The Medical Device Validation Handbook
165
understand that a failed implementation has the
potential to stop sales in their tracks.
Companies should incorporate three
steps—planning, implementation, and fol-
low-through—to be compliant with UDI
requirements. V&V is a significant component
to implementing UDI. Throughout the planning,
implementation, and post-implementation pro-
cesses, companies need to build in and document
their V&V activities to show the FDA that they
are using valid data and processes to control their
master data and UDI labeling.
UDI Implementation Process:
Examine, Strategize, and Prepare Plan
Medical device labelers should establish an
implementation team to plan for required system
changes. Labelers need to develop strategic plans
and schedules (details, budgets, assignments,
partners, etc.) to:
• Perform gap analysis on data required for
GUDID submission, software systems,
labeling processes and equipment, SOPs,
supply chains, and more
• Address needed product lifecycle manage-
ment (PLM) changes, enterprise resource
planning (ERP) and supply chain systems,
labeling and packaging equipment and pro-
cedures, and labels and packaging
• Define GUDID gateway
• Create V&V and compliance plans of action
• Determine how master data will be accu-
rately maintained going forward
• Determine whether 21 CFR Part 118 revali-
dation will be required
• Identify software programs that need
changing (complaint handling, label printing,
electronic device history record (DHR), etc.)
• Determine which existing SOPs need to be
updated to meet UDI requirements and
• Identify and verify the correct GMDN
Preferred Term for each DI record.
During this UDI implementation phase, a
critical aspect is identifying all the tasks that will
need to be verified and/or validated. Process vali-
dation and software validation are the tools used
during UDI implementation. Process validation
will be used for data gathering for GUDID
submission. Software validation will be used for
changes made to complaint-handling software,
labeling software, software for uploading DI
records to GUDID, electronic DHR systems,
and labeling inspection devices and/or software
(see below for more information).
The FDA’s QSR at 21 CFR Part 820.75(a)
establishes the requirements for process valida-
tion: “Where the results of a process cannot be
fully verified by subsequent inspection and test,
the process shall be validated with a high degree
of assurance and approved according to estab-
lished procedures.”6
A guidance document from the Global
Harmonization Task Force (GHTF), Quality
management systems—Process validation,9 was
written primarily for medical devices. However,
this guidance’s methodologies can be used for
process V&V during UDI implementation. As is
the case in product design, an important aspect
of process design is output verification. As has
been discussed, UDI implementation requires
software and process V&V.
Data Gathering
This is one of the hardest tasks in implementing
UDI. Before starting this process, a company
should develop a Process V&V Plan (see the
FDA’s guidance, Reporting of computational
modeling studies in medical device submissions,
and the agency’s draft guidance, Technical con-
siderations for additive manufactured devices),
which details the steps to be used to gather the
required data and verify or validate their accuracy.
The written plan should include:
• Developing an educational document
to train staff on GUDID attributes and
processes to be used for data gathering,
data verification or validation, controlling
spreadsheets (if used) and designating who
will have signoff responsibilities
• Creating a repository for the gathered data
with identified columns for the required
data elements to be collected, i.e., attribute
spreadsheet
165
understand that a failed implementation has the
potential to stop sales in their tracks.
Companies should incorporate three
steps—planning, implementation, and fol-
low-through—to be compliant with UDI
requirements. V&V is a significant component
to implementing UDI. Throughout the planning,
implementation, and post-implementation pro-
cesses, companies need to build in and document
their V&V activities to show the FDA that they
are using valid data and processes to control their
master data and UDI labeling.
UDI Implementation Process:
Examine, Strategize, and Prepare Plan
Medical device labelers should establish an
implementation team to plan for required system
changes. Labelers need to develop strategic plans
and schedules (details, budgets, assignments,
partners, etc.) to:
• Perform gap analysis on data required for
GUDID submission, software systems,
labeling processes and equipment, SOPs,
supply chains, and more
• Address needed product lifecycle manage-
ment (PLM) changes, enterprise resource
planning (ERP) and supply chain systems,
labeling and packaging equipment and pro-
cedures, and labels and packaging
• Define GUDID gateway
• Create V&V and compliance plans of action
• Determine how master data will be accu-
rately maintained going forward
• Determine whether 21 CFR Part 118 revali-
dation will be required
• Identify software programs that need
changing (complaint handling, label printing,
electronic device history record (DHR), etc.)
• Determine which existing SOPs need to be
updated to meet UDI requirements and
• Identify and verify the correct GMDN
Preferred Term for each DI record.
During this UDI implementation phase, a
critical aspect is identifying all the tasks that will
need to be verified and/or validated. Process vali-
dation and software validation are the tools used
during UDI implementation. Process validation
will be used for data gathering for GUDID
submission. Software validation will be used for
changes made to complaint-handling software,
labeling software, software for uploading DI
records to GUDID, electronic DHR systems,
and labeling inspection devices and/or software
(see below for more information).
The FDA’s QSR at 21 CFR Part 820.75(a)
establishes the requirements for process valida-
tion: “Where the results of a process cannot be
fully verified by subsequent inspection and test,
the process shall be validated with a high degree
of assurance and approved according to estab-
lished procedures.”6
A guidance document from the Global
Harmonization Task Force (GHTF), Quality
management systems—Process validation,9 was
written primarily for medical devices. However,
this guidance’s methodologies can be used for
process V&V during UDI implementation. As is
the case in product design, an important aspect
of process design is output verification. As has
been discussed, UDI implementation requires
software and process V&V.
Data Gathering
This is one of the hardest tasks in implementing
UDI. Before starting this process, a company
should develop a Process V&V Plan (see the
FDA’s guidance, Reporting of computational
modeling studies in medical device submissions,
and the agency’s draft guidance, Technical con-
siderations for additive manufactured devices),
which details the steps to be used to gather the
required data and verify or validate their accuracy.
The written plan should include:
• Developing an educational document
to train staff on GUDID attributes and
processes to be used for data gathering,
data verification or validation, controlling
spreadsheets (if used) and designating who
will have signoff responsibilities
• Creating a repository for the gathered data
with identified columns for the required
data elements to be collected, i.e., attribute
spreadsheet