Quality Systems Development

Neptune and Company, Inc. has developed quality management systems for a number of clients, including:

  • The U.S. Environmental Protection Agency's (EPA's) Office of Environmental Information, which provides a wide range of services in the areas of information management and technology.
  • The chemistry manufacturing and controls (CMC) review process at the Food and Drug Administration. The CMC review is a key step in the evaluation and approval for manufacturing of new drugs and biologics.
  • The EPA Special Pathogens Analysis Laboratory (SPAL) program plan for laboratory operations and environmental analysis of bioterrorism agents such as anthrax (Bacillus anthracis). The program plan included a quality system and standard operating procedures for sample tracking, sample analyses, and general SPAL operations.

We have played a lead role in the creation of several EPA guidance documents, including:

  • Guidance on Data Quality Indicators;
  • Guidance on Data Verification and Data Validation;
  • Guidance Document for Environmental Technology Design, Construction, and Operation; and,
  • Guidance on Systematic Planning for Environmental Data Collection Using Performance and Acceptance Criteria.

We have also prepared and conducted training workshops for national audiences on technical issues related to environmental QA and statistics. We have made training presentations at EPA’s annual National Conference on Managing Environmental Quality Systems and at EPA’s annual Summer Training Workshop. Neptune and Company, Inc. has quality system development experience at both the program and project level.