A single solution for regulatory compliance



Andrea Ruosi explains how an integrated solution can help manufacturers manage their regulatory environment in the most effective manner


Pharmaceutical companies are facing an increasingly stringent regulatory environment. New pharma rules such as the drug pricing landscape in the UK has made compliance even more difficult. However, success for manufacturers hinges on their ability to effectively keep up to date with new and existing regulations in a cost- and time effective manner.


Many pharmaceutical manufacturers continue to work with separate best-of-breed systems from different suppliers. Nonintegrated solutions are a nightmare from a regulatory compliance perspective, negatively affecting productivity and quality, and proving costly in terms of risk and resource. Critical information is often duplicated, thus causing mistakes (for example the wrong version of a master batch record) and interfaces are expensive and delicate while being considered high risk points from a validation perspective. In addition, when working with a non-integrated solution, manufacturers have to mitigate the high risk of human error and incorrect information with paper-based procedures and signatures.


Integrated systems are the most effective way to manage the growing complexity in regulatory compliance and negate the risks and cost factors. Integration means better quality and cost reduction, as well as faster time to market.


AX for Pharma is a fully integrated enterprise resource planning (ERP) solution for the pharmaceutical industry, based on Microsoft’s flagship ERP offering Dynamics AX. The solution makes it easier to achieve compliance with quality regulations and specifically FDA validation by providing a full solution for pharmaceutical manufacturers that reduces risks and minimizes the global cost of regulatory compliance.


The AX for Pharma solution provides seamlessly integrated modules and features supporting the following business processes:


  • Quality control and assurance
  • Manufacturing execution and dispensing
  • SOP and CAPA management
  • Plant maintenance
  • Plant maintenance
  • Activity-based product costing
  • Plant maintenance
  • Lot traceability
  • Regulatory compliance including 21 CFR Part 11
  • Advanced record-level security (helpful for compliance to financial regulations)
  • Electronic signature fully compliant with 21 CFR Part 11.

Our product is continuously growing and evolving, just like our customers. New features, enhancements and modules are being developed to provide our customers with a reliable and up-to-date solution that addresses industry and regulatory requirements. AX for Pharma has a network of partners and customers in Europe, the US, South America and Asia that help it in its goal of pursuing global compliance for all pharmaceutical manufacturing.


Andrea Ruosi is CEO of AX for Pharma