The following terms and abbreviations are commonly used throughout the industry and within this web site:

CDS - Chromatography Data System
ELN - Electronic Laboratory Notebook
LIMS - Laboratory Information Management System

EP - European Pharmacopoeia
FDA - U.S. Food and Drug Administration
GLP - Good Laboratory Practice
GMP - Good Manufacturing Practice
JP - Japanese Pharmacopoeia
NF - National Formulary
USP - United States Pharmacopoeia

IT - Information Technology
ITIL - Information Technology Infrastructure Library

IQ - Installation Qualification
OQ - Operational Qualification
PQ - Performance Qualification
UAT - User Acceptance Testing
SOP - Standard Operating Procedure
GAMP - Good Automated Manufacturing Practice
ISPE - International Society for Pharmaceutical Engineering

PMI - Project Management Institute
PMP - Project Management Professional


Following are some examples of the services we offer. Please contact us to discuss your needs.

Business Analysis 

Some of the keys to project success are a comprehensive set of requirements, and identifying the best opportunities to automate and streamline the business.

Some Business Analysis related activities:
  • Requirements definition & analysis
    • Taking into account the needs of the business, regulatory agencies, and company strategy
    • Prioritization of requirements
  • Feasibility Studies
  • Vendor Evaluations
    • Request for Proposals (RFP)
    • On-site assessment and/or pilot
  • Business and Process Analysis
  • Strategies


LIMS systems and the management of laboratory data are essential to day-to-day laboratory operations.

Some activities associated with LIMS projects:
  • Requirements gathering
    • Out of the box and custom functionality
  • Regulatory requirements (such as 21CFR Part 11)
  • System evaluation and selection
  • Identifying opportunities for process harmonization
  • Identifying and prioritizing opportunities for automation, such as
    • Instrument integration
    • Custom calculations
    • Statistical analysis
    • CDS integration
  • System configuration, such as
    • Specifications, tests, & calculations
    • Custom database tables and fields
    • Reports
  • Data migration


Chromatography systems are the heart of many analytical laboratories, and are unique in the sense that a lot of lab equipment needs to be integrated with the system, and the rollout needs to be done with minimal impact to day-to-day lab operations.

Some activities associated with Chromatography projects:
  • Requirements gathering
    • Out-of-the-box and custom functionality
    • Reports
  • Regulatory requirements (such as 21CFR Part 11)
  • System evaluation and selection
  • Identifying and prioritizing opportunities for automation, such as
    • Custom calculations
    • Statistical analysis
    • LIMS integration
  • Robust rollout and training plan

Statistical & Data Analysis 

Laboratories produce a wealth of data. How do I get to the data? How do I analyze it? Statistical & data analysis software answers these questions by providing ready access to data and automating manual data analysis.

Some activities commonly associated with Statistical and Data Analysis projects:
  • Requirements gathering
    • Pulling data from multiple systems
  • System evaluation and selection
  • Regulatory requirements (such as 21CFR Part 11)
  • Identifying and prioritizing opportunities for analysis, such as
    • Data trending
    • Process capability
    • "What If" scenarios

Project Management 

Full lifecycle project management for all major project phases, from initiation through closure.

Some typical project activities:
  • Project justification
  • Clearly identifying the scope of the project
  • Project qualitative and quantitative benefits
  • Risk identification & mitigation
  • Timing & budgets
  • Resource estimates
  • Vendor negotiation and contracts
  • Project planning & management
  • Training plans

Computer Systems Validation 

Complete range of validation documents commonly utilized in FDA-regulated environments:
  • Validation planning
  • Quality risk assessments
  • Change Control
  • Requirements
  • Design Specifications
  • Trace Matrix
  • Test Planning
  • Test Coordinator
  • Installation Qualifications (IQ)
  • Authoring / Execution of test scripts
    • Operational Qualifications (OQ)
    • Performance Qualifications (PQ)
    • User acceptance testing (UAT)
  • Validation Reports
  • Standard Operating Procedures (SOP)