Data Analytics and Investigations 

Process development, tech transfer and commercial manufacturing generate large amounts of parameter, attribute, and change control data. There are opportunities to convert that data into information and knowledge while examining processes and transforming their performance. Light Pharma utilizes data management, information & knowledge management, process mapping and simulation to conduct complex investigations and to guide clients on their investigations.

Data Management

We have analyzed data from tens of thousands of batch records. This analysis has been performed for compliance, problem-solving investigations, and proactive identification of areas of low capability. The associated analysis has regularly included analysis of variances/exceptions, evaluation of data consistency, evaluation of data quality and quantity, trend and pattern analysis and underlying cause analysis. We have developed proprietary pattern recognition and data mining software tools that enable companies to extract the few key pieces of information from large volumes of data. Active learning methodologies have been developed that allow companies to enhance the rate of data mining and knowledge extraction.

Root Cause Investigations

Inadequate root cause investigations of deviations is a common pain point within the life sciences and healthcare industries. Light Pharma personnel have demonstrated expertise that includes analytical methods, manufacturing unit operations, sterile operations, raw material assessment, and multivariate data analysis. The combination of these areas of expertise has enabled problem solving of deviations of complex origin (and an ability to provide an external review of investigation work-in-process). Light Pharma has resolved many repeat root cause investigations, identified the impact of the root cause on other similar situations, substantiated rationale for associated actions, and provided quantitative criteria for checking the effectiveness of the associated actions. In addition to providing this technical leadership on investigations, Light Pharma has extensive experience training clients on conducting and peer-reviewing such investigation activities themselves to build the expertise in-house. Light Pharma has built software tools that utilize data and process history to automate intelligence for investigations which has enhanced the substantiation and speed of root cause investigations.

Information & Knowledge Management

Effective measurement of how well your processes are performing and improving helps relate the information and knowledge artifacts to business outcomes and performance management. Organized and readily accessible knowledge can enable more efficient and effective problem solving and investigations.

Process Mapping and Simulation

Mapping and simulation of the processes that are determining your performance and redesigning these processes when appropriate can help identify bottlenecks and hot spots, promote "learning before doing”, capture diverse pieces of information in a single framework and communicate concepts across the organization. Process simulations are a means to perform "what-if" type scenario analysis and to evaluate potential benefits from a new way of doing things.