The Good Automated Manufacturing Practice GAMP is a group of guidelines to perform implementations and validations following the System Development Life Cycle SDLC.. It was created by ISPE to address FDA and other regulatory agency expectations for computerized system compliance and validation. In addition, the GAMP® Good Automated Manufacturing Practice GAMP is recognized globally by regulated companies and their suppliers and are widely supported by regulatory agencies.
For example, the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.
GAMP® guidance aims to achieve computerized systems that are fit for the intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
GAMP Good Practice Guides are a series of documents providing practical guidance on the implementation of different applications in the industry.
This guidance may be applied to both new and existing GxP regulated computerized systems.
The GAMP Good Practice Guides available at the time of publication of this article are:
Good Practice Guide Title Publication: Good Automated Manufacturing Practice GAMP
GAMP Good Practice Guide: Calibration Management 2001
GAMP Good Practice Guide: Validation of Process Control Systems 2003
GAMP Good Practice Guide: The Validation of Legacy Systems 2003
GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures 2005
GAMP Good Practice Guide: Validation of Laboratory Computerized Systems 2005
GAMP Good Practice Guide: IT Infrastructure Control and Compliance 2005
GAMP Good Practice Guide: Global Information Systems Control and Compliance 2005
GAMP Good Practice Guide: Testing of GxP Systems 2005
GAMP Good Practice Guide: Electronic Data Archiving 2007
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For more details on specific FDA expectations and how to perform a Computer System Validation SDLC, follow us.
Three (3) Options to Create a Computer System Validation Protocol following the Good Automated Manufacturing Practice GAMP:
Option 1. You Can Create CSV Protocol, using a Template.
You can download samples of the validation templates in .pdf format.
To see the complete list of the most popular validation templates, click here.
In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.
Option 2. We Can Bring You a Formal Training on the Systems Development Life Cycle.
This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections. It includes the template, an exam, and a training certificate for each assistant. Request a quote now.
Option 3. We Can Create Customized Test Scripts and Computer System Validation Protocol.
One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.
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REFERENCES: Good Automated Manufacturing Practice GAMP and others
Food and Drug Administration References
Industry References: Good Automated Manufacturing Practice GAMP and others