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:

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

Laboratory Validation

Analytical Instruments

Electronic Notebooks

Laboratory Automation

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)

Instrumentation Expertise:

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

Completed Project Listing for LIMS Systems:

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