Laboratory Informatics

Covex Laboratory Informatics Consulting Services

Specialized knowledge and expertise in Information Technology, Quality Assurance and Laboratory Practices is required to successfully implement and maintain Laboratory Informatics projects and 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 2 highly trained professionals with over 30 years of laboratory informatics and validation experience combined.

Covex staff experience includes:

Project Execution

Providing SME Guidance and support for initial implementations, remediation, and system upgrades
Providing the proper resources (Lab Informatics SME, Project Manager, Business Analysts, and Validation Engineers)
Delivering a successful project on time and within budget

Implementation

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

Data Management

Data Migration Strategies
Master Data Migration
Retirement of Legacy Systems

System Expertise

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

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