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Select service which you require

Documentation services

We can design bespoke or supply from our large library, validation documentation to support GMP equipment/facilities qualification.

From consulatation to final approvals, contact us for a no obligation quote.

All documentation has been prepared with unambiguous text to ensure regulatory compliance. These documents have been reviewed by QP’s, MHRA auditors and QA Directors – all with positive feedback.

Below is a list of documentation types we can supply off-the-shelf or design to your requirements.

doc

Selection of documentation offered :

  • 1.
    User Requirements Specifications
  • 2.
    Design Qualification Protocol
  • 3.
    Installation Qualification Protocol
  • 4.
    Operational Qualification Protocol
  • 5.
    Performance Qualification Protocol
  • 6.
    Re-Validation Protocols
  • 7.
    Validation Master Plans
  • 8.
    Functional Design Specifications

Equipment / Facilities Capabilities:

We have a stock of the following protocols prepared and ready for optimisation to meet your requirements;

  • 1.
    Autoclaves (Porous Load and Lab Units)
  • 2.
    Depyrogenation Ovens
  • 3.
    Freeze Driers
  • 4.
    Clean Rooms
  • 5.
    Incubators/Ovens
  • 6.
    Refrigeration Equipment
  • 7.
    Stability Cabinets
  • 8.
    Centrifuges
  • 9.
    Equipment Monitoring Systems (Wired/Wireless)
  • 10.
    Capping Machines
  • 11.
    Balances
  • 12.
    ph / conductivity meters
  • 13.
    Class II/LAF/Isolators

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Biocity Scotland
Bo'Ness Road, Newhouse
ML1 5U

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