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The Gap Analysis Template can be used as a guide to assist in site inspections/audits for Medical Device manufacture.
A 3-page preview of the Gap Analysis Report Template is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The Laminar Air Flow IOPQ is essentially a Installation and Performance Qualification with a rationale for OQ, where is most systems there are no settings to challenge that can affect the overall integrity of performance.
A preview of the the IOPQ Validation Protocol is available here:
You may purchase the full 25 page document in convenient Microsoft Word format including instructions for use below.
This is a combination of the IQ, OQ and PQ. You can use this for a full qualification, add or remove any sections as you require.
A 5-page preview of the Installation, Operational and Performance Validation Protocol is available here:
You may purchase the full 35 page document in convenient Microsoft Word format including instructions for use below.
This is a combination of the IQ and OQ, add or remove any sections as you require. The combined qualification has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment.
A 7-page preview of the Installation, Operational Validation Protocol is available here:
You may purchase the full 26 page document in convenient Microsoft Word format for use below.
This is a combination of the OQ and PQ, add or remove any sections as you require. The combined qualification has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment.
A 6-page preview of the Operational & Performance Validation Protocol is available here:
You may purchase the full 19 page document in convenient Microsoft Word format for use below.
The Validation Toolkit is the answer to those who are either new to Validation, or those who want a simplified start to a validation approach. Pharmi Med Validations have used all their experience to piece together the essential components of a successful Validation system for both Medical Device and the Pharmaceutical industries; this toolkit will work.
A 16-page preview of the Validation Toolkit is available here: