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.
Selection of documentation offered :
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1.User Requirements Specifications
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2.Design Qualification Protocol
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3.Installation Qualification Protocol
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4.Operational Qualification Protocol
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5.Performance Qualification Protocol
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6.Re-Validation Protocols
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7.Validation Master Plans
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8.Functional Design Specifications
Equipment / Facilities Capabilities:
We have a stock of the following protocols prepared and ready for optimisation to meet your requirements;
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1.Autoclaves (Porous Load and Lab Units)
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2.Depyrogenation Ovens
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3.Freeze Driers
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4.Clean Rooms
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5.Incubators/Ovens
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6.Refrigeration Equipment
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7.Stability Cabinets
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8.Centrifuges
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9.Equipment Monitoring Systems (Wired/Wireless)
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10.Capping Machines
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11.Balances
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12.ph / conductivity meters
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13.Class II/LAF/Isolators