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21 CFR Part 11: Data Integrity and Compliance
The Journey to 21 CFR Part 11:
1991: Project launched by the U.S. Pharmaceutical Manufacturing Association
1992: First edition of EU Annex 11
1992: Advanced notice for public comment
1994: Proposed rule published
1997: Final rule published
1999: Active enforcement
1999: Computerized Systems Used in Clinical Trials (CSUCT)
2000: Electronic records
2003: “Scope and Application” guidance
2004: Draft Computerized Systems Used in Clinical Trials Guidance
2005: Notification of Japanese ERES guidelines
2006: Quality Systems Approach to Pharmaceutical cGMP Regulations
2007: Final guidance published
2007: Computerized Systems Used in Clinical Trials (CSUCT) revised
2011: Updated version of EU Annex 11 published (GLOBAL)
2016: Data Integrity and Compliance with cGMP Guidance
Beckman Coulter, Inc. All rights reserved.
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES.
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.