Situation

A midsize pharmaceutical contract development and manufacturing organization (CDMO) was upgrading from Thermo Scientific SampleManager LIMS version 10 (which was off support) to SampleManager version 21. The CDMO was no longer able to manage the complexity of their organization within the existing software. The client initially engaged the original implementation consulting company to do the upgrade; they were experienced and trusted. The CDMO also hired CSols as the project manager and the business analyst (BA), as well as validation resources. A global consultancy acquired the upgrade consulting company mid-project, and the assigned resources were changed.

The global consultancy was hiring lower-skilled employees who were unqualified to handle the SampleManager upgrade. Internal client resources were already stretched thin, so the client asked CSols to expand our project management services for better project continuity. CSols addressed various issues for the client and managed to salvage the upgrade (albeit through numerous change orders).

Objectives & Challenges

Organizations with off-support LIMS versions eventually are steered toward an upgrade. This client wanted SampleManager version 21 because it has additional functionality that was not available with version 10.

The upgrade should have taken six months, but because of the decrease in in-house SampleManager expertise at the global consultancy, particularly around validation requirements, the project has lasted years. The original purchase order did not include test scripts, which resulted in many corrective and preventative actions (CAPAs) and deviations. The upgrade eventually started over from scratch.

CSols' Role in the Solution

CSols resources on this project filled the following roles:

• Project Manager
  • Delegated tasks by skill level and kept the project on track
• Business Analyst
  • Worked with client subject matter experts (SMEs) to identify user requirements, perform a gap assessment and risk assessment, and update standard operating procedures (SOPs) and the configuration specification
• Validation Experts
  • Executed the validation process, populated the client's validation document control system, and managed the deviation/CAPA documentation process

Benefits

Adding project management, business analysis, and validation expertise from CSols gave the client the resources needed to drive the project to completion. When in-house staff lack the bandwidth or expertise to know what an informatics project requires, CSols can help. The expanded functionality available from SampleManager version 21 will provide the client with much better visibility of their laboratory data. Additionally, the client now has a fully populated validation document control system where their SOPs are readily accessible.

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