Case Study - LIMS

Introduction:

Executive Summary

LIMS (Laboratory Information Management System)

Our client, a Pharmaceutical Contract Manufacturing company had a requirement to automate the paper based laboratory process to enhance competency. LIMS stands for laboratory information management system and represents a distinctive software package and database that stores and manages laboratory data, work flow and specialized processes like sample life cycle. In its basic form, it is applicable to R&D labs, QA labs and many more.

Business Challenge

• Pharmaceutical Quality Control Laboratories have an important function in raw material evaluation and in production and can significantly impact overall manufacturing performance.

• Lack of Built in in checks at potential error points increased manual errors. There is an increased cost associated with failure of lab process.

• Lack of a system that is able to manage data for a wide range of analytical techniques for both the raw materials and finished products.

• The Lab relied on semi-manual procedures and couldn't easily generate useful analytical reports or produce electronic data deliverables (EDDs).

• Lab found it difficult to manage the workload efficiently.

Solution

• Custom made Laboratory Information management system catering to five primary criteria : 1) Breadth of feature set 2) Intuitive workflow and ease-of-use 3) Integration capabilities 4) Minimal ongoing maintenance and 5) Affordability.

The core function of LIMS has traditionally been the management of samples. This typically is initiated when a sample is received in the laboratory, at which point the sample will be registered in the LIMS. Some LIMS will allow the customer to place an "order" for a sample directly to the LIMS at which point the sample is generated in an "unreceived" state. The processing could then include a step where the sample container is registered and sent to the customer for the sample to be taken and then returned to the lab. The registration process may involve accessioning the sample and producing barcodes to affix to the sample container. Various other parameters such as clinical or phenotypic information corresponding with the sample are also often recorded. The LIMS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column.

Change Management

As a consultant we have always looked out to offer what the client wants, but our role doesn't end there. We also make sure that we are well received internally among the users of the system. Internal acceptance helps us to train, deploy the system end to end. Change management is very client-centric, and our aim is to build acceptance thereby further reducing business pain areas. Change can be unsettling so we as technology partner needs to be a settling influence, which we have successfully achieved.

Key Participants of the System

Key Results

Report Generation : The solution provided a very quick way to generate reports for certain tasks such as Certificates of Analysis, monthly reports, trending, and validation paperwork. Very fast generation of validation documents compared with the old procedure was achieved.

Productivity : Productivity increased due to an intuitive workflow that closely mirrored the basic needs of the lab but automated many of the functions. Lab staff could move seamlessly from client information to project creation, work order entry, sample processing, detailed analysis, and reporting.

Quality control : Quality control also improved because of increased integration. eSoft LIMS came pre-loaded with 85-90 percent of the instruments used in the Lab and the balance were configured during the implementation process.

Data Redundancy : eSoft LIMS helped achieve less repetitive and error-prone data entry.

Compliance : Regulatory compliance became easier because the Lab gained the ability to produce EDDs, analytical reports and quality control.

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