GAMP

SIGamp – Shareware

Transform Your Automation Experience with GAMP by SIGamp

Pete Milner

01/21/2025

GAMP by SIGamp is a robust software application that streamlines automation processes and regulatory compliance for industries, facilitating efficiency and accuracy in operations.

GAMP (Good Automated Manufacturing Practice) is a set of guidelines created by the Special Interest Group on Automation of the International Society for Pharmaceutical Engineering (SIGamp). The purpose of GAMP is to provide a framework for the development and validation of automated systems in pharmaceutical and medical device manufacturing.

GAMP provides a risk-based approach to system validation, which helps manufacturers ensure that their automated systems are reliable and meet regulatory requirements.
The guidelines cover all stages of the system lifecycle, from planning and development to operation and maintenance.
The principles outlined in GAMP can be applied to a variety of automated systems, including manufacturing and laboratory equipment, process control systems, and software applications.

By following GAMP guidelines, manufacturers can improve the quality, safety, and effectiveness of their products, as well as reduce the risk of non-compliance with regulatory bodies.

Overview

GAMP is a Shareware software in the category Miscellaneous developed by SIGamp.

The latest version of GAMP is currently unknown. It was initially added to our database on 11/08/2007.

GAMP runs on the following operating systems: Windows.

GAMP has not been rated by our users yet.

Pros

Comprehensive platform for managing GxP (Good Practice) processes in the life science industry
Helps organizations achieve compliance with regulations such as FDA, EMA, and other global standards
Offers modules for quality management, risk management, supplier management, and document control
Provides tools for tracking and documenting processes for audits and inspections
Supports electronic signatures and workflows for efficient approval processes

Cons

Can be complex to set up and configure due to the various modules and functionalities
May require training for users to fully understand and utilize all features
Cost of the software and implementation may be high for smaller organizations
Updates and maintenance may require additional resources and investment

FAQ

What is GAMP?

GAMP stands for Good Automated Manufacturing Practice and it is a set of guidelines developed by the International Society for Pharmaceutical Engineering (ISPE) to ensure the effective use of automated systems in pharmaceutical manufacturing.

Who developed GAMP?

GAMP was developed by the Special Interest Group for Automation of the ISPE (SIGamp), which is a global organization of pharmaceutical professionals dedicated to promoting best practices in automated manufacturing systems.

What is the purpose of GAMP?

The purpose of GAMP is to provide industry-accepted guidance for the validation and compliance of automated systems, ensuring they are fit for their intended use and meet regulatory requirements.

What does GAMP cover?

GAMP covers various aspects of automated systems, including validation methodologies, risk management, quality management, data integrity, software development lifecycles, and supplier management.

Who should follow GAMP guidelines?

Pharmaceutical manufacturers, equipment suppliers, system integrators, and anyone involved in the development, implementation, or maintenance of automated systems in the industry should follow GAMP guidelines.

How frequently are GAMP guidelines updated?

GAMP guidelines are periodically updated by SIGamp to keep pace with evolving industry practices, technology advancements, and regulatory requirements.

What is GAMP 5?

GAMP 5 is the latest version of the GAMP guide published by ISPE. It provides a risk-based approach to validation and emphasizes the integration of automated systems with quality management systems.

Are GAMP guidelines regulatory requirements?

GAMP guidelines are not regulations themselves, but they provide industry best practices that align with regulatory expectations. Following GAMP helps organizations comply with regulations such as FDA's 21 CFR Part 11 and EU's Annex 11.

Does GAMP apply only to pharmaceutical industry?

While GAMP was initially developed for the pharmaceutical industry, its principles and guidelines are also applicable to other regulated industries that use automated systems, such as biotechnology, medical devices, and food manufacturing.

Where can I access GAMP guidelines?

GAMP guidelines can be accessed through the ISPE website or by becoming a member of SIGamp, which provides access to exclusive resources, training, and networking opportunities.

Pete Milner

I'm Pete, a software reviewer at UpdateStar with a passion for the ever-evolving world of technology. My background in engineering gives me a unique insight into the intricacies of software, allowing me to provide in-depth, knowledgeable reviews and analyses. Whether it's the newest software releases, tech innovations, or the latest trends, I'm here to break it all down for you. I work from UpdateStar’s Berlin main office.

Latest Reviews by Pete Milner

Download not yet available. Please add one.

Stay up-to-date
with UpdateStar freeware.

Latest Reviews

	HWMonitor Monitor your hardware with ease!
	TweakPower Boost Your PC Performance with TweakPower!
	Kalorické Tabulky Effortlessly Track Your Nutrition with Kalorické Tabulky
	SRWare Iron Enhanced Privacy and Security with SRWare Iron Browser
	GOM Player GOM Player: Your Ultimate Media Player
	Hyper File Manager Streamline Your File Management with Hyper File Manager

Most Popular Downloads

	UpdateStar Premium Edition Keeping Your Software Updated Has Never Been Easier with UpdateStar Premium Edition!
	Microsoft Visual C++ 2015 Redistributable Package Boost your system performance with Microsoft Visual C++ 2015 Redistributable Package!
	Microsoft Edge A New Standard in Web Browsing
	Google Chrome Fast and Versatile Web Browser
	Microsoft Visual C++ 2010 Redistributable Essential Component for Running Visual C++ Applications
	Microsoft Update Health Tools Microsoft Update Health Tools: Ensure Your System is Always Up-to-Date!