Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
|Articles|September 2, 2015
- Pharmaceutical Technology-09-02-2015
- Volume 39
- Issue 9
Serialization Software Helps Companies Stay Compliant
Adents’ Pharma Suite serialization software features track-and-trace capabilities.
Adents’ Pharma Suite serialization software, developed in compliance with GMP and 21 Code of Federal Regulations (CFR) Part 11 regulations and following GAMP5 guidelines, features track-and-trace capabilities,
including generation of unique barcodes and importation of serial numbers, affiliations management for origin identification (bundle, pallet, etc.), and distribution of various types of serialized code.
The software is compatible with both information systems (e.g., enterprise resource planning, manufacturing execution systems) and existing production and packaging equipment. Pharma Suite is designed to address both current and emerging regulations.
The software includes the Adents Pharma Exchange gateway to transit serialization data, the Adents Pharma Supervisor to manage and distribute serialized codes, and the Adents Pilot to direct printing and vision systems and manage communication with line equipment.
Adents
Articles in this issue
about 11 years ago
Generating Savings from Room Declassificationabout 11 years ago
Cleaning a Vial Filling Lineabout 11 years ago
Establishing Limits for Dermal Absorption of Elemental Impuritiesabout 11 years ago
A Matter of Tasteabout 11 years ago
CMOs Concerned With Cost of Single-Use Equipmentabout 11 years ago
Manufacturers Face Key Policy and Regulatory Challengesabout 11 years ago
Getting Flexible with Manufacturingabout 11 years ago
Computerized Systems Validationabout 11 years ago
Collaborating on GMP Inspectionsabout 11 years ago
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