Computer System Validation

PAATAM Technologies has provided "Computer System Validation" services to a number of world class pharmaceutical companies and can deliver that same world class service to your company. Computer System Validation services may be provided a-la-cart or as a turn-key solution including project management as required by the client. Services include the following validation deliverables:

  • Quality Assurance/Validation Plans
  • User Requirement Specifications
  • Functional Requirement Specifications
  • Detailed Design Specifications
  • Vendor Audit Reports
  • Master Test Plans
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • User Acceptance Test (UAT) documents
  • Process Qualifications
  • Testing Execution
  • Test Summary Reports
  • Training Plans
  • Quality Assurance/Validation Summary Reports
  • SOPs, Guidelines

Capabilities:

  • The PAATAM Technologies staff has performed validation services on the following systems in regulated companies in accordance with FDA regulations and SDLC procedures:
  • Control systems for sterile/biotech equipment/systems including Lyophilizers, Sterile/Bioreactors, filter systems, Filter Integrity Test Systems, Pressure/Temperature Controls, Packaging Systems and Environmental controls.
  • Laboratory systems including Ovens, Coolers, Freezers environmental controls, Chromatography Data Collection Systems, Lab Instrumentation, Laboratory Information Management Systems (LIMS), including Sample Manager LIMS, Watson LIMS, Beckman LIMS, Win LIMS, SQL *LIMS, Labvantage LIMS.
  • Other instruments validated include: UV-Vis spectrometers, FT-IR, FT-NIR spectrometers, NMR, High Performance Chromatography (HPLCs), Gas Chromatographs (GCs), and capillary HPLCs.
  • Information Management Systems including Electronic Documentation Management Systems (EDMS) including Documentum 4i, iXOS, Excel Spreadsheets, Maintenance Management Systems (MMS), Manufacturing Resources Planning system (MRP II), Enterprise Resource Planning system (ERP), Order Management Systems (OMS), Supervisory Control and Data Acquisition Systems (SCADA) and Manufacturing Execution Systems (MES).

 

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