With changes in labelling regulations in the medical and pharmaceutical industries having a labelling solution that can grow and adapt with these changes is critical
With Nicelabel products you can meet the following regulations
FDA 21 CFR Part 11 : Label lifecycle management
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
Using Nicelabel Control Centre 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 GMP Annex 11 : Electronic Record and Signature trail
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
UDI Labelling : Unique Medical 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
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