PLM community
Government regulations of interest
NOTE References on this page are provided as a convenient starting
point. You are solely responsible for ensuring that you are following the current
regulatory requirements affecting your organization.
Directive 2002/95/EC of the European Parliament and of the Council of 27 January
2003 on the restriction of the use of certain hazardous substances in electrical
and electronic equipment (RoHS)
Directive 2002/96/EC of the European Parliament and of the Council of 27 January
2003 on waste electrical and electronic equipment (WEEE)
UN Economic and Social Council: UN/ECE Recommendation 20:Codes for units of measure
used in international trade (15 Jan 2001)
US Food & Drug Administration: 21 CFR Part 11 "Electronic Records;
Electronic Signatures"
US Food & Drug Administration: Guidance for Industry Part 11, Electronic Records;
Electronic Signatures - Scope and Application
US Food & Drug Administration: 21 CFR Part 820 "Current good manufacturing
practice (CGMP)"
US Food & Drug Administration: Quality Systems Manual. "Section
9: Document and Change Control" specifically addresses document management.
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