Compliance & Validation

A proper Qualification/Validation process will improve system/ equipment performance and process yields and will assure that the final product meets all quality and repeat ability requirements defined by the regulator. The validation report is being audited and inspected frequently as part of regulatory bodies quality audits, as it has a direct impact on the final customer and patient’s health. ValiTech specializes in a board range of equipment and critical systems qualifications.

We provide an end-to-end solutions for ongoing operational activities and projects to small, medium and large companies that require engineering, project management, quality assurance, validations, and regulatory affairs consultation.

V-Model for Commissioning
& Qualification Process

V-Model is a project development and qualification life cycle schematic diagram that illustrates development phases and corresponding qualification activities to be performed for all new equipment and critical systems during project phases.


ValiTech is specializing on the following
equipment & systems

  • Steam / ETO / H2O2 / Superheated water spray sterilizers
  • Qualification of PSS (Purified Steam System)
  • Climate-Controlled Units
  • Visual inspection equipment
  • Depyrogenation Tunnels and Ovens
  • Vial washing machines
  • Tablet Coating machines
  • Tablet Presses
  • Parts washers
  • Compounding systems and vessels
  • Active PTC (Pass Through Chamber)
  • PFS and Vials filling machines
  • Packaging lines
  • VHP Isolators, Fume hoods, Bio safe cabinets
  • Encapsulation machines
  • WFI/PW
  • HVAC

Our validation services include

  • Validation Master Plans
  • Validation protocols (IQ/OQ/PQ)
  • Commissioning and Qualification (C&Q)
  • 21 CFR Part 11 Assessments
  • Design review, FAT, SAT for equipment and systems
  • Cycle development

Risk assessments:

  • Developing process mapping for new facilities
  • Fmea for a new equipment
  • Critical component assessments
  • Supplier assessments
  • Decommissionning assessments for equipment

Writing protocols and executing validation for:

  • Equipment and Critical systems
  • thermal validation
  • Cleaning validation
  • process validation
  • cold chain – Shipping validation
  • Facilities