Services

We offer a full range of services in the areas of Project Management, Computer System Validation, and Information Technology, and have the flexibility to work with you on parts of a project, or on an entire project from start to finish.

 

Our typical IT consulting services surround laboratory automation initiatives, such as LIMS, CDS, and ELN. 

 

Project Management

Full lifecycle project management for the following major phases:

• Initiation
• Planning
• Execution
• Control
• Closure

Some typical project activities and deliverables:

• Project justification and benefits
• Project, resource, and training plans
• Management of scope, time, budget, resources, risks, issues, changes, quality, & communication

Project Management Professional (PMP) certification.

Computer System Validation

Complete range of validation documents commonly utilized in FDA-regulated environments:

• Validation Planning
• Requirements
• Design Specifications and Trace Matrix
• Installation Qualifications (IQ)
• Operational/Performance Qualifications (OQ/PQ) & test scripts
• Standard Operating Procedures (SOP)

 

Information Technology

Full range of business analysis and technical services:

• Requirements gathering
• Feasibility Studies
• Vendor Evaluations
• Business and Process Analysis
• Software Development

 

Please contact us to discuss the needs of your organization and how DMH Consulting can add to your project's success.

 

Terminology

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 Pharmacopeia

• IT - Information Technology

• IQ - Installation Qualification
• OQ - Operational Qualification
• PQ - Performance Qualification
• SOP - Standard Operating Procedure

 

• PMI - Project Management Institute
• PMP - Project Management Professional