Selected government regulations affecting the PLM / CM community

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 product design.

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.

PDXpert Focus
PDXpert Features
Learn More
PLM & CM Resources
Slideshow image