Data Curation
Specializing in GxP Execution Systems (MES & LIMS) and Operation Technologies
Dynamic & Thoughtful Design
We are focused on the implementation of execution systems (MES, LIMS, & LES)
for use in the manufacturing and analytical analysis of biological products.
We are intent on providing solutions that ensure the necessary information is permenantly
memorialized within the manufacturing process and laboratory testing lifecycle.
This includes the capture and aggregation of information created during batch execution,
assay execution, and supply chain updates. Additionally, we find it very important to
assist in the tracking of process and testing deviations (exceptions) monitoring, and
the aggregation of instrumentation (equipment) runs to reinforce our documented outcomes.
Our Skill Set
Consult & Define
Process Maps
Constructing Business Cases and Project Plans
Preparing Requirements
OT Project Management
Develop & Deploy
Workflow Development
Architecture Drawings
Cybersecure Infrastructure (On-Prem or IaaS)
Computer System Validation (IT-CSV)
Maintain & Service
Regulatory Readiness and Response
Change Controls & CAPA Management
Data Management & Reporting
Managed Services