A specialty chemical manufacturer plans to implement a new Laboratory Information Management System (LIMS) globally.  The entire project consists of developing the functional specifications for the LIMS, list of user specifications, choosing the appropriate LIMS, configuration, training, and finally implementation in the U.K., Germany, and North America.

The team consists of the Business Task Leader, IT project personnel, and quality management from six (6) company sites.  The team is responsible for the development of the functional specifications based on the requirements of each site and rates them according to importance.  Four (4) LIMS are rated based on the functional specifications.  This includes the current obsolete system used by the corporation.  A LIMS is chosen and the request for capital is submitted.

The project consists of several key stages prior to implementation.  Determining the actual configuration and functionality is the most time intensive part of the team.  Language conflicts with the software set-up usually occur during this time period.  Also, some sites are regulated by the FDA while other sites are purely industrial.  The level of checks and approvals has to be carefully considered.  This is covered in the set-up of the specification part of the LIMS system.

Once the configuration starts, training on upper-level LIMS users is initiated.  A primary site is utilized for the training on the basic functionality of the LIMS system and their role in maintaining the system at their site.  This group will be responsible for assisting with the implementation and training at their site.

The result is a LIMS system that is functional for all aspects of the business.  Since the users have input from start to finish, the implementation is smooth and there are no surprises.  This system required validation due to regulatory requirements.

Key Tasks for a Successful Implementation:

1.     Approval of the Validation protocol

2.     Functional Specifications – Extremely Important – based on the team’s requirements from back-ups to nomenclature.  Required for validation testing.

3.     User Specifications – These are important for final buy-in from the customer and are required for validation testing.

4.     Rating the LIMS vendors/systems.

5.     Developing the configuration

6.     Configuration

7.     Testing

8.     Training

9.     Implementation

10. Validation Summary and Approval

11. Lessons Learned