In regulated production, restoring an inspection system is only part of the task.
Changes to inspection programs, user settings or system configurations may also need to be documented, reviewed and verified according to the manufacturer’s internal procedures.
When contacting technical support, it is therefore important to tell us:
- Whether the system is used in a regulated process
- Whether validated inspection programs are affected
- Whether changes must follow a defined approval process
- Which documentation is required
- Which quality, validation or IT contacts need to be involved
Technical troubleshooting should not create an undocumented system state.
A clearly coordinated process helps ensure that the immediate technical issue and the customer’s documentation requirements are considered together.
The exact responsibilities and approval procedures remain defined by the customer’s quality system. OCTUM supports the technical analysis, implementation and documentation required for the agreed service scope.