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How do you perform gap analysis and remediation for existing or legacy equipment?

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Validation acceptance criteria (VAC) are the measurable and testable specifications that define the expected performance and quality of a piece of equipment or system. They are essential for ensuring that the equipment meets the regulatory and operational requirements and can deliver consistent and reliable results. In this article, we will explain how to perform gap analysis and remediation for existing or legacy equipment that may not have clear or updated VAC.

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1 What is gap analysis?

Gap analysis is the process of comparing the current state of the equipment with the desired state based on the VAC. It involves identifying and documenting any gaps, deficiencies, or non-conformities that may affect the equipment's functionality, safety, or compliance. Gap analysis can be performed at any stage of the equipment lifecycle, but it is especially important for existing or legacy equipment that may have been installed or modified without proper validation or documentation.

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2 How to conduct gap analysis?

To conduct gap analysis, you should review the equipment history, design, and configuration. Gather all relevant information and records, such as user requirements, functional specifications, drawings, manuals, calibration certificates, maintenance logs, change controls, and previous validation reports. Then define the VAC for the equipment based on its intended use and purpose. Compare the current state with the VAC to assess the equipment's performance and quality against the standards. Identify any gaps or deficiencies that may prevent the equipment from meeting the VAC and determine their root cause, impact, and risk level. Finally, prioritize and plan the remediation actions to close the gaps and ensure the equipment meets the VAC. Develop a remediation plan that defines the scope, timeline, resources, responsibilities, and verification methods for each action.

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3 What is remediation?

Remediation is the process of implementing the actions that are necessary to close the gaps and ensure the equipment meets the VAC. It involves correcting, improving, or enhancing the equipment's functionality, quality, or compliance. Remediation can be done by the equipment manufacturer, supplier, owner, or user, depending on the nature and severity of the gaps and the contractual agreements.

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4 How to perform remediation?

To perform remediation, you need to execute the remediation plan that was developed based on the gap analysis results. Make sure to carry out the remediation actions according to the defined scope, timeline, resources, responsibilities, and verification methods. Document all activities and results in detail. After completing the remediation actions, verify that the equipment meets the VAC. Conduct tests, inspections, or audits to confirm that the gaps have been closed and the equipment's functionality, quality, and compliance have been improved or restored. Update the equipment documentation based on the remediation and verification results. This documentation may include user requirements, functional specifications, drawings, manuals, calibration certificates, maintenance logs, change controls, and validation reports.

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5 How to maintain the equipment compliance?

After performing gap analysis and remediation for existing or legacy equipment, it is important to maintain the equipment compliance with the VAC throughout its lifecycle. To do this, regularly monitor and control the performance and quality of the equipment, checking and measuring its functionality, safety, and reliability against the VAC. Record and analyze any data and trends that appear, addressing any deviations or issues as soon as possible. Additionally, follow the manufacturer's or supplier's recommendations for preventive maintenance and calibration of the equipment or its components. Make sure that any maintenance and calibration activities are performed by qualified personnel and documented properly. Whenever there is a change in the equipment's design, configuration, location, use, or environment, assess the impact of the change on the VAC by following a change control procedure that defines the approval, implementation, and verification steps. Revalidation may be necessary to confirm that the equipment still meets the VAC after any changes have been made.

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Greg Weedon

I Help Quality Professionals Look good to their boss.
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I call this Intermediate Standard checks. Monthly I control chart a few key parameters so I have a fall back check point. So in the event the standard fails full calibration I have a checkpoint.

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How do you perform gap analysis and remediation for existing or legacy equipment?

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1 What is gap analysis?

2 How to conduct gap analysis?

3 What is remediation?

4 How to perform remediation?

5 How to maintain the equipment compliance?

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