How to comply with regulatory expectations to access compliance data for the entire pharmaceutical supply chain

Published: 20-Sep-2021

The pharmaceutical supply chain must work and must be known, is not a novel idea. Anyone involved in this industry’s quality processes knows that mastering 100% of its supply chain has been unachievable in the current state-of-the-art… until now!

A new way to eliminate this problem

Catena digitises compliance data over the entire pharmaceutical supply chain of any drug released on the market. This innovation alleviates below listed cumbersome processes, which in fact, limit authorities and/or auditors to access the requested data:

  • Mapping of the entire Supply Chain for
  • o each Finished Dosage Form released on the market
    o each purchased item
  • New Supplier/Supplied Item approval: efficient collection, review and approval of data
  • Product Life Cycle ongoing automated updating of compliance data
  • Change Management and related Risk Assessment accuracy

Catena potentiates such processes and scales their execution over the entire supply chain.

Because these information flows can now be digitised, it provides numerous benefits to any company that is willing to gain in transparency, in reliability and in data integrity by mastering the compliance of its supply chain:

  • Whatever the existing inherited IT-systems in place, the data becomes available to any concerned person.
  • Whatever the supply chain structure, its mapping is easy and dynamic.
  • Whatever the supplier category and tier, information is collected and updated through automation.
  • Whatever the number of inspections to undergo, supplier compliance is easily demonstrated, always at hand, and easy to share.
  • Whatever the number of suppliers or finished products, compliance data is now managed for the entire supply chain.

For the first time ever, Qualified Persons and Supplier Quality Assurance access real data and gain in proactivity, while gaining (very) precious time to play in favour of their competitive advantage.

Who should digitise supplier compliance data

Primarily serving Market Authorization Holders’ responsibility, Catena serves particularly well the interests of C(D)MOs. In fact, using such a tool enables to absorb more projects, while drastically improving supply chain knowledge and related communication with Customers.

More broadly, any company involved in the pharmaceutical supply chain, willing to master supplier data and demonstrate accurate information to Authorities, Customers and Suppliers may find this software useful.

It seems evident that digitising the supply chain compliance data is a win-win-win undertaking for the industry, the regulatory bodies and the patients. One might argue that the future will distinguish between companies who are serious about digitising the supplier compliance data as factor of its competitive advantage, and the companies who will remain “as is”.

For years, Rephine Sourcing Ltd has been investigating this topic among various players of the industry ; Rephine has built Catena as a result from the gathered expertise.

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