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

 

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.

Compliancy and Validation | Benefits | 21 CFR Part 11

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