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IT Qualification Practice
Information Technology Capabilities
- RFP Development for IT Compliancy Projects
- Control
the Cost of IT Compliance
- IT Operational SOPs, Procedures,
and Validation Policies
- Compliant data transfer capabilities
with secured network implementation
- IT Infrastructure
implementation including FDA ESTRI Gateway
- PC desktop
image implementation and rollout in a regulated computing environment
- Compliance
based Web-based hosting with fully compliant hosting facilities
for GCP, and GLP based software applications
- IT hosting facility security audit
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Other Capabilities:
PharmaCIMS provides extended capabilities and
services in other diverse regulated areas. We deploy application
systems to help our customers to meet their corporate performance
and compliancy goals.
- Drug Safety and Medical Information Systems
- Clinical Trial application systems - Oracle
Clinical
- Adverse Events Tracking and Reporting
- WHO
Drug e-Dictionary
- HIPPA Compliance
- Electronic Data Capture including
Wireless Technology
- Bio-Statistical Analysis and Programming - SAS
Jobs
- PL/SQL, XML, Cold Fusion, JAVA, VBA, and EMC Documentum software application programming in a regulated environment.
- Report Application Development - Crystal
Reports, Report Writer, Brio, InfoMaker, Lotus Notes.
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Compliancy and Validation | Benefits | 21 CFR Part 11
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