eMDR Related Changes
- eVAERS Related Changes
- Global Lock & Local LockICSR Validation Framework.
- Authoring of Periodic Reports using Oracle BI Publisher.
- Support of Oracle B2B gateway in addition to Axway.
- Support of WHO Drug B3/C3 Dictionaries
Tangibles and Intangible benefit you get when you use RxLogix Argus FastTrack Implementation Proven Methodology
- Highly standardized project life cycle and methodology
- Standard set ofdeliverablesforfast track implementation and upgrades of both Argus Global and Argus Japan for on-time/to-plan/to-budget delivery:
- Project Plan
- Validation Plan
- Risk assessment, Validation strategy and planning
- Validation scripts authoring (IQ, OQ, PQ)
- Test execution & Summarization
- Validation Protocol
- Validation Summary Report
- Requirement Documents (URS/FRS)
- Impact Assessment Matrix
- Design Document (CSD/Environment Architecture)
- Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) Scripts (Manual & Automated)
- Standard set of Regression Test Scripts (Manual & Automated)
- Traceability Matrix
- User Training (English/Japanese)
- End user training
- Advanced user training
- Business administrator training
- System administrator training
- Best Practice Templates/Configurations
- Narrative Templates
- Letter Configurations
- E2B Profile Transmission/Import Customizations
- Business Process/Workflow Configurations
- Pre/Post Save Functions
- Configuration workshops
- Conference Room Pilots
- SOP Updates
- ETL Design
- Analysis, Design & Development of custom reports (OBIEE, BIP, Cognos, Business Objects, Spotfire, Qlikview and Tableau)
- Standard Project Plan
- Fixed project scope for no-surprise scope management
- Fixed schedule for a more rapid and well controlled project execution
- Fixed team members, assigned in advance, for the project duration, with no team changes surprises
- Fixed Price project budget for a highly competitive and strict fiscal control pricing
- Integration with various interfaces –
- Experts with integration experience in Clinical Systems, Product Complaint Systems,
- Dictionary Management Systems etc.
- Gold configurations of Argus Safety 8.x suite are readily available to accelerate delivery of solution and implementation of global best practices.
- Extensive expertise on regulations and complex E2B R3 Transition and IDMP programs
- StandardCloud based service solutions.
- Database Administration and Optimization
- E2B gateway / pilot testing support
- E2B R3 Converter and EMA Plug In
- Disaster Recovery Planning & Testing
- Cutover / Hypercare planning & rollout
- RxLogix FastTrack Implementation and managedservicesteamhasbilingualcapabilities, is geographically located thus providing both onshore and offshore services
- Issues, enhancements, or queries managed to completion
- Facilitate adherence to SLAs agreed with business
- End-to-end service management
- RxLogix FastTrack Implementation methodology provides out of the box integration with the other industry solutions-Medidata Rave, Inform etc.
- Pharma/Biotech focused, best practices solution.
- Guaranteed fixed price and fixed timelines delivery
- Significant reduction in need of already scarce business resources time for project implementation efforts
- Boots on the ground, who are highly customer focused.
- Implement RxLogix developed Validation package for faster implementation or Upgrade to Oracle Argus Safety v8.1.2 and get insight to upcoming Argus versions planning ahead
- Minimum maintenance efforts post Go-live
- Unlimited access to SME pool:
- Argus SMEs - Pool of experienced Argus SMEs (Who were part of initial release of Argus 1.0 to 8.1.2 team)
- Axway SMEs - Axway configuration experts with experience in configuring/validating submissions to FDA, EMA and PMDA
- Solution Architects - Skilled Solution Architects who have experience in converting the business needs into solutions
- Multilingual Team.
- Reporting SMEs (OBIE/Cognos/Business Objects) - Reporting SMEs with in-depth knowledge of data marts and designing custom reports in any standard reporting tool