Project Tracking for Research and Development

Dynamics AX customization case study

Company

A leading provider of drug development services focused on research, analytics, and development of active pharmaceutical ingredients (APIs). The Company is located in Europe and operates in both European and American markets. It was acquired by a global manufacturer of chemicals along with another European chemical research and development laboratory. They now operate as a part of the Pharmaceutical Services division aimed at fastening the process of drug development and commercialization.

Business situation

The Company was using disparate data systems to support research, clinical testing, analytics, and other activities. It needed an integrated solution to efficiently manage projects, from receiving requests to establishing synthesis schemes, clinical testing, and manufacturing.

The company needed to track all stages of the APIs development to provide accurate estimates to the customers and efficiently manage the project budgeting. It was also important to gather detailed information on all substances and share it both internally and externally.

Challenges

The Company decided to implement Axapta 2.5 to address its needs in business integration and project tracking. The Company partnered with Axiopea to customize the system. The solution’s standard functionality has been modified to fit the industry-specific needs. Later, the system was upgraded to Axapta 3.0.

While working on this project, we faced a number of challenges:

• The functionality had to be implemented to track all samples created and tested in the laboratories. Each substance should have multiple parameters (e.g., raw materials, final products, test results, hours spent on research) to enable the integration of scientific viewpoint with the project management information.
• Project planning and tracking had to be tailored to the Scientific Research and Development.
• The Company should be able to provide accurate cost estimates and avoid cost overruns.
• The system had to be integrated with the 3d party systems and custom software. The head company used SAP, while another R&D laboratory had an extensively customized Axapta. There were also some vertical solutions needed to interact with the customers and the regulatory bodies.

Solution

The solution allows the Company to meet the time and quality deliverables for the pharmaceutical projects. It helps bring together the scientific picture and the project management angle in order to efficiently track research and development, provide accurate cost estimates, and fasten time to market.

We have created the following functionality:

1. Knowledge base of pharmaceutical ingredients

All data on pharmaceutical projects is stored in a knowledge base. It covers information on all substances the Company has ever developed at every stage of their development: raw materials, intermediates, reagents, final products, etc. It also describes activities that were carried out during research, development, and testing.

The knowledge base allows converting the information into a synthesis scheme-a sequence of steps needed to produce a chemical. It serves as a solid foundation for the project planning, quality management, and product manufacturing.

2. Project planning and tracking

We developed a Project Planning Calendar-an Axapta add-on that allows building a project plan from the synthesis scheme. The calendar features

• Creating a work breakdown structure, thus decomposing a project into smaller phases
• Planning activities for each step, from research to production
• Estimating time, cost, and resources
• Building a Gantt Chart based on that information
• Reporting the results

The Calendar has a project timesheet tailored to the needs of Scientific Research and Development. More than half of the Company’s employees have science degrees and work in the scientific institutions. Therefore, many of the personnel work part-time or have irregular working hours. The solution allows calculating the working hours based on the achieved results, not the hours spent at the laboratory.

3. Project budgeting system

The project budgeting functionality allows to associate resources, both human and equipment, with cost per time period. The estimates are passed from the chemists to the sales staff, who can now issue quotes in Axapta. The quotes include timelines, sales price, per hour rates, and other parameters. The Company can now compare estimated and actual costs and efforts, analyze the results at any project phase.

4. Integration with company-wide and external applications

The system was integrated with various software and applications:

• Integration with SAP and company-wide CRM to enable a two-way communication with the head office.
• Merging of two customized Axapta systems to share scientific research results with another R&D laboratory acquired by the head company.
• LIMS (Laboratory Information Management System) and CDS (Chromatography Data System) integration to meet compliance regulation for the cGMP as established by the FDA and provide information and analytics to customers.

Results

Customized to suit the needs of research and development in pharmaceuticals, Axapta allows the Company to efficiently plan and track projects, reduce cost overruns, and meet deadlines.

With Axiopea’s services the Company was able to

• Track and control all substances it uses and develops
• Make accurate project forecasts and turn them into estimates
• Improve reporting
• Track material and personnel expenses
• Meet the compliance regulations of the FDA and European bodies
• Share information and provide analytical services to customers

The improved project management and a complete control over chemicals allow the Company to move products from the laboratory to the commercial use faster and more efficient.

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