Specialized knowledge and expertise in Information Technology, Quality Assurance and Laboratory Practices is required to successfully implement and maintain Laboratory projects and Informatics systems (LIMS, ELN, SDMS, CDAS, etc) within the pharmaceutical, biotech, chemical, food and environmental industries.
Our staff is trained in the SDLC methodologies and provides solutions that are 21 CFR Part 11, EU Annex 11, and cGxP compliant based on industry best practices such as GAMP5 and ALCOA+. All of our projects and consultants are managed by highly trained professionals with laboratory informatics, laboratory system and validation experience.
Our offerings include Laboratory Compliance Assessments where our staff can perform a thorough review of the Laboratory systems and their associated data paths to determine alignment to Compliance and Data Integrity Standards. Creating a structured compliant laboratory space and providing clients with a fully functional networked Laboratory ready to collect data is our goal.
Installation, integration and Customization (including Network Infrastructure and Platforms)
Documentation – SDLC, SOPs, and Training
Global System Deployments
Providing SME Guidance and support for initial implementations, remediation, and system upgrades
Delivering a successful project on time and within budget
Providing the proper resources (Lab Informatics SME, Project Manager, Business Analysts, and Validation Engineers)
Data Migration Strategies
Master Data Migration
Retirement of Legacy Systems
Informatics System Expertise
Laboratory Information Management Systems (LIMS)
Chromatography Data Acquisition Systems (CDAS)
Data Archiving Systems
Electronic Lab Notebook
Laboratory Interfaces (LIMS/ELN/CDAS/Instruments)
Particle Size Analyzers
Dissolution Apparatus (e.g. Vankel, Sotax, others)
Balances, Conductivity, pH
Completed Project Listing for LIMS Systems:
Standards and Reagents Manager
LabStation and Parsing Scripts