The folks behind GAMP5 are perhaps the worst in naming things. And one of the worse is the whole standard versus normal changes. Maybe when naming two types of changes do not use strong synonyms. Seems like good advice in general, when naming categories don’t draw from a list of synonyms.

Computer system changes and the GAMP5 framework

Based on the search results, here are the key differences between a standard change and a normal change in GAMP 5:

Standard Change

1. Pre-approved changes that are considered relatively low risk and performed frequently.
2. Follows a documented process that has been reviewed and approved by Change Management.
3. Does not require approval each time it is implemented.
4. Often tracked as part of the IT Service Request process rather than the GxP Change Control process.
5. Can be automated to increase efficiency.
6. Has well-defined, repeatable steps.

So a standard change is one that is always done the same way, can be proceduralized, and is of low risk. In exchange for doing all that work, you get to do them by a standard process without the evaluation of a GxP change control, because you have already done all the evaluation and the implementation is the same every single time. If you need to perform evaluation or create an action plan, it is not a standard change.

Normal Change

1. Any change that is not a Standard change or Emergency change.
2. Requires full Change Management review for each occurrence.
3. Raised as a GxP Change Control.
4. Approved or rejected by the Change Manager, which usually means Quality review.
5. Often involves non-trivial changes to services, processes, or infrastructure.
6. May require somewhat unique or novel approaches.
7. Undergoes assessment and action planning.

The key distinction is that Standard changes have pre-approved processes and do not require individual approval, while Normal changes go through the full change management process each time. Standard changes are meant for routine, low-risk activities, while Normal changes are for more significant modifications that require careful review and approval.

What About Emergency Changes

An emergency change is a change that must be implemented immediately to address an unexpected situation that requires urgent action to:

1. Ensure continued operations
2. Address a critical issue or crisis

Key characteristics of emergency changes in GAMP 5:

1. They need to be expedited quickly to obtain authorization and approval before implementation.
2. They follow a fast-track process compared to normal changes.
3. A full change control should be filed for evaluation within a few business days after execution.
4. Impacted items are typically withheld from further use pending evaluation of the emergency change.
5. They represent a situation where there is an acceptable level of risk expected due to the urgent nature.
6. Specific approvals and authorizations are still required, but through an accelerated process.
7. Emergency changes may not be as thoroughly tested as normal changes due to time constraints.
8. A remediation or back-out process should be included in case issues arise from the rapid implementation.
9. The goal is to address the critical situation while minimizing impact to live services.

The key difference from standard or normal changes is that emergency changes follow an expedited process to deal with urgent, unforeseen issues that require immediate action, while still maintaining some level of control and documentation. However, they should still be evaluated and fully documented after implementation.