Pharma IT Compliance

All critical IT processes (Formulations, R&D and API) are validated to ensure a consistency, transparency and compliance with Global Regulatory specifications.

We help companies to be in a state of “ready for inspection” in respect to global and regional regulatory bodies of IT requirements in applying security policies and controls.

Universal Technical Services offers the following Pharma IT Services but not limited to Establishing IT Security Controls and Procedures

  • Complete End to End IT Documentation & SOP Support
  • Data Backup Procedures and Process Improvements
  • Computer System Validations

Our expertise in IT Validations in Pharmaceutical Industry includes the custom-built solutions to complex systems such as manufacturing, packaging systems which includes PLC/SCADA/DCS or computerized Systems etc., and majorly with IT Infrastructure Qualification and Validations also.

We create the harmonized process and procedures to execute the validations protocols as below.

  • System Study
  • User Requirements Specification (URS)
  • GxP Assessment
  • 21 CFR Part 11 Assessment
  • Parameter Validation Assessment
  • Functional Risk Assessment (FRA)
  • Failure Mode Effects Analysis (FMEA)
  • Change Control (CC)
  • Project Validation Plan (PVP)
  • Functional Specification (FS)
  • Design Specification (DS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Data Migration (if any)
  • Validation Summary Reports
  • SOPs / Training Manual / Reports