Case Studies

Operations

Inventory & order management optimization

Objective: A repeat life sciences tools company client, needed assistance with optimizing processes related to inventory management to increase order fulfillment rates. 

Approach: Performed gap analysis to determine areas of improvement within inventory and fulfillment management activities. Created a database detailing sub-component and kit relationships and available quantities based on input from the fulfillment team. Worked closely with data scientists to develop an automated solution based on the structure of the sub-component/kit database.

Results: Order fulfilment rates increased by utilizing the optimized process and the development of the accurate inventory database to assess real-time quantities. Also, the fulfillment team was able to proactively schedule orders based upon available inventory. The data scientists utilized the proposed database and incorporated additional metrics specific to various departments for subsequent analysis activities. bioTsys Consulting services were used for several projects within this company.

Reagent kitting assessment

Objective: A life sciences tools company, a repeat client, requested an assessment to identify a reagent kit plan to house inventory of frequently ordered kits and sub-components to meet the growing demands.

Approach: Compiled list kits and sub-components. Worked with the financial team to gather sales information from previous years relevant to reagent kits with the most revenue as well as higher order frequency. In-house manufacturing team provided sub-component specifications related to shelf-life and storage temperatures. 

Results: The findings were presented to the manufacturing and assembly teams  which included proposed: kit quantities, frequency of assembly and special considerations for sub-component specifications. The manufacturing team utilized the proposal to conduct additional optimization of sub-component specifications to increase the feasibility of implementing a reagent kitting plan. bioTsys Consulting services were used for several projects within this company.

Finished Product Packaging Management

Objective: A repeat life sciences tools company client, needed support managing new product packaging projects to avoid inconsistencies in designs and product delays. 

Approach: Conducted meetings with reagent manufacturing, marketing and new product managers to obtain packaging requirements and specifications. Managed packaging designer mock-up creation and in-house testing to adhere to strict deadlines. Provided design feedback based on usability, assembly requirements and aesthetics. 

Results: Final packaging exceeded expectations and the project was completed within the specified deadline. The activities related to; requirements, interactions with designer, in-house testing and final approval was documented in a new SOP. An in-house manager was designated and trained on the procedure. bioTsys Consulting services were used for several projects within this company.

Facilities

Lab Planning & Design

Objective: A life sciences tools company, a repeat client, was in the process of expanding lab operations to a facility in another state and requested management services related to recommendations on site plan, technical client representative and initial chemical safety and regulatory assessment.             

Approach: Met with stakeholders and assessed lab and office needs. Reviewed lab layout and provided necessary recommendations to meet workflow requirements and specifications. Gathered information from local and federal regulatory bodies to create a chemical safety plan and permitting assessment. Managed vendor selection activities pertaining to custodial, furniture and lab services. Provided project management services relative to construction activities, deliverables and timeline adherence.

Results: The client was satisfied with the completed BSL-2 facility and in-house services to sustain lab operations. The chemical and permitting assessment was utilized in-house to complete required compliance documentation. bioTsys Consulting services were used for several projects within this company.

Facility & Chemical Inventory Assessment

Objective: An emerging single-cell sequencing company requested assistance evaluating a potential lab facility to ensure it met the current needs as well as future needs based on company growth.

Approach: Met with company CEO to discuss lab requirements and potential growth avenues. A chemical inventory assessment was recommended to ensure space would accommodate desired quantities and types. Worked with scientists to gather information based on workflows and technical protocols.

Results: Client secured lab facility based on evaluation and satisfaction of lab requirements. Chemical assessment was provided along with local and federal permit guide to be used in-house for compliance activities and documentation.

Facility selection and lab planning 

Objective: An emerging biotech research partnership company required facility services to secure a local space with amenities suitable for adequate lab operations while reducing start-up time.

Approach: Met with CEO to determine facility needs, square footage, location and amenities. Conducted facility searches utilizing professional networks as well as online resources. A dynamic summary document was created to keep stakeholders up to date on available facilities as well as comparison charts. 

Results: Client secured location which exceeded initial expectations based on summary documentation and recommendations. A list of area service and utility providers were also supplied to client to assist with vendor acquisition. 

Technical Writing

Deviation documentation management

Objective: A repeat life sciences tools company client, needed assistance with optimizing processes related to the protocol deviation approval. 

Approach: Obtained current procedure details from stakeholders in various departments. Developed process workflow detailing; process initiation, subsequent actions, notifications and approval steps. Incorporated feedback from key stakeholders review. 

Results: The procedure streamlined the deviation process and was useful to accurately document changes. Provided training sessions on the overall process as well as individual responsibilities. Key stakeholders were also able to utilize the process to discuss alternative solutions to the proposed deviation. bioTsys Consulting services were used for several projects within this company.

Warehouse documentation evaluation

Objective: A life sciences tools company, a repeat client, solicited services to create a documentation catalog to encompass all operations within warehouse department and promote up to date training instructions. 

Approach: Conducted meetings with warehouse personnel to obtain current workflow and perform process gap analysis. Drafted SOPs pertaining to packaging, assembly, receiving, non-conformance, and shipping (including dangerous goods). 

Results: Documentation was reviewed by team and ultimately included in larger company policy initiative. bioTsys Consulting services were used for several projects within this company.