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Assay Validation

Assay validation is the process used to confirm that an analytical procedure is suitable for its intended use.  

 

Careful consideration needs to be given to the whole process of analysis to ensure data integrity. The methodology must be validated using specific laboratory investigations to demonstrate that the performance characteristics are suitable and reliable for the intended application, and acceptance criteria must be clearly defined. In addition, any equipment or computerised systems used to support the analysis or testing must also be validated to ensure requirements are met, and to ensure both data security and data integrity.

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Analytical methods may need to be re-validated if, for example, they are transferred to another facility, or conditions change outside of the original scope e.g. the analytical procedure changes, the sample matrix changes, or a new instrument with different characteristics is introduced.

Laboratory facilities analysing samples collected from clinical trial participants must comply with laboratory GCP (GCLP) standards. All analytical tests must be properly validated to ensure data integrity.

Facilities preparing tissues and cells for human application must demonstrate that their products are safe, fit for their intended use, and achieve clearly defined quality attributes. This is likely to involve testing at various points during the preparation process, to ensure sterility and quality. Again, the methodology used must be properly validated.

How can we help?

Inefficient or inadequate validation plans and execution can result in substantial delays. ResLabQ&C can help to reduce your validation time and overall investment. We aim to eliminate frustrating repetition during the validation process, and to reduce the impact that will be made by unavoidable minor changes in conditions (e.g. reagent suppliers or grade).  

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We anticipate that our assay validation service will proceed in a series of steps:

Step 1
Project planning

  • Select analytical methodology, controls, standards, reagents, and instruments 

  • Define the application, purpose and scope of the analysis

  • Define the performance parameters and acceptance criteria

  • Define validation experiments

  • Produce Validation Plan

Step 2
Systems validation

  • Laboratory carries out verification of instruments and computerised systems

Step 3
Pre-validation

  • Laboratory carries out pre-validation experiments

  • Review of data generated

  • Adjust method parameters or/and acceptance criteria if necessary

Step 4
Full validation

  • Laboratory completes validation experiments

Step 5
Produce Validation Report

  • Describing the validation procedures, data obtained, evaluations, and comments observed during the validation; comparing the results to what the validation plan defined as a successful outcome 

  • Define criteria for re-validation

ResLabQ&C can support and advise at any, or all, of these steps. We can provide professional templates for the Validation Plan and Report, and help you write these crucial documents.

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Turnaround time is variable depending on the complexity of the validation. On average, it’s 10 to 12 weeks from planning to completion of the Validation Report.

Like what you see? Get in touch to learn more.

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