Computing Solutions Inc.’s Configuration personnel led by a CSI Project Manager will join with knowledgeable members from your company to build a LIMS Team. The LIMS Team will work together to build a system that leverages the flexibility of LabSoft LIMS while keeping in mind GLP and Best Practice concepts. The LIMS Team will participate in scheduled weekly conference calls to discuss and monitor the progress of action items. The weekly meeting will often include live remote demonstrations of your actual LabSoft LIMS configuration.
Project methodology:
- All members should have a clear understanding of the project’s short term and long term goals as defined in the scope of the Contract.
- Routine scheduled meetings with dedicated participation.
- CSI uses Agile Project Management which uses iterative cycles of proof of concept that are created and tested in a timely manner.
- Validation:
- IQ (Installation Qualification) Validation is supplied by CSI
- OQ (Operational Qualification) Validation is partially supplied by CSI in the form of the OQ Table Validator. The remaining OQ Validation requirements are the responsibility of the Customer (e.g. test scripts).
- PQ (Performance Qualification) Validation is the responsibility of the Customer.
Project risks:
- Insufficient IT knowledge and responsiveness:
- Server procurement and configuration
- Establishing and maintaining connectivity for CSI
- Basic SQL Server management knowledge (e.g. backup/restore and running scripts)
- Customer Team member issues:
- Lack of consistent members
- Turnover
- Lack of active participation
- Failure to answer questions accurately and in a timely manner
- Lack of authority to make decisions
- Lack of Customer resource commitment
- Scope creep
