What Is The Difference Between 21CFR And GAMP

29th September, 2025.

In this post, we will see the difference between 21CFR and GAMP.

When you are working in strict and stringent sectors related to automation like pharmaceuticals or food and beverages, you need to work in a very tight and precise manner of control systems, for adhering to their standards. Regulatory authorities frequently perform audits, and if any lag is found, then it largely affects the business, as the product sale and quality is questioned for use. For these, two such guidelines are present in the market for complying to these standards, which are 21CFR and GAMP. In this post, we will see the difference between 21CFR and GAMP.

What is US FDA 21CFR Part 11?

First of all, let us understand what US FDA 21CFR Part 11 is. FDA is nothing but the Food and Drug Administration, a US body. It is a set of rules and regulations which majorly deals in audit trails and electronic signatures. Audit trail is a function which is done to record who did a change in the system and when, with exact date and time stamp. This record cannot be tampered with. 21CFR also includes user management, where user policies like role assignment or user matrix, password expiry, password changing, user locking, change in role assignment in runtime by an administrator, allowing access to files to only assigned user roles, and password set policies, are given to the operators and system handlers. Due to this, strict user operation is maintained. Electronic signatures are a step to enter user ID and password, when any setpoint is changed. This ensures that the operator has himself e-signed the change, which has now been recorded in the database. Also, the record in audit trail should log both the new and previous values. 

All the records must be maintained in a database for a prolonged period of time without any alteration, so that whenever any inspection occurs, the data can be checked for quality control. E-signature must be regularly updated with documents with the latest user credentials, with access given only to administrators. This helps to verify the e-signed entries that are logged in the system. In short, 21CFR is a rule which says what is to be followed for the product compliance to be passed and used in the market. 

What is GAMP 5?

GAMP stands for Good Automated Manufacturing Practice. It is a guideline developed by the International Society of Pharmaceutical Engineering (ISPE). While 21 CFR dealt on what are the rules, GAMP implies on how to follow them. So yes, even 21CFR had some rules on how to follow it's compliance by audit trails, user management and e-signatures, but it is limited only to automation programming. And it is the master to follow, meaning 21CFR is the end result of a final and full fledged precise system. But how to do it from the sratch, that is done by GAMP. This is the major difference which the engineers must understand, where 21CFR is the - what are the rules, and GAMP is - how to implement those rules. 

GAMP does this by the following methods in steps:

1. Understand the user requirements or URS, by reading that particular document from the customer. For example, it may state that pressure value must be logged every one minute, with compliance to 21CFR.

2. Create an FS or functional specification, to be shared to the customer, which will have in detail logic of how the system will perform this task with the control logic and flow mentioned properly. It must also adhere to risk assessment factors of the process. It also has system architecture, PLC IO list, and communication network design. 

3. The next step will be to evaluate vendor or system supplier, and checking whether their product will cater to 21CFR compliance and will follow GAMP standard by this.

4. Perform IQ or installation qualification test where all the hardware will be verified, software installed will be verified, network patches, switches and configuration will be verified, all the components match their BOM, SCADA license and version is verified, and calibration certificate is verified. IQ is the base for starting the next steps, which states the devices which will perform in the system are fully verified to operate further. 

5. Perform OQ or operational qualification, where all the control logic will be verified and whether the system is complying to 21CFR or not, by checking alarms, audit trails, trends and data logs. 

6. Perform PQ or performance qualification, where the system output is checked for a couple of days, to verify whether it is performing as per design, and by fully complying with 21CFR.

7. A risk based approach is done to check various failure modes, effect analysis and thus undermining and designing the risk matrix.

In short, GAMP is a risk based approach towards lifecycle management, by computer system validation or CSV. Means, it specifies all the steps that need to be considered to achieve the final 21CFR compliance. If GAMP is not proper, then 21CFR is not proper. The systems also need to be updated as per current regulations, so that the whole system is maintained in the lifecycle till retirement. And the main thing to note is that GAMP has these following categories of software types to validate the functionality we mentioned earlier - infrastructure software, non configuration software, configuration software and custom software. 

GAMP vs. 21CFR:

1. 21CFR is a standard which says what rules to follow, whereas GAMP is a standard which says how to follow those rules.

2. 21CFR is a legally binding regulation, whereas GAMP is a best practice framework to implement those regulations.

3. 21CFR focuses on records and data integrity, whereas GAMP focuses on validation and lifecycle management of automation systems by computer system validation.

I have covered the difference between 21CFR and GAMP. I have also not attempted to cover all the topics related to it, as it can vary from case to case. Once you are familiar with this type of technology, you can easily troubleshoot any issues related to it.

Thank you for reading the post. I hope you liked it and will find a new way in this type of technology.