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The quest for knowledge never ends. Here's what we've found to be useful. Let us know other resources to include and why they are significant.

One of our principals, Sanjaya Joshi, has published papers on LECIS and the biopharma community in Seattle. General resources that are always usefule include dictionaries, thesauruses and encyclopedias. Standards for life sciences and engineering cover a broad spectrum. A critical knowledge area is federal regulations governing how companies interact with individuals and patients; two examples are PDMA and HIPAA. Government agencies include federal agencies concerning health and welfare of the people, while organizations listed are non-profits and other independent bodies.


  Published Papers

 

  General Resources

 

  Standards

Laboratory

  • LECIS -- Laboratory Equipment Control Interface Standard
  • LECIS summary
  • AUTO3-A -- Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
  • AUTO5-A -- Laboratory Automation: Electromechanical Interfaces; Approved Standard

Health and Medicine

  • DICOM -- Digital Imaging and Communications in Medicine
  • HL7 -- Health Level 7
  • HRQL -- Health-related quality of life methods

Clinical Trials

  • CDISC standards -- Clinical Data Interchange Standards Consortium -- SDTM (submissions), ODM (operational), ADaM (analysis), LAB (laboratory), PRG (protocol), SEND (non-clinical), CRT-DDS (case report tabulation)
  • AnIML -- Analytical Information Markup Language

Flow Cytometry

Mass Spectometry

  Federal Regulations

CFR

Code of Federal Regulations

21 CFR Part 11

Electronic Records; Electronic Signatures

21 CFR Part 58

Good Laboratory Practice for Nonclinical Laboratory Studies

PDMA

21 CFR Part 203 -- Prescription Drug Marketing (PDMA)

  • FDA Center for Devices and Radiological Health on PDMA
  • Search for 21CFR203 on NARA CFR

GMP-- QS

21 CFR Part 820 (Quality System Regulation)
Good Manufacturing Practices (GMP) Quality System (QS)

HIPAA

Health Insurance Portability and Accountability Act

  Government Agencies

CDC

Centers for Disease Control and Prevention

DHHS

U.S. Department of Health and Human Services

EPA

U.S. Environmental Protection Agency

FDA

U.S. Food and Drug Administration

NIST

National Institute of Standards and Technology

OSHA

U.S. Department of Labor, Occupational Safety and Health Administration

  Organizations

 

     
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