I need to facilitate operational and regulatory compliance without compromising quality and safety.
In an age of ever-increasing regulatory oversight, Life Sciences
companies around the globe face a heavy burden in their efforts to
achieve compliance with a growing number of regulatory mandates and
reforms. These compliance requirements can present challenges
because of their associated costs and complexities, which can be
significant. However, the cost of non-compliance can be far higher.
These organizations need to be able to depend upon their financial
management solution to facilitate adherence to and documentation of
regulatory compliance.
An enterprise resource planning (ERP) solution that enables your
business to respond to external requirements or changing business
conditions—and that helps you prove that these requirements have
been met—is a critical ingredient for business success in a changing
economic climate. Equally important, is a solution that can automate
the flow of data throughout the systems while providing a security
framework for achieving regulatory compliance.
MAXLife for Microsoft Dynamics AX enables Life Sciences companies
to integrate systems and implement financial best practices that are
the foundation for regulatory compliance initiatives. With MAXLife,
these companies can store, categorize, and search compliance
documents, track document modifications, and ensure that managers
have the necessary alerts, information, and routing materials to
maintain compliance. Microsoft Dynamics can help Life Sciences
companies streamline and achieve compliance with a broad range of
regulatory requirements, such as:
- 21 CFR Part 11
- 21 CFR Part 820
- Adverse Event Reporting
- cGMP
- Document Management
- ISO
- Sarbanes Oxley
MAXLife helps Life Sciences companies reduce the time and effort
required to maintain compliance, and enables them to
cost-effectively demonstrate that they meet the processing, safety
and tracking standards required by law.
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