Regulatory compliant labeling solutions

Counterfeiting, mislabeling, and a lack of tracking in the pharmaceutical and medical labeling supply chain have pushed extensive mandates and compliance standards worldwide. According to industry analysts, compliance with various track and trace regulations will cover over 70% of global medicines by 2017.

The serialization, product tracing, product verification and government reporting requirements are complex and the risk high.

Pharmaceutical labeling

Deploy a centralized NiceLabel label lifecycle management solution to:

  • Consolidate and reduce your label templates
  • Streamline label design and approval process
  • Ensure label quality and reduce risk
  • Reduce production setup and downtime
  • Increase agility and faster time to market
  • Simplify the maintenance process

Download the Krka Case Study

Download Pharma Case Study

FDA Pharma Labeling

FDA 21 CFR Part 11 Compliance

Drug and medical device manufacturers and other FDA regulated industries are required to provide electronic records and signatures as the reliable equivalent to paper records. NiceLabel Control Center Enterprise allows organizations to generate labels worldwide, while still keeping central control of label lifecycle management.

  • Deploy review and approval workflows to prevent production errors and product recalls
  • Full label lifecycle management and audit trail
  • Auditable security protocols and access permissions
  • Incorporate electronic signatures for controlled labeling
  • Harness built-in business rules for improved efficiency and accuracy

EU Good Manufacturing Practice (GMP) Annex 11

Annex 11 is the European equivalent to the FDA’s 21 CFR Part 11 compliance mandating the use of electronic records and signatures. NiceLabel Control Center Enterprise allows organizations to generate labels worldwide, while still keeping central control of label lifecycle management.

  • Justify new manufacturing standards and acceptance criteria through label lifecycle management processes
  • Manage access permissions and proactive review and approval process
  • Manage the storage of auditable electronic records
  • Maintain a quality control safety net for inspector audits
GMP Annex 11

Unique Device Identification

Various classifications of medical devices are being pushed into new bar code labeling compliance, Unique Device Identification. Medical device manufacturers now require enterprise label software to indicate the device identifier and production identifier on every medical device label. NiceLabel ensures that manufacturers are compliant with regional requirements on a global scale.

Learn more about FDA UDI labeling

ePedigree Pharmaceutical Track and Trace

Counterfeit drugs, mislabeling and contamination are a growing concern in the pharmaceutical industry. ePedigree laws increasingly mandate track and trace systems able to track the complete lifecycle of a drug in the highly complex pharmaceutical supply chains.

  • Ensure patient safety from contaminated and counterfeit drugs
  • Support unit-level visibility for manufacturers and cut recall costs
  • Increase shipment management efficiency
  • Seamlessly integrate into existing SCM systems