Situation

The Tobacco Control Act (TCA)was enacted on June 22, 2009. This regulation requires tobacco manufacturers(> 350 employees) and importers to adhere to Good Manufacturing Practices(GMP) and/or Hazard Analysis and Critical Control Point Methodologies to ensure the safety of their products. Additionally, data and information on ingredients, levels of ingredients, and packaging testing data would need to be maintained. Last, TCA empowered the FDA to audit the tobacco manufacturers and importers every two (2) years.

A large Tobacco Manufacturer was concerned that their in-house developed, LIMS-like system for its manufacturing and R&D organizations would not support the data and information needs or more stringent regulatory requirements that the TCA mandates. They decided to investigate and select a new, commercially available LIMS to support their manufacturing operations. However, as they got into the selection process, they realized that they did not have the right internal resources to be successful. They needed professional, specialized help to meet their goals and objectives. The company, therefore, engaged CSols, Inc. to help them choose their LIMS. CSols was selected based on our LIMS and Regulatory expertise as well as our best practices–derived, proven LIMS Selection Process and track record of successful LIMS Selection projects. Another factor was our flexibility, as we were willing to adjust and amend our standard LIMS selection process by leveraging as much as possible of the LIMS requirements and needs already gathered by the company.

Objectives

The main objective of this endeavor was to choose an informatics solution that could support the needs and requirements of the company’s Production, Quality Assurance (QA) and Laboratory organizations. Additionally, the informatics solution selected needed capabilities and features to support current regulatory needs as dictated by TCA and flexibility to handle changing regulatory needs going forward. For example, TCA did not cover e-cigarettes at the time of this work. The LIMS selected and the informatics solution implemented needed to support the changing and expanding regulatory compliance needs of the company.

Challenges

Several challenges and obstacles arose during the course of this project. The client was investigating several laboratory data systems (i.e., chromatography data system) for adoption in their organization. Additionally, the IT department assessed their upgrade pathways for all laboratory desktop and server systems.

To overcome these challenges, additional LIMS requirements addressing system interoperability and integration had to be explored and included in the User Requirement Specification (URS). We also included the best options for the most likely future scenarios with input from the client team in their “Future State” documentation and report.

A very aggressive timeline was another major challenge that was overcome in this project. The company had already expended considerable time and effort in documenting their current state and requirements. To make the timeline, CSols adapted our informatics solution selection process to leverage what had already been done and documented. Thus, we eliminated some data gathering mechanisms, such as stakeholder one-on-one interviews. Instead, an intense requirement review process, a business process briefing, an IT briefing, and an in-depth facility tour were performed. The remainder of the strategic selection process followed CSols’ established methodologies. Luckily, the client’s project team was fully engaged and willing to provide documentation and answer questions during the “To-Be” workflow and process flow documentation process. Their ready participation allowed us to complete the “To-Be” flows in a manner that met CSols’ standards.

CSols’ Role in the Solution

We provided laboratory informatics strategic planning services, business analysis, and laboratory and regulatory expertise in the form of two Senior LIMS Consultants to act as Client Services Manager and Business Analyst, to support the project and make it a success.

The effort included the following key tasks and deliverables:

• Developed and maintained the Project Task List
• Created and delivered As-Is workflows based on briefings and document review
• Conducted To-Be workshops
• Developed and delivered User Requirements Specification (URS)
• Developed and delivered Request for Proposal(RFP) document
• Managed the RFP process
• Assisted the client with analysis of RFP responses
• Managed the vendor demo process
  • Created vendor demo scripts
  • Analyzed vendor demo results
  • Recommended next steps

Benefits

• The customer regained momentum for the project by engaging with CSols
• The project timeline was satisfied and full documentation of As-Is and To Be states, as well as all needs and requirements was developed
• The customer received a quantified vendor results for both the RFP and the vendor demos, through the LIMS selection process, to help the customer make a supportable business decision
• TCA regulatory and data requirements would be supported once new LIMS is fully implemented
• New LIMS can easily integrate and support manufacturing, business, and laboratory systems