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Validation Strategies for Mobile Devices and ApplicationsRAUL SOTO, MSC, CQE IT SAN DIEGO 20171 The contents of this presentation represent the opinion of the speaker; and not necessarily that of
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How to fill out validation strategies for
How to fill out validation strategies for
01
Identify the scope of validation strategies, determine which processes or functions require validation.
02
Define the validation objectives and success criteria for each process or function.
03
Gather the necessary data and information needed for validation.
04
Design a validation plan outlining the steps and methods to be used for validation.
05
Execute the validation plan, following the defined steps and methods.
06
Collect and analyze the validation results, comparing them against the defined objectives and success criteria.
07
Document the validation process, including any deviations, findings, and corrective actions taken.
08
Review and evaluate the effectiveness of the validation strategies, identifying areas for improvement and making necessary adjustments.
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Periodically review and update the validation strategies as needed to ensure they remain aligned with changing requirements and best practices.
Who needs validation strategies for?
01
Organizations and businesses that develop, implement, and maintain critical processes or functions.
02
Industries that are highly regulated and require compliance with specific standards or guidelines.
03
Companies that handle sensitive data or provide services that directly impact people's safety, health, or well-being.
04
Any entity that relies on accurate and reliable processes or functions to achieve desired outcomes or deliver high-quality products and services.
05
Individuals or teams responsible for quality assurance and control, risk management, and regulatory compliance.
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What is validation strategies for?
Validation strategies are used to ensure that a product or process meets the necessary requirements and standards.
Who is required to file validation strategies for?
Companies and organizations involved in the development and production of products or processes are required to file validation strategies.
How to fill out validation strategies for?
Validation strategies can be filled out by documenting the steps taken to validate a product or process, including testing procedures and results.
What is the purpose of validation strategies for?
The purpose of validation strategies is to demonstrate that a product or process is reliable, safe, and meets the required specifications.
What information must be reported on validation strategies for?
Validation strategies must include details on the testing procedures, results, and any adjustments made to ensure compliance with standards.
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