Background: Sample management is a key R&D process for any Pharmaceutical or Biotechnology organization and can include a wide range of types, including chemical compounds, cells, biologics and clinical. Companies build their sample collection through acquisitions, external vendors and internal sources, and have both conventional and sophisticated methods to register, track, and audit them. Conventional methods often involve storing and retrieving samples, sometimes numbering in the thousands, in manually operated freezers or storage cabinets and tracking is usually done with simple IT systems and/or tracking sheets for sign-in and sign-out. Sophisticated methods include automated or semi-automated freezers and stores coupled with IT systems to register, track, order and audit samples.
Challenges in sample management: In most labs, samples tend to accumulate in different areas, leading to cumbersome methods for tracking and management. When a user requests a particular sample, personnel will access it through a manual or automated method to dispense and fulfill the request. Often, the process involved in fulfilling such a request is very complex. Sample management personnel routinely come across various challenges in their day-to-day work, including:
• Processes which have been built around outdated/obsolete technology or IT systems
• Routine IT and automation upgrades performed around inefficient processes instead of around redesigned and improved processes
• New processes and standard operating procedures that have been created without utilizing lean thinking
• High priority process improvement projects getting shelved due to resource constraints
• Lack of exposure to operational excellence concepts among scientists/lab leaders
Solutions: Often, opportunities are available to change or improve processes when the amount of samples grows. Also, when the process of sample management is inefficient, opportunities can be created to modify the processes by presenting the right justification. Solutions to these challenges can be achieved in the following ways:
• Gap analysis: It is important to note that sample management processes often interact with IT systems supplied by different vendors. These IT systems could be within a group or shared among other groups and partners. Performing a gap analysis, i.e., identifying the downsides in the current processes by taking into account its interactions with all the IT systems is a key to success. Such a detailed analysis will provide a roadmap to build an ideal system and process.
• User requirements gathering: Prioritize the issues and document the requirements in an extensive form, preferably with the help of a certified project manager. Proposed process changes could pose a scientific threat to sample integrity and care must be taken to analyze the proposed changes to avoid such a compromise. If necessary, scientific experiments should be conducted to alleviate any concerns.
• Partner/Internal discussion: Often, proposed process changes will have an impact on an upstream group that registers the sample in the inventory as well as the downstream group that requests sample from the inventory. It is essential to discuss the requirements with the company’s internal groups and/or the external partners to identify pitfalls very early.
• Resource allocation and project rollout: Identify people within and outside the group who can take part, support and test the outcome of the project. Work with a certified project manager to set appropriate timelines and goals. Often resource allocation in sample management groups become a challenge due to the day-to-day production activities that need to be accomplished. Hence it is critical to plan for a budget allocation to hire temporary help for performing production work.
The above mentioned solution also allows the groups to strategically re-align their operational approach in sample management, considering the challenging landscape in R&D. This also presents an excellent opportunity for the people in these groups to learn and grow.
I will be very interested in your feedback and please feel free to share your experience or thoughts on different approaches.
Subbu Ramanathan
Background
Sample management is a key R&D process for any Pharmaceutical or Biotechnology organization and can include a wide range of types, including chemical compounds, cells, biologics and clinical. Companies build their sample collection through acquisitions, external vendors and internal sources, and have both conventional and sophisticated methods to register, track, and audit them. Conventional methods often involve storing and retrieving samples, sometimes numbering in the thousands, in manually operated freezers or storage cabinets and tracking is usually done with simple IT systems and/or tracking sheets for sign-in and sign-out. Sophisticated methods include automated or semi-automated freezers and stores coupled with IT systems to register, track, order and audit samples.
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