Vendor selection
The options available for LIMS (Laboratory Information Management Systems) and other laboratory systems are constantly evolving. Let us help you by providing our expertise to guide you through the process:
- Determine business and user system requirements
- Define vendor selection criteria
- Determine a short list of vendors
- Provide the vendors with a demonstration checklist/script
- Navigate the vendor demonstration process
- Oversee pilot implementations and testing
- Manager final vendor selection
We are here to answer your questions and ensure the vendor(s) do as well.
Quality Oversight
Internal software development has many challenges, we can assist with providing quality oversight and procedures to standardize operations and meet applicable regulations. We can also assist with managing contract developers for externally developed software projects.
Validation
Do you currently generate the optimal amount of software validation documentation? We can help to streamline your validation processes and provide additional resources where needed for project support. Internal processes, SOPs, and templates can be developed for optimization, standardization, and flexibility while adhering to applicable regulations.
Project Management
Project management is both a skill and an art, we can provide technical project management expertise to provide realistic project plans and deliverables. Laboratory systems have many variables which must be considered in both the project plan and budget.
Business Strategy
From startups to established companies, sometimes you need someone from the outside to provide a fresh perspective and help guide you on the best ways to optimize processes and meet regulations. We can assist with developing overall strategies and perform periodic check-ups.
Risk Assessment
Risk assessments are critical during software development and deployment to determine the extent and focus of testing. This applies directly to validation but is also used to define the test plan(s). Risk Assessment and test plans also define when and where to use various testing elements such as scripted, unscripted, and automatic test scripts. We can assist with developing plans, procedures, templates, and testing protocols.
Data integrity
Data Integrity (DI) is a hot topic, but it relies on solid QMS (Quality Management Systems) and IT processes. We can provide DI project management and DI remediation for enterprise, laboratory, and manufacturing systems.
Standard Operating Procedures (SOPs)
Don’t reinvent the wheel, we have a library of SOPs and other documentation that we can customize for your industry and business.