Pharmaceutical labeling

In the tightly regulated market for prescription and over-the-counter drugs, the accuracy and completeness of content on labels and packaging is paramount. Pharmaceutical manufacturers must comply with numerous global and regional regulations, which adds levels of complexity to the process of managing labeling and packaging artwork. Errors not only require costly recalls but may also result in fines and damage to the company and brand’s reputation.

Loftware's solutions help pharmaceutical manufacturers improve the accuracy and automated management of labels, packaging artwork and their associated content by:

• Enabling users to quickly build, update and share labels, templates, patient leaflets and other documents that comply with DSCSA, 21 CFR Part 11 ERES, EU FMD and other regulations
• Eliminating inefficient, error-prone data replication with centralized labeling and packaging artwork management that integrates with sources of record
• Offering resources that save time and reduce the costs of implementing a validated solution
• Supporting control and compliance with regulations and customer requirements, with full version control, audit tracking and traceability reports
• Managing multi-lingual copy requirements with version-controlled phrase/translation management to ensure accurate labeling across the globe
• Leveraging standardized enterprise-wide labeling and GS1 barcode standards to improve traceability and help prevent counterfeiting