The DSCSA mandates full supply chain traceability for prescription drugs dispensed in the US. Serialization data contained on product labeling and packaging must be both machine and human readable and include its National Drug Code (NDC) and Standardized Numerical Identification (SNI) being the serial number plus lot number and expiry date. A 2D data matrix is required on all packages whilst cases can carry either a linear or 2D barcode. Kallik minimizes the impact of staying compliant with current and forthcoming pharmaceutical regulations.
How does Kallik help with the DSCSA?
Kallik helps medical device manufacturers ensure their products are correctly labeled in accordance with both the FDA’s DSCSA and global serialization requirements for device identification, manufacturer, safety and re-use requirements.
• One global platform that manages product and production data, enhancing transparency and traceability
• Maintains consistency and compliance by using a single source of labeling ‘truth’ for all market-facing products
• Improves surveillance of label and content formats to guarantee consistent communication across the diverse product portfolios and differing distribution channels
Check out our latest resources
An Intelligent Approach to Labeling & Artwork

Using an intelligent rules engine helps organizations handle market challenges more efficiently
Do Your Customers Trust Your Label And Your Brand?

The steps organizations should take to ensure their labeling instils trust in their end consumers
Enterprise Labeling Management In Heavily-Regulated Industries: 5 Critical Success Factors

Five success factors for achieving the desired benefits of an end-to-end labeling management project
Establishing End-To-End Control Of Product Labeling

Five important drivers for building a global labeling strategy
Maintaining Labeling Compliance In Highly Regulated Industries

The three areas businesses need to get right to ensure their labeling meets GxP requirements
Fighting COVID-19 with Automated Labeling

How businesses can navigate the uncertainty of COVID-19 with remote, automated labeling capabilities
3 Ways Improving Your Labeling & Artwork Management Process Drives Speed To Market

In a rapidly changing regulatory world, how do you achieve speed to market?
2020 Statistics: The Benefits Of Automated Artwork & Labeling Have Never Been Clearer

Check out Kallik's highly impressive Veraciti™ user data from 2020
Change Management in Uncertainty

Listen to what your teams are telling you, and importantly, check-in with how they are feeling
Remote Software Implementation: Lessons from the COVID-19 Pandemic

Going forward we’ll be introducing new tools that enable collaboration as though we were co-located
Trust in the Cloud: The Value of AWS in Highly Regulated Industries

The value of using the cloud is clear: unrivalled security, and compliance are built in as standard
Why You Should Focus On System Design For Successful Software Implementation

We want our customers to realise the business benefits of using our solution as quickly as possible
Why Can’t Labeling Be as Easy to Manage as Paying My Power Bill?

The best starting point: being willing to view and do things differently
The Transformative Power of Modular Content Generation

In pharma, labeling is critical to continued marketing authorization, confidence, and patient safety
5 Ways to Make Your Supply Chain More Efficient

It is increasingly important your organization remains compliant when it comes to labeling
The Benefits of Applying Business Rules To Labeling In Highly Regulated Industries

The automation of manual tasks frees up resources, allowing you to attend to higher value activities
Simplifying Your Labeling Supply Chain

The steps that can be taken to simplify your labeling supply chain and the benefits this can deliver
Revitalize Highly Regulated Industries With Cloud-Based Labeling And Artwork Management

A lot of locked-in data needs to be released if we’re going to empower the new workforce
Digital Labeling – A Business Rules Approach

Label digitalization enables robust regulatory submissions, increasing approval process transparency
Overcoming Aversion To Change When Adopting New Technologies

New systems can prove vital to the transformation to a more productive working environment
Why Digital Labeling Is Crucial To Successful Digital Transformation

How to ‘digitally enable’ labeling and artwork processes
How To Achieve Supply Chain Compliance

Discussing the need for transparency and visibility throughout the labeling process
Achieving Consistency Through Labeling Digitalization

Label digitalization builds an integrated, transparent supply chain for all involved in the process
How Automated Labeling Can Help Your Organization Meet Strategic Goals

Some of the best streamlined approaches organizations can implement for long-term business benefits
Document Versus Data: Why The Difference Matters

The difference between a document-oriented vs data-oriented way of managing your product information
Is Your Organization Worried About Product And Package Labeling?

Labeling and artwork management requires both transparency and visibility
Integration Can Be Challenging, But We Need To Do It

If you don’t do integration right, you can't maximize the investment you made in enterprise software
Using Compliance Strategically To Enhance Business Processes

Compliance: why it matters and how you can see it as not just a necessity but a mother of invention
How To Optimize Your Factory Printing Process

Manual processes leave factory printing vulnerable to countless errors, so how can this be avoided?
Kallik At 20: Two Decades Of Innovation That Have Shaped Global Label & Artwork Management

What we've learned in 20 years of labeling & artwork management
Keep The Supply Chain Flowing With Truly End To End Integrated Digitization

How Kallik helped manufacturers overcome extensive operational challenges faced by businesses
The Advent of Better Software Application UX to Manage Critical Manufacturing Processes

UX optimised label and artwork management (LAM) software is the next step to optimising manufacturing proce
The Four Trends Set To Disrupt Highly Regulated Industries In 2023

The four trends set to disrupt highly regulated industries in 2023
The Power of Enterprise Labeling Software

Enhancing Compliance and Efficiency in Enterprise Labeling