Compliance and Validation Services

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COMMITMENT

photo: training situation

Computer Validation

PharmaSys has provided "computer validation" services to a number of world class pharmaceutical companies and can deliver that same world class service to your company. Computer 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:

  • Quality Assurance/Validation Plans
  • Functional Requirements Specifications
  • Detailed Design Specifications
  • Installation Qualifications
  • Operational Qualifications
  • Performance Qualifications
  • Process Qualifications
  • Testing Execution
  • Summary Reports
  • SOPs, Guidelines
  • 21CFR Part 11 Assessment and Remediation
  • Audits

Capabilities

The PharmaSys staff has performed computer validation services on the following systems:

  • Network Validation including firewalls, routers, switches, layout, cabling, security
  • 21CFR Part 11 Audits, Assessment, Remediation, SOPs and Training
  • 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, laboratory information systems (LIMS), chromatography data collection systems and instrumentation. Other instruments validated include: UV-Vis spectrometers, FT-IR spectrometers, high performance liquid chromatography (HPLCs), gas chromatographs (GCs), and capillary electrophoresis systems (CEs).
  • Information management systems including electronic documentation management systems, laboratory information management systems (LIMS), maintenance management systems (MMS), manufacturing resources planning system (MRP II, ERP), order management systems (OMS), supervisory, control and data acquisition systems and (SCADA) systems and manufacturing execution systems (MES).
  • Bulk pharmaceutical manufacturing processing trains including reactors, blenders, centrifuges, dryers, temperature controls, vacuum/pressure controls, dispensing controls, and automated sequences.
  • Distributed Control Systems (DCSs) used to control and monitor environmental, bulk, secondary and sterile processes.
  • Programmable Logic Controllers (PLCs) utilized to control pharmaceutical process equipment.
  • Database management systems including Oracle, Sybase, MS SQL server, DB/2, and MS Access.
  • Computerized Clinical Data Acquisition and Management Systems.
  • Solid dosage, ointments, creams, liquids and sterile packaging lines including check weighers.
  • Pharmaceutical blenders, mixers, granulators, dryers, tablet coating systems and tablet presses.


If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.


 
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