Good Automated Manufacturing Practices, also known as GAMP was developed to address regulatory and FDA requirements for computerized systems. This is especially important in industries that must adhere to HIPAA regulations, such as the medical and pharmaceutical manufacturing industries.
By abiding by top GAMP 5 best practices, formal processes and tests are performed to gain access to information. All systems must pass a required number of validation requirements.
Companies that adhere to these policies, including User Requirements Specifications, should create a safe environment. Free from the compromising of information or issues with testing and auditing.
Here are GAMP 5’s key principles:
– Companies must ensure that all computer users have a keen understanding of the products and processes.
Management over the lifecycle of the management system must be supported.
– The lifecycle should be able to ramp up and down based on scalability.
– Risk management should be science-based.
– Suppliers should be able to use the process as a scienced-based risk management tool.
Those that abide by the requirements of GAMP will be compliant with all internal processes and requirements.