An IQ protocol should be
written.
The IQ protocol describes how the hardware and system
and application software should be installed and should contain:
·
system description, functional
and design specifications as appropriate
·
manufacturer’s documented
recommendations for installation
·
manufacturer’s instructions for
unloading and installation
·
post-installation procedure, if
any
·
associated equipment (Note:
associated equipment should be qualified)
·
associated conditions, e.g.
environmental and ergonomic conditions
·
associated documentation and
deliverables including but not limited to:
а
List of approved deliverables
а
Manuals, operations,
administration, technical and maintenance
а
Patch notes and/or release
notes
а
Structures list (database,
fields, types, sizes, keys, links and referential relationships)
а
SOP List and SOPs (Application,
Systems, Environment, Training, IT specific and Corporate Software/Hardware
critical SOPs.)
а
Screen shots
а
File list (application, shared,
3rd party installation,
а
Module or component list
а
Media list and storage
locations
а
Report list
а
Registry changes list
а
Functional Requirements
а
User Requirements
а
Project Plans
а
Flow diagrams and/or schemas
а
User and Functional Matrixes
а
Pre-requisition descriptions
and Matrixes
а
Training procedures and
employee training records
а
Errors, dialogs and operator
interface messages
а
Audits and audit findings
·
acceptance criteria
·
responsibilities and roles
Qualification scripts may be written to support the
requirements of the protocol.
Acceptance criteria for the IQ will be documented in
the IQ Protocol and the qualification scripts, and will be based on the
functional and design specifications along with the installation
instructions. |