Copyright 2003-2004
Miller Regulatory Consulting, Inc.
Last updated: 08/15/2009

 

  
  Miller Regulatory Consulting, Inc.
MRC provides an extensive selection of options to help the Life Sciences industry comply with current FDA regulations using proven, cost-effective methods.

Service options include:

  • Computer System Validation
  • 21 CFR Part 11 Services
  • Compliance Management
  • Seminars and Training

Typical engagements include: senior management training on 21 CFR Part 11 in medical device firms, compliance evaluation of quality systems, risk analysis for network infrastructures, validation of chromatography data systems for biotech and pharmaceutical companies, 2-day hands-on validation training workshops, evaluation and recommendations for user requirements, development of technical SOPs, evaluation and recommendations for system development life cycle and quality systems in instrumentation companies, supplier audits, evaluation and recommendations for regulatory compliance of validation programs in pharmaceutical firms. 

For assistance with the validation of chromatography data systems, MRC uses the WaveGenerator chromatography simulator. The WaveGenerator creates custom signals representing chromatograms and sequences for testing and training without having to create chemical samples. Contact MRC for further information.

From computer validation and Part 11 assistance to compliance management and training,
MRC offers practical and defensible solutions to your regulatory compliance needs.