GAMP 5 - Good Automated Manufacturing Practice
Chapter 8: Efficiency improvements – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 8.6: Employing a Well-Managed Handover Process

What does 8.6 require?

The project team's transfer of the system to its process and system owners and the operational users is planned to agreed criteria as a prerequisite for maintaining compliance in operation, considering maintenance support requirements, outstanding problems, how long the business can be stopped, rollback capability, non-optional updates such as those pushed to SaaS applications, the information and updated procedures required at handover, training needs, communication with support and help desk groups, the change control process during a phased handover, responsibilities for accepting the system and assessing outstanding problems, a possible hypercare period, and the preservation of implicit as well as explicit knowledge through expert lists and lessons learned.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ISO 13485:2016 · 1 control

  • 7.3.8 Design and development transfer

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Chapter 8: Efficiency improvements – GAMP 5 - Good Automated Manufacturing Practice

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.