The Validation Toolkit outlines the essential requirements as sought by both the FDA and the MHRA. A Validation system may have more components than what is provided here based on individual system requirements. For further assistance if you are unsure if this will suffice your requirements, please contact a consultant in the contact us page.
The Validation Toolkit is a comprehensive 100 page document which encompasses all your requirements for start up validations. Your company policy and approach to Validations will be clarified in the Validation Master Plan. You will then specify your request of any equipment is this toolbox is being used for new equipment purchase, for instances where equipment is already purchased you do not need to complete this stage. You will then outline individual Validation Plans for equipment, process and systems using the Validation Plan template.
Once all stages have been planned and documented the Installation Qualification must be written using the checklist provided in this toolbox. Following on from successful Installation you will need to check all your operational requirements and functionality and set parameters using methods such as Design of Experiments or an FMEA (Failure Mode Effect Analysis). You will need to ensure outer limits are established and documented here with objective evidence to support this. After successful OQ you will then need to perform a PQ, Performance Qualification using three consecutive batches with successful results. After you have completed your PQ, essentially you have covered all qualification requirements and you will need to summarise this using the summary report template provided in the toolkit.
Includes: Validation Master Plan, URS, Validation Plan, FAT, IQ, OQ, PQ, Summary Report.
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