Summary Report Template
IQ/OQ/PQ (DELETE WHERE APPROPRIATE)
SUMMARY REPORT Summary Report of the (add Title of Protocol Here) Your Logo Add Site Here
Ref: Here
Rev: 1
Page No
Protocol Execution Approval (Delete as app.) Name
Responsible
Signature
Date
Signature
Date
Author Quality and Compliance Manufacturing Regulatory
Protocol Approval (Delete as appropriate) Name
Responsible Author Quality and Compliance Manufacturing Regulatory
Introduction Add an Introduction of the Validation Here
Brief System Description
All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations. All testing will be performed retrospectively, prospectively, concurrently (delete as appropriate), and all tests will be in accordance with your company name here “Validation Policy – Validation Master Plan or Policy
Scope This protocol covers the Summary Report for the [Name Title Here]. The scope of this document is therefore limited to the testing for the equipment related to this and to assure that equipment is fit for use in accordance with cGMP. The report shall be reviewed and authorised by the stated personnel in the approval box prior to release of product/ use of equipment [delete where necessary].
Objectives The objectives of this Summary Report is to report findings throughout the protocol/s to ensure that the [Name Process Here] operates retrospectively, prospectively, concurrently [delete as appropriate] and is fit for use in accordance with cGMP and Health and Safety requirements.
Pre-requisites Summarise activities and tasks that must have been executed, been completed and approved. At a minimum, the following are pre-requisites:
The IQ/OQ/PQ protocol must be approved and executed and then reviewed and approved. All attachments in IQ/OQ/PQ must be complete and satisfactory, appended with references. All areas of IQ/OQ/PQ must be documented completely or written N/A (Not Applicable) where appropriate to GMP standards. All Information provided must be accurate and legible in Blue Ink Statistics (if provided) must be legible and explained) To supplement evidence of findings visuals such as photo’s or diagrams can be used throughout this summary.