Part 11 Remediation Plan Template - Sample

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Part 11 Remediation Validation Part 11 Remediation Plan for [xxxxx] Add Site Here

Ref: _________

Rev: 1

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Approval Name

Responsible Author Quality and Compliance Manufacturing

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Signature

Date


Test One) Formula Challenges Objective

To ensure any formulas complex or simple can be challenged and proven to ensure that the spreadsheet being validated is accurate and providing the correct information

Acceptance Criteria

All Acceptance Criteria detailed below must be met

Method 1. Note all the formulas in the spreadsheet and their purpose 2. Challenge each formula by changing it and ensure the result is inaccurate 3. All interdependent calculations will need challenge testing therefore all formulas with look up tables and other dependant fields will need challenging. 4. Using a calculator work out the end result and compare this against the formula calculation for verification – repeat this for three rows 5. After Challenging the formula and passing the acceptance criteria apply Test Two a) to f) where applicable and ensure the data is protected and cannot be manipulated, apply all secure controls as per these tests. Note – the number of challenges was not based on any statistical sample, this was due to confidence in the MS office Excel software. Acc. Criteria - Result in the appointed field is False

Protocol Number: VP-PR-IQ-001 Page 22 of 15

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