USDM Life Sciences laboratory consulting professionals are experts in the laboratory environment with hands-on pharmaceutical experience to perform laboratory assessments identifying opportunities to streamline operations, reduce areas of potential exposure and improve overall lab performance and productivity. Our best practices approach provides a 360 degree evaluation of your lab to help you achieve the simplicity and consistency needed to assure compliance with regulatory requirements.
USDM Life Sciences' laboratory system implementation and validation practice focuses on rapid deployment, improved quality and reduced risk-based validations for all of our engagements.
We achieve this through:
- Experience – decades of lab system installation and validation projects.
- Risk-based approach to validation – a tried and tested method where the focus of the validation is on critical functions and modules that impact compliance data. All other functions that indirectly affect compliance data are minimally tested. This is documented in a detailed Risk Assessment.
- Validation Accelerator Packs (VAPs) for most standard lab systems. These VAPs are a complete set of content-rich validation document templates for the system based on common, core requirements for life science companies.
The VAP difference:
Each VAP lists requirements and tests for core and common system functionality and can be leveraged to build the validation documentation suite. The USDM VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance.
Among the common functionality (modules) covered in our lab systems VAPs are:
- System access and security
- Electronic signatures
- Audit trails
- Workflow States
- Set up and maintenance of methods
- Data acquisition
- Data storage and retrievability
- System suitability
USDM Life Sciences supports the following Laboratory System applications: