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The FDA defines validation as a process required to establish documented evidence that provides a high degree of confidence that a specific system, equipment, computer system, or method will consistently meet the requirements and its intended use. Validation is a regulatory requirement for the life sciences industry across the world. In addition to enabling life sciences to comply with regulatory requirements, validation offers many advantages to businesses.

Analytical validation is used to verify that the selected analytical procedure will give you reliable, adequate results for their intended purpose. It will ensure repeatability and duplicability within the testing methods to ensure your test results accurately represent the product.

Process validation demonstrates and documents with a high degree of certainty that the process will reliably produce a product within the predetermined quality specifications. This type of validation also assures the repeatability of the process; by undergoing a comprehensive process validation before product distribution, the risk of manufacturing problems decreases, which increases the output and the product quality.

Retrospective validation techniques are very effective and are vital components of a product recall process. It is a process validation of a product already in circulation based on accumulated production testing and control data. Root cause analysis is also a technique of validation. The structure and rigor demanded of the validation process usually help with the recall’s conclusion. Retrospective validation is a method that can be useful in determining a process failure.

Cleaning validation ensures that particular systems, equipment, or parts of the equipment are consistently cleaned to the previously determined acceptable limits. Adequate cleaning procedures play an essential role in preventing contamination leading to adulterated products.

Equipment validation is based on the principle that equipment must be designed, constructed, maintained, and adapted to perform specific operations. Since the equipment is a basic component of the life sciences, it becomes a primary issue to document evidence of equipment validation.

A comprehensive validation plan can have a positive impact on the business and the product itself. EMMA International has helped many clients with validation protocols and procedures as well as other quality management measures. If you need assistance with validation, quality, or regulatory compliance issues, contact EMMA International at 248-987-4497 or email us at info@emmainternational.com.

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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