Equipment Integration & Validation
New Solutions & Equipment Qualification
Organizations can avoid ineffective equipment or solution purchases by defining validation protocols and conducting qualifying tests. This assures the installation and operation of the equipment fully complies with the needs of the organization and that it fully integrates into the process of delivering care.
Validation is a collaborative effort by the vendor and organization at understanding the capabilities and limitations of an updated or newly installed process, equipment or solution. The Food & Drug Administration 21 CFR 820 Quality System Regulation will be used as the guideline at developing the validation and testing protocols. The organization can use the successful completion of the validation as contingency to final acceptance of the equipment or solution.
- Conduct Equipment Integration & Validation training
- Define the need and requirement of the purchase
- List the equipment or solution features and benefits
- Identify the equipment performance capability and capacity
- Develop the validation protocols
- Conduct validation activities
- Identify and implement corrective action, if necessary