Pharmaceuticals, cosmetics, and other FDA-regulated industries need to put in extra effort to ensure that their products remain compliant with the ever-changing rules and regulations. Products from the pharmaceutical and life-sciences industries often use cutting-edge technology in their products and are responsible for consumer health and well-being. Product labeling is indispensable when it comes to consumer safety – they contain information such as dosage, warnings, usage instructions, and more. Brands need to follow a standardized FDA-compliant workflow when it comes to labeling and artwork development for such products. This is where electronic signatures come into play. 

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How does FDA regulate labeling quality?

FDA regulates industries like pharmaceuticals, life sciences, biotech, food, and cosmetics in the U.S. These industries make products that can directly influence public health. Hence, the FDA has a set of rules and regulations to ensure that the product development is transparent and traceable. 

Understanding the 21 CFR Part 11

Over the last few years, label development workflows have changed drastically. Companies now collaborate remotely with designers, printers, and vendors. As brands started using more digital workflows, the FDA introduced a new set of regulations in 2003, titled the 21 CFR Part 11 that regulates electronic documents and signatures. Later, in 2007, the document went through further changes.

Who is the 21 CFR Part 11 for?

The 21 CFR Part 11 applies to every industry which has a direct impact on public health. Industries include food and beverage, cosmetics, pharmaceuticals, life sciences, and medical device manufacturers. These industries need to use software platforms that support sharing data with FDA for quality control purposes. FDA uses this data to verify the purity, strength, safety, and efficacy of the product being sold. The data finally enables FDA to make the ultimate decisions regarding product quality and safety. 

What are electronic signatures and records?

According to the 21 CFR Part 11, electronic signatures and records are defined as follows:

• Electronic Records: It is a combination of text, graphics, or sound which is digitally created, stored, modified, and retrieved by a computer system. In layman's terms, any digital file is a digital record. For example, the label design file, the document with the list of ingredients, or any other digital asset that goes on the label is classified as an electronic record. 
• Electronic Signature: An electronic signature is a set of symbols that an individual can authorize to be legally equivalent to their handwritten signature. For example, an electronic signature can be a digitally recorded signature using a stylus on a touchscreen surface, or a scanned photograph. 

Any FDA-regulated company who opts to maintain and submit data to FDA must abide by the rules set in the 21 CFR Part 11 document.

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How can a label management platform help with e-signatures?

Artwork and Label design software come with industry-standard e-signature solutions. Artwork and labels of medication and related products are under tight regulations. Therefore, to approve the labeling, an authority figure needs to provide an electronic signature, in multiple cases. Here is how a label management platform help in the production workflow.

Signatures from QA or QC

The Quality Assurance or the Quality Control office needs to ensure that the product packaging quality is up to the mark. They should also check that the information on the labeling is correct and free from typos. They should also check that the fonts and colors are consistent before they can approve it.

Signatures from legal team

The legal team checks the label for regulatory issues. They also verify the marketing claims of the label before they can approve it for production.

Signatures during the packaging process

The packaging department needs to verify that the label development process has been approved successfully in the earlier stages. Depending on the industry, the packaging department also must provide e-signatures before the packaging process hits production.

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Advantages of using a label management software with an e-signature solution

#1. Speed up go-to-market

With electronic signatures, you can save a lot of time when requesting signatures. You can streamline the document flow by getting signatures from off-site managers. If an individual forgets to sign, then another senior employee can instantly provide a signature. The subsequent processes will not have to wait for the paperwork to get transferred over to another person who can approve the documents. You can use any internet-enabled device to collect signatures.

#2. Integrates with existing workflows

Label management software, such as ArtworkFlow, can easily augment your existing workflows without much effort. There is no need for any extra third-party tools when capturing signatures. Project managers can set up workflows where they can add checklists and deadlines for reviewers and request them for signatures.

#3. Secures sensitive information

While ink signatures are vulnerable to forgery, electronic signatures can only be made after signing into a secure password-protected portal. Label management tools come with layers of security that make the signing process both secure and easy.

#4. Scales up with your projects

Depending on the label development project, you can request one or ten or fifty people for their signatures. Label management platforms are extremely scalable. You can onboard internal and external collaborators easily. Requesting signatures from them is equally effortless.

#5. Meets industry standards

Label management platforms meet the regulations of the 21 CFR Part 11, making them a secure and compliant electronic signature solution. This standardization allows both brands and external regulatory agencies to have clear audit trails. It makes the workflows transparent, traceable, and free from errors. 

Wrap Up

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