PDXpert PLM Software
Product Lifecycle Management
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.
This application note was relevant to the PDXpert software release that was current at time of publication. Product changes since that time may affect its utility. We'd be happy to assist you in assessing the applicability of this note to your situation.