GAMP
SIGamp – SharewareTransform Your Automation Experience with GAMP by SIGamp
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.
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