If you maintain records or submit information to the Food and Drug Administration (FDA) electronically, you need to comply with 21 CFR Part 11.

If you are not aware of FDA’s regulation, this article will tell you all you need to know about it, why it’s important for you and the best way to implement it in your organization.

We’ll also tell you briefly about how our 21 CFR Part 11 compliant solution stack makes it super easy for you to not only adhere to the FDA regulations but also benefit greatly from it.

What is 21 CFR Part 11?

In August 1997, FDA issued a set of regulations that enlist its acceptance criteria for all forms of electronic data.

This set of regulations was issued as Part 11 of Title 21 of FDA’s Code of Federal Regulations, simply known as 21 CFR Part 11. It applies to all electronic records that are created, modified, maintained, archived, retrieved, or transmitted. It also gives us guidelines for setting up an FDA compliant, digital Quality Management System, where digital records and signatures are used in place of traditional methods.

The recommendations under 21 CFR Part 11 are in line with Pharmaceutical Good Manufacturing Practice (GMP).

Why does 21 CFR Part 11 matter?

21 CFR Part 11 was introduced to encourage widest possible use of electronic technology and reap the benefits of increased digitization.

While increased innovation made processes simpler, it also needed to establish tamper-proof processes for authentication ad control.

Implementing 21 CFR Part 11

While the guidelines are quite self-explanatory, they might seem overwhelming for someone en route to ‘going digital’.

With our 21 CFR Part 11 compliant solution stack, you don’t need to pore over lines upon lines of regulations. You can integrate them into your existing system with little to no effort and let our solutions handle the rest.

Not only are our solutions compliant with FDA regulations for electronic reports and signatures but also add a ton of value when it comes to digitization and upgrading your systems and processes.

Without further ado, let’s dive into what benefits our solution stack brings to you:

1. Maintain Audit Trail

Part 11 requires companies to maintain computer-generated, time-stamped audit trails to ensure the trustworthiness and reliability of records.

Recording the detail of every change and sign off event by author, date and time gives you complete traceability and accountability over the decision-making process.

Our solution eLOGS captures all types of data at points of mandatory requirements, transactions, and observations electronically, while maintaining a digital audit trail that allows quick access on demand.

Further, it also eliminates the chances of incorrect entries with real-time alerts enabling you to comply with 21 CFR Part 11.

2. Ensure Data Integrity

FDA requires you to ‘ensure accuracy, authenticity, integrity of your electronic records’.

All our solutions enable you to do that. For example, Manufacturing Operations & Traceability System not only ensures error-free and guided execution of the entire production process but also has an electronic batch recording feature as per 21 CFR part 11.

The previously mentioned solution, eLOGS also allows you to limit access to authorized individuals only as per the regulations.

3. Validate Your System

21 CFR part 11 requires you to ‘validate your systems and processes to ensure accuracy, reliability, and consistent intended performance’.

While all our solutions enable you to validate your records, an example would be Manufacturing Operations & Traceability System, which enables you to ensure complete adherence to processes and assures complete sequence control, helping you to validate your Quality Management System (QMS), which is another Part 11 requirement. This ensures that your products are not deviating from the desired quality standard.

Protection of records to enable their accurate and ready retrieval throughout the records retention period.

4. Carry Out System Checks

Part 11 requires you to carry out ‘operational system checks to enforce permitted sequencing of steps and events, as appropriate.’

Setting up automated workflows for the collection of approvals and signatures give you more control over people and processes in the development cycle.

An example for this would be our solution PHARMISION WOMS, which takes a unique data-driven approach to capture raw material and inventory data at every event, ensures sequence control in workflow and keeps stakeholders informed of operating efficiency of the entire warehouse in real-time.

5. Retrieve Data Easily

Part 11 requires you ‘to enable their accurate and ready retrieval of data throughout the records retention period.’

Let’s take our solution WMS (mobivue) for instance. It allows you to not only drive warehouse operations with maximum efficiency and adhere to FEFO but also makes sure you have 100% traceability compliance, accurate data in real-time, intelligent reports and critical alerts.

This means the records you need are always available to you easily, allowing you to access them easily whenever you need them.


The right solutions can not only make your adherence to 21 CFR part 11 easy but also help you simplify and optimize your processes and systems.

Our solution stack is easy to integrate with ERPs enabling two-way auto data exchange, GMP compliant and collects and stores data strictly following ALCOA+ principles. Implementing our solutions will bring new levels of efficiency to your entire development process, reduce risks, costs, and time, and enable you to completely digitize your existing systems with little to no downtime.

If you are interested in our 21 CFR part 11 compliant solutions, read more at https://www.pharmision.barcodeindia.com/21cfr-part-11-compliance-warehouse-solutions.

Feel free to reach out to us and we’ll be more than happy to clear any doubts you may have.
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