ERP Solutions for Life Sciences

powered by Microsoft Dynamics AX for Life Sciences


Overview

The life sciences companies that develop and bring to market pharmaceuticals, biotechnology, and medical devices have the same need for good enterprise resource planning (ERP) that all manufacturers have. An effective ERP solution can result in better resource management and more efficient operations. And that can mean a healthier bottom line.

For members of the life sciences sector, an additional hurdle must be cleared before profitability can be achieved: regulatory approval. Companies that can't pass muster with the U.S. Food and Drug Administration (FDA) will find themselves paying huge lost-opportunity costs for non-compliance. ERP solutions based on Microsoft Dynamics AX (formerly Microsoft Business Solutions-Axapta) could help improve compliance and reduce costs.

Industry Challenges - The FDA's manufacturing mandates (cGMPs and 21 CFR Part 11)

The ideal life sciences ERP solution is one that embraces cGMPs while also leaving the electronic audit trail required by 21 CFR Part 11. It's a safe bet that in the near future any ERP solution designed for the sector will take into account and effectively navigate the regulatory landscape. To do less will be to fail.

Why Microsoft Dynamics AX for Life Sciences?

We consider the ERP solution, which meet the FDA's cGMPs and 21 CFR Part 11 requirements for our clients, from SAP, Oracle, and Microsoft. We select Microsoft Dynamics AX for Life Sciences based on its broad functionality, flexibility, ease of use, and low total cost of ownership.

Microsoft Dynamics™ AX for Life Sciences is a customizable, scalable, and integrated business application platform designed for companies in the life sciences industry. Introduced in 2005, Microsoft Dynamics AX for Life Sciences is a "validated" ERP solution, meaning it has been certified by a third party as complying with FDA mandates, including cGMPs and 21 CFR Part 11. This saves life sciences manufacturers from having to pay a significant amount of money to have consultants create the necessary documentation from scratch. It also can help life science companies connect with their business partners, optimize business processes and gain competitive advantages, together with a partner or ISV-provided vertical solution.

In the life sciences sector, where the costs of entry and of failure are unusually high, any solution that speeds the regulatory approval process confers a real competitive advantage. Microsoft Dynamics AX for Life Sciences achieves that by delivering out-of-the-box compliance with FDA manufacturing standards. That the solution combines validation documentation with best-of-breed ERP functionality represents a true step forward in life sciences manufacturing.

A key component of the Microsoft Dynamics AX for Life Sciences platform is validation documentation. A crucial part of any validation process is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The solution's validation documentation verifies compliance with regulatory requirements and allows significant simplification of the customer's validation efforts.

"Our research shows that life sciences manufacturers pay a significant amount of money to have validation consultants create this documentation from scratch," said Melissa Paulik, senior life sciences industry product manager for Microsoft Business Solutions. "By providing this documentation through our business partners, we are making a life sciences industry solution affordable to the mid-market segment."

Another key feature of Microsoft Dynamics AX for Life Sciences, according to Paulik, is 21 CFR Part 11 compliance functionality.

Support cGMPs and Regulatory Compliance

Microsoft Dynamics AX for the Life Sciences & Pharmaceuticals Industry supports cGMP requirements including electronic quarantines, quarantine release by user and material type, printed material control / obsolete components, lot control / segregation, lot tracking, and drug and hazardous reconciliation. The solution documents standard processes, and tracks and logs operations and results to support your detailed reporting requirements. Features such as traceability, lot tracking and traceability, production statistics reporting, specification management and change management provide the control and predictability you need to detect and address exceptions early, and consistently produce the highest quality products. By tracking items from cradle to grave, your company can implement effective recall procedures with complete forward and backward traceability of any material.

Improve Production Planning and Inventory Management

Life sciences and pharmaceutical manufacturers handle active ingredients that are often very expensive in small quantities so they are often reused and/or recycled several times. Microsoft Dynamics AX for the Life Sciences & Pharmaceuticals Industry models the processing and reprocessing of such materials. It also helps minimize over-runs and short-runs, and uses shelf-life tracking to take expiration dates into consideration during production and into the distribution process. You can also centrally manage co-products and by-products in your formulas or recipes and always know the correct inventory status for any given item.

History

Microsoft Dynamics AX was originally developed as Axapta in Denmark before Damgaard was merged with Navision Software A/S in 2000. The combined company, initially NavisionDamgaard, later Navision A/S, was then ultimately acquired by the Microsoft Corporation in the summer of 2002. Introduced in 2005, Microsoft Dynamics AX for Life Sciences is a "validated" ERP solution, meaning it has been certified by a third party as complying with FDA mandates, including cGMPs and 21 CFR Part 11.

Core Features

  • cGMPs compliant manufacturing processes, including integrated Quality functionality
  • Electronic Records and Signatures, configurable as standard across all transactions
  • Integrated Financials and Manufacturing (process or discrete)
  • Defined best practice business processes, enabled by flexible workflow
  • Close integration with other Microsoft products such as Office, SharePoint etc
  • Built in, pre-configured Business Intelligence

Implementation

Business & Decision build on these core features and use their industry specific implementation and ERP validation accelerators (aligned with Microsoft's Sure Step 2.0 implementation methodology and GAMP® 5) to provide either:
  • Fixed scope, fixed price implementations for small Life Sciences companies able to implement standard business processes
  • Client specific solutions, for Life Sciences organizations with specific cGMP requirements

Differences between Microsoft Dynamics AX and Microsoft Dynamics AX for Life Sciences

The main difference between Microsoft Dynamics AX 4.0 and Microsoft Dynamics AX for Life Sciences is that Microsoft has documented a manufacturing process based on Microsoft Dynamics AX 4.0 that supports cGMP requirements. Microsoft has added validation-mandated functionality such as electronic signature, which requires tight integration with core Microsoft Dynamics AX technology. Microsoft has also added specific update and change control processes necessary for such an environment.

The following features have been added specifically for Microsoft Dynamics AX for Life Sciences:
  • Electronic signature
  • Improved BOM control (removes ability of users to edit BOMs after they have been approved)
  • Improved production status control
  • Improved route control
  • Improved traceability of unauthorized login
  • Improved feature configuration control
Note that all these modifications to the core functionality of Microsoft Dynamics AX 4.0 are mandated by requirements enforced by the FDA and other regulatory agencies. The changes to the functionality will be manifested in any Microsoft Dynamics AX module in which the functionality appears.

All standard Microsoft Dynamics AX 4.0 modules can be used with Microsoft Dynamics AX for Life Sciences. The specific Microsoft Dynamics AX functionalities that have been modified to help companies comply with cGMPs will operate consistently across the entire solution and all installed Microsoft Dynamics AX modules.

Microsoft Dynamics® ERP & CRM functionalities

  • Infrastructure
    • Globalisation
    • High-performance computing
    • Integration
  • Compliance
    • Adverse event reporting
    • cGMPs
    • ISO
    • Part 11
    • Document management
  • Research and Development
    • Clinical trials
    • Collaborative design and engineering
    • LIMS
    • Product life cycle management
  • Sales and Marketing
    • Customer relationship management and sales
    • Force management
  • Manufacturing Operations
    • Business intelligence
    • Formula and batch management
    • Revision Management
    • Serial / Lot genealogies
  • Supply Chain Connectivity
  • Customer Service
    • Field service
    • Warranty Tracking
  • Customer Relationship Management
    • Develop, target and implement marketing campaigns
    • Manage sales leads, opportunities and accounts
    • Forecast and sales analytics
    • Customer service management

Notice

Note that no vendor can guarantee the successful validation of any given Life Sciences implementation. Compliance with regulatory agency requirements depends in a large part on the processes or standard operating procedures within the customer organization. Microsoft Dynamics AX for Life Sciences, along with a partner or ISV-provided vertical solution, can support a customer’s compliance strategy but the ultimate responsibility continues to belong to the customer.