Computerized System Validation

Equipment & System Division

A great experience in qualifying pharmaceutical equipment and systems

Currently most of the pharmaceutical equipment is managed and controlled by computerized systems that have to be designed, developed and validated according to stringent quality standards defined by International Regulatory Bodies and Organizations like FDA, ISO and GAMP. Quality requirements impose the need for specific controls and procedures throughout the Software Development Life Cycle and the documented evidence, as stated by FDA, that Computer Systems will consistently produce results that meet its predetermined specification and quality attributed.

Acting in compliance with the most updated regulatory normative requirements, DOC has the Know-how and the Expertise to plan and execute Static and Dynamic Testing necessary for a successful Computer System Validation.

Considering the Validation of a new system, DOC can support users on:

Validation Planning and Definition

  • User Requirement Specification review
  • Validation Plan
  • Traceability Matrix
  • Risk Assessment
  • Vendor core documentation analysis and review

Validation Design

  • Functional Development Specification (FDS)
  • Hardware Design Specification (HDS)
  • Design Specification development
  • Mechanical and Electrical Specification development

Testing

  • FAT and SAT witnessing support
  • Qualification protocols (writing and execution) for Installation, Operational Qualification
  • Validation Report

 

Considering a system already in use, DOC can offer:

  • Documentation GAP analysis
  • Software Revalidation
  • Change Control Assessment
  • Data Integrity

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