© 2021 Andvista Consulting
Pharmaceutical Traceability
GO WITH VISION
What we do to solve the problem
AndVista helps pharmaceutical companies achieve not only regulatory compliance in markets, such as China, Brazil, the U.S. and others, but more importantly to create value beyond compliance. Value creation in pharmaceutical traceability is a novel and even a radical idea because most pharmaceutical companies, in our view, are thinking about how to comply, not how to comply and create value.
Validation: To ensures compliance with pharmaceutical regulations, mitigates risks, and safeguards product quality and patient safety. AndVista proposes IT validation. It is a proactive approach to maintaining operational excellence and meeting stringent regulatory demands.
AndVista traceability approach is based on our unique point of view, which is in part:
  • Traceability has to be part of a broader and more strategic supply chain perspective which considers customers, orders, inventory, systems and trading partners,
  • Most traceability data that a company needs (perhaps as much as 80%) resides beyond its four walls with partner systems,
  • Data orchestration (not just data management) inside and outside the four walls is critical for traceability success,
  • Multiple industries, such as Consumer Packaged goods, Aerospace & Defense, and Food & Beverage face similar traceability challenges.
  • More disparate pharmaceutical traceability market requirements and identification of medicinal products during their entire life cycle (ex:IDMP) will emerge as more countries acknowledge the value of protecting patients and consumers,
When is AndVista expertise in validation needed:
IT validation in the pharmaceutical industry is a critical process to ensure that computer systems comply with regulatory requirements and function consistently, accurately, and reliably. IT validation is needed in the following scenarios:
  • Implementation of new systems,
  • Upgrades or modifications to existing systems,
  • Data integrity concerns,
  • Regulatory compliance requirements,
  • Integration with other systems,
  • System migration or decommissioning,
  • Periodic review or re-validation,
  • Use of cloud-based or third-party systems.