Solutions

Lab Systems & Informatics

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.

Staff experience includes:

Implementation

  • Installation, integration and Customization (including Network Infrastructure and Platforms)
  • Documentation – SDLC, SOPs, and Training
  • Global System Deployments
  • Support/Hypercare

Project Execution

  • 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 Management

  • Data Migration Strategies
  • Master Data Migration
  • Retirement of Legacy Systems

Informatic System Expertise

  • Laboratory Information Management Systems (LIMS)
  • Chromatography Data Acquisition Systems (CDAS)
  • Data Archiving Systems
  • Electronic Lab Notebook
  • Laboratory Interfaces (LIMS/ELN/CDAS/Instruments)

Laboratory Validation

  • Analytical Instruments
  • Electronic Notebooks
  • Laboratory Automation

Successfully completed project listing for the following LIMS Systems:

Labware

  • Lot Manager
  • Batch Manager
  • Stability Manager
  • Environmental Monitoring
  • Project Manager
  • Standards and Reagents Manager
  • Inventory Manager
  • Changes Manager
  • Investigation Manager
  • LabStation and Parsing Scripts
  • LIMSBasic
  • Empower Interface
  • Electronic Signatures
  • SAP Interface

SQL*LIMS

  • SQL*QA
  • SQL*Stability
  • SQL*Protocol

Expertise in the following Instrumentation:

  • HPLC
  • UPLC
  • Gas Chromatography
  • UV Vis
  • FTIR
  • Karl Fisher
  • Density Meters
  • TOC
  • Particle Size Analyzers
  • Autosamplers
  • Atomic Absorption
  • Polarimeter
  • Dissolution Apparatus (e.g. Vankel, Sotax, others)
  • Balances, Conductivity, pH

For more information about Verista’s COMPUTER SYSTEM VALIDATION, contact us here or call 317.849.0330 today for a free, no-obligation risk assessment.