Pharmaceutical labeling management software
Kallik provides pharmaceutical manufacturers with a competitive advantage through offering an end-to-end labeling and artwork management solution which drives compliance with increasing pharmacovigilance and regulatory requirements.
Designed for pharmaceuticals
Our pharmaceutical artwork and labeling management software is designed specifically for regulated industries, giving you confidence in maximizing compliance with your specific industry regulations.
With full real-time audit logs, digital approval processes, and advanced labeling automation, our software enables robust traceability across manufacturer, provider, patient and regulator domains, releasing them from the constraints imposed by legacy and homegrown labeling solutions.
Ensure labeling compliance
Digitize all of your labeling assets in one cloud-based system, with full audit logs and inbuilt approval processes. With Kallik Veraciti, you can have a single source of truth for all of your product labeling assets, giving you full visibility and the ability to change assets across thousands of labels in seconds.
With fully customizable role-based digital approval flows and full audit logs, you can ensure total regulatory confidence in your pharmaceutical product labeling.
Kallik named Top Pharmaceutical Compliance Solutions Provider 2023
Kallik is proud to be recognised as the leading supplier of pharmaceutical compliance solutions by Pharma Tech Outlook. Read more about our win and how we help pharmaceutical companies stay compliant with product labeling.
Ensure Compliance
Ensure comprehensive FDA and EU-compliant labeling to minimize the risk of counterfeit medicines entering the supply chain
Standardize Global Operations
Implement flexible, standardized labeling strategies that de-risk entry into promising emerging markets
Go to Market Faster
Digitize and streamline your labeling process, allowing you to make changes and approve labels faster and go to market sooner
A Single Unified Source of Truth
Align product and package labeling with RIM, MDM, ERP and PLM systems to provide a single source of truth
Enhanced Traceability
Full traceability and transparency over the life sciences supply chain with detailed audit trails of all actions
Automate and Digitize
Minimize the risk of human errors, ensure compliance and improve efficiency with automated artwork and rules-based decisions
Pharmaceutical labeling software for manufacturers
Kallik has a wealth of experience working with life sciences organizations and manufacturers. Our label and artwork management solution, Veraciti™ is continuously adapting to the changing requirements of the pharmaceutical industry. Get in touch today and see how Kallik can benefit your labeling and artwork management process.
Ensuring your pharmaceutical labeling compliance
Pharmaceutical organizations operate within a highly regulated environment and are constantly facing changing regulatory requirements. Learn more about how Kallik can help pharmaceutical companies stay compliant with ongoing and future regulations.
EU Falsified Medicines Directive
These regulations are designed to increase traceability of devices placed on the market. Additional content needs to be included on device packaging and labeling including a Unique Device Identifier (UDI) in the form of a 2D matrix to be scanned at various points across the supply chain, and an anti-tamper device.
Kallik makes it easier to stay compliant with current and future regulations which impact pharmaceutical packaging and labeling.
US FDA Drug Supply Chain Security Act
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.
Identification of Medicinal Products (IDMP)
IDMP is a suite of five standards developed within the International Organization for Standardization (ISO). These standards provide an internationally accepted framework to uniquely identify and describe medicinal products with consistent documentation (including labeling), coding and exchange of product information between global regulators, manufacturers, suppliers and distributors.
Because Veraciti™ stores, indexes and versions every piece of labeling content ever created and maintains a record of which labels use which content, the risk of downstream labeling becoming out of alignment with submission data is greatly reduced.
FDA 21 CFR Part 11 & EU GMP Annex 11 Compliance
More organizations are moving away from traditional ink and paper-based signatures towards managing this process digitally. There are huge benefits to doing so, but for manufacturers regulated by authorities such as the US Food and Drug Administration and the European Commission, it is critical that all labeling and artwork management activities signatures are compliant with both FDA 21CFR Part 11 and EU GMP Annex 11 regulations.
Every approval completed using an electronic signature must be done so in a system that meets the strict technical requirements of these regulations which Kallik meets.
GxP Compliance
We understand that protecting patient and consumer safety is considered in everything our customers do. GxP is a general abbreviation for the "good practice" quality guidelines to ensure products manufactured and distributed by regulated industries are safe and meet their intended use. GxP requires manufacturers of medical devices, pharmaceuticals, cosmetics and certain chemical-related products to implement and demonstrate adherence to appropriate knowledge, practice and processes that underpin a quality-driven, risk-based approach.
Kallik helps heavily regulated industries implement and maintain robust quality systems and processes for labeling to stay compliant with GxP regulations and Good Manufacturing Practice (GMP) principles and guidelines.
Work with a supplier that puts compliance first
Customers in the life sciences industry put their trust in Kallik every day to deliver a compliant software solution from day one and ensure that compliance is maintained each step of the way.
Veraciti is built from the ground up with compliance in mind, and our 20+ years of experience in working with highly regulated industries means that we understand the complaince challenges you face.
How Kallik Works
Enterprise labeling and artwork management software
Book a demo with our expert labeling and artwork team to see the software in action and how your organization can go to market faster, ensure total regulatory compliance, and gain total visibility across your product labels and artworks.
