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Standardized Protocol for Method Validation/Verification Standard Operating Procedure Quality Assurance Unit Laboratory Services Section Austin Table of Contents I.Purpose.

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ISO/IEC 17025 defines validation as “the confirmation by examination and the provision of objective evidence that the particular requirements for specific intended use are fulfilled”. Validation is specifically intended to be used as an analytical requirement.

The four fundamental methods of verification are Inspection, Demonstration, Test, and Analysis.

Method validation of test procedures is the process by which one establishes that the testing protocol is fit for its intended analytical purpose. This process has been the subject of various regulatory requirements.

The most common techniques used fall into two categories: data validation and data verification.

ISO 16140-2 is the base standard for alternative methods validation and is cross-referenced by the other parts of the 16140 series. It includes two phases, the method comparison study and the interlaboratory study, with separate protocols for the validation of qualitative and quantitative microbiological methods.

A few verification methods are inspection, code review, desk-checking, and walkthroughs. A few widely-used validation methods are black box testing, white box testing, integration testing, and acceptance testing. The quality assurance (QA) team would be engaged in the verification process.

Validation methods Validation MethodDescriptionRange checkChecks the data falls between an acceptable upper and lower value, within a set rangeType checkChecks that the data entered is of an expected type, e.g. text or a numberLength checkChecks the number of characters meets expectations, e.g. an 8 character password2 more rows

A) Prospective validation (or premarket validation) B) Retrospective validation. C) Concurrent validation. D) Revalidation.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232