The and also covers process changes and challenges.

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Last updated: April 15, 2019

The Validation process in the Medtech industry is criticalto making both safe and effective medical products.

This industry has seen alot of changes over the years especially in the field of Validations due to anincreased emphasis on applying a risk based approach to validation as well asan increased importance on data integrity and Electronic records.  The main purpose of performing Validations isto establish documented evidence that a process, equipment or method will consistentlyfulfill particular requirements for a specific intended use. (21CFR 820). Thisis completed by following the regulatory requirements, GxP requirements andappropriate qualification tools. The most effective way to apply validationpractices in industry is by using a lifecycle approach to validations.LiteratureReviewRegulatoryand Giodance Review Prior to performing a validation of any nature it isimportant to fully understand the validation requirements from a regulatoryperspective.

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There are three main Regulatory Standards that need to be followedwhen completing validations; 21 CFR 820, ISO 13485:2016 and, if applicable, 21CFR Part 11.TheCode of Federal Regulations Part 820, (Quality System Regulation)CFR Part 820 (Quality System Regulation) outlines qualitysystem and cGMP (Current Good Manufacturing Practices) regulations for medicaldevice manufacturers to ensure that the devices are safe and effective. The FDAQS regulation is applicable to finished medical devices sold commercially inthe USA, including devices that are imported. (1).

its’ intent is to define themanagement of quality systems as it relates to the design manufacture packagingand labeling a medical product. 21CFR 820 Subpart G (820.75) relates to initialvalidation of a process followed by monitoring process performance aftervalidation and also covers process changes and challenges.

  ISO13485:2016In parallel with 21 CFR Part 820 a strong understanding of ISO 13485:2016 is also essential. It isworth noting that ISO 13485:2016 is a voluntary standard for Quality ManagementSystem of medical devices. However, it was recently updated (2016 from 2003) tohelp users meet common regulatory requirements. Aligning with ISO has thebenefit of monitoring medical device safety and overall effectiveness. Thefocal point of ISO 13485:2016 is risk management and risk based decision makingfor most of the QMS process.

(2) Greenlight guru21CFR Part 11Part 11 applies to records inelectronic form that are created, modified, maintained, archived, retrieved, ortransmitted under any records requirements set forth in Agency regulations. (Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application) Part 11 is specific to electronic records (Subpart B)and electronic signatures (Subpart C). 21 CFR Part 11 must be applied tovalidations with respect to audit trails, user access control and controlsaround record retention.

 GAMP5 – A Risk Based Approach to Compliant Computerized SystemGAMP 5  In a nutshell, GAMP®5: A Risk-Based Approach to CompliantGxP Computerized Systems provides a framework for the risk-based approach tocomputer system validation where a system is evaluated and assigned to apredefined category based on its intended use and complexity. Categorizing thesystem helps guide the writing of system documentation (includingspecifications and test scripts and everything in between). 

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