Managing Change Control To Comply With FDA And EU RegulationsSource: MasterControl
Change control management is a key element of a quality management systems, which are used by all life science companies that must comply with the following FDA and EU requirements:
- Good Laboratory Practice (GLP, EU 1999/11/EC, 1999/12/EU, and US 21 CFR Part 58)•
- Good Clinical Practice (GCP, EU 2001/20/EC, US 21 CFR parts 50, 54, 56, 312)•
- Good Manufacturing Practice (GMP, EC Directive 2003/94/EC FOR EUROPE, 21 CFR Parts 210, 211, and 820)•
- ISO 9000 and its variants (ISO 9001: 2000, ISO 14001:2004, and ISO 13485)•
When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved. Implementation of a purpose designed, validated system for electronic change control management facilitates this process and enables organisations to achieve the potential for increased effectiveness and efficiency.