ACG GROUP: ‘World’s only market-ready track & TR solutions provider’ for EUFMD – Inspections business launches groundbreaking Track & Trace capabilities.
ACG is the ‘world’s only market ready Track & Trace solutions provider’, in accordance with the EU Falsified Medicines Directive (EUFMD) – which comes into effect in February 2019…
This directive has made it vital for pharmaceutical organisations to find a market-ready implementation partner.
ACG, the leading global supplier of integrated manufacturing solutions for pharmaceutical and nutraceutical companies, has developed modular customisable solutions from line to repository levels through its Inspection business. Each meeting the verification, data management, serialisation, tamper evident and government reporting requirements issued by EUFMD.
ACG Inspection’s Verishield offers Level 1 to Level 5 solutions that includes:
Level 5: Government Repository
Supporting country-specific data reporting functionality to the government portals like EMVS reporting for Europe, DAVA reporting for India, Government reporting for Turkey, etc.
Level 4: Cloud Solution
Hosting centralised server on cloud platform for multiple Marketing Authorisation Holder (MAH) plants and CMO management, data management, master data management for worldwide regulations.
Level 3: Plant solution, CMO solution and advanced warehousing Incorporating data management, data backup, line registration, LDAP Configuration, basic warehouse functionality, Line management, centralised printing templates.
Level 2: Line Level Serialisation and Aggregation Machines Line level machines with product wise number management, support for worldwide regulations templates, basic workflow supporting production orders. We also provide support for aggregation of products for multiple packaging levels for all regulations.
Level 1: Unit Level Controller
The system is equipped with actual devices for sensing and manipulating the physical processes.
Supports a range of printers, cameras and scanner
Ettore Cucchetti, the CEO of ACG Inspection, said: “ACG Inspection are global track & trace experts, offering end-to-end solutions. Our implementation experience spans the entire globe with pharma serialisation solutions delivered for over 800+ lines across the world. We have worked hard to meet the EUFMD requirements and are delighted to be 5-steps ahead, having developed a market-ready solution.”
ACG Inspection Affiliations:
ACG Inspection is proud to be listed as an On-boarding Partner (OBP) by the European Medicines Verification Organisation (EMVO)- the guarantee of patient safety in Europe. An OBP is a legal entity that is part of a Corporation or a Group that will send data to the EMVO on behalf of Marketing Authorisation Holders that are also part of that corporation.
ACG Inspection is also a member of Open Serialisation Communication Standard group (Open SCS) which is a dedicated group of vendors and pharmaceutical manufacturers that have come together to standardise the packaging line serialisation and aggregation data exchanges.