ELPRO advances software to manage complex supply chain temperature data23.Sep.2016
ELPRO has announced a new release of liberoMANAGER, the globally accessible SaaS tool to send, collect, archive and release pharmaceutical shipments from a central system. The updated software enables manufacturers to comply with ever increasing regulations, especially concerning data integrity.
In the past two years, the MHRA, FDA and WHO have written guidelines for tighter management of data from all GMP and GDP sources. Regulators are expecting all data to be complete, contemporaneous, and connected to all metadata, including who accessed or modified the data. Cold chain data is no exception. The MHRA gave an example of an inspection citation whereby only two data loggers were used in an airfreight shipment with 11 pallets. This is simply not acceptable in proving protection of the product Since this inspection, the MHRA has stated their expectation is minimum one data logger per pallet.
Being able to group pallets in a shipment using software to manage the shipments and associated temperature data, not only aids compliance but gives the QA Manager greater visibility into the complete shipment’s components. . This aggregated status of data from several LIBERO PDF Loggers can now be displayed in liberoMANAGER. The updated liberoMANAGER software offers automation in cold chain decision making by setting up workflows that QA sets in the software, so when it comes time to release a shipment, it can be done automatically if the pre-determined criteria allow it.
Advanced User Management capabilities in the liberoMANAGER update also help pharma comply, whilst building in process efficiencies. Data integrity regulations state that timestamped data must be archived for each activity and user accessing the data. Advanced User Management allows the QA Manager to assign roles and access rights to certain people, at the same time restricting access.
Today pharmaceutical supply chains need to be more agile and flexible for supply and demand of smaller quantity, specialty shipments or multi-step supply chains, several depots and partners. This need for agility applies to cold chain temperature data management too. How can manufacturers document end to end control of their temperature control medicines throughout their lifecycle? Using software like ELPRO’s, total time out of refrigeration can be calculated while managing a stability budget across the product lifecycle. Using elproVIEWER in conjunction with LIBERO PDF Loggers allows for these calculations to be done during the distribution chain to make immediate decisions on how to handle the product. For example, if the total allowable excursion time is nearly used before the load gets to the wholesaler, the shipper can decide to increase temperature control measures.
Beat Rudolf, CEO of ELPRO, describes the recent advances in liberoMANAGER, «Pharmaceutical manufacturers want to easily manage product stability across the supply chain, retain control with a central system, at the same time have the flexibility to assign certain roles and rights». From a QA perspective, avoiding using spreadsheets or paper files, eliminates the possibility of data manipulation because the original LIBERO PDF report and all additional data are stored in a data base and all alterations are recorded in an audit trail.
Highlights of liberoMANAGER 2016.7 include:
• One globally accessible cloud platform (SaaS) with embedded analytics capabilities
• Powerful workflows for handling different processes for different lanes, products and divisions
• Missing Logger Notification to remind recipient to send in LIBERO PDF report or to inform shipper about missing LIBERO PDF reports
• Shipment logic to group several loggers/packages in one shipment
• Flexible import and export from ERP systems
• Advanced User Management, assigning roles and restricting rights to certain users
• No software installations needed
• No database user needed to send or receive data
ELPRO will be teaching a workshop September 27th on «Preparing your Clinical Supply Operations for the Volume of CRT and Specialty Biologics» where liberoMANAGER will be used to show how to perform shipment analytics, correct nuisance alarms, and why a central database makes sense, certainly for larger volume supply chains. The workshop is part of the Cold Chain Global Forum in Boston.