Chapter 11: FDA Unique Device Identification Verification and Validation
164 Regulatory Affairs Professionals Society (RAPS)
code must be entered. These codes are available
from the GMDN Agency, either for free (up to
50 terms available under a basic license) or as
part of a paid membership license (which offers a
number of other benefits). A word of caution: As
the GMDN agency continually adds and updates
these codes, companies submitting data via
HL7 SPL will need to subscribe to the GMDN
Agency to gain access to these codes.7
Does V&V Need to be Planned During UDI
Implementation?
Whether or not to include verification or
validation in implementation planning is not a
choice. At least one—preferably both—must be
performed. V&V should be conducted at key
implementation process points, e.g., during data
compilation for GUDID submission, and for
complaint-handling software, labeling soft-
ware, and software for uploading DI records
to GUDID. V&V’s purpose is to determine
whether the process is being implemented and
functioning as expected. They should be included
in the implementation plan as milestones. The
responsible person(s) for each of these V&V
milestones should sign off once a milestone has
been achieved.1,3
Many more UDI rule facets will need to be
understood to have any chance of a successful
implementation. Companies often underestimate
the time and resources needed for implement-
ing and managing UDI. The more products a
company has across multiple classes, the more
resources will be needed adding multiple sites
increases the potential for not meeting com-
pliance dates. A strong and knowledgeable
implementation team is required to overcome the
potential UDI implementation obstacles across
a complex multisite organization. Figure 11-1
shows organization departments that should
actively participate in UDI implementation.
Critical to successful UDI implementation is
early buy-in from top management on UDI’s
importance to the organization. The organiza-
tion’s top management and all employees must
Figure 11-1. Organizational Involvement in UDI Implementation
ERP System
MDM, Programs
Manufacturing
Labels, DM
Service
(If appropriate)
Finance
Budgets,
Appropriations
Document
Control
SOP Revisions,
Spec Changes
Regulatory
Regulatory
Data, Review/
Verify Data,
Submit to
GUDID
Product
Development
DHF, Labels, DM
Supply Chain
Inventory,
Suppliers
Marketing &
Sales
Sales Orders,
Literature
Suppliers Customers
Distributors
UDI Implementation
Process
Top Management
Gap Analysis
Strategic Plan
164 Regulatory Affairs Professionals Society (RAPS)
code must be entered. These codes are available
from the GMDN Agency, either for free (up to
50 terms available under a basic license) or as
part of a paid membership license (which offers a
number of other benefits). A word of caution: As
the GMDN agency continually adds and updates
these codes, companies submitting data via
HL7 SPL will need to subscribe to the GMDN
Agency to gain access to these codes.7
Does V&V Need to be Planned During UDI
Implementation?
Whether or not to include verification or
validation in implementation planning is not a
choice. At least one—preferably both—must be
performed. V&V should be conducted at key
implementation process points, e.g., during data
compilation for GUDID submission, and for
complaint-handling software, labeling soft-
ware, and software for uploading DI records
to GUDID. V&V’s purpose is to determine
whether the process is being implemented and
functioning as expected. They should be included
in the implementation plan as milestones. The
responsible person(s) for each of these V&V
milestones should sign off once a milestone has
been achieved.1,3
Many more UDI rule facets will need to be
understood to have any chance of a successful
implementation. Companies often underestimate
the time and resources needed for implement-
ing and managing UDI. The more products a
company has across multiple classes, the more
resources will be needed adding multiple sites
increases the potential for not meeting com-
pliance dates. A strong and knowledgeable
implementation team is required to overcome the
potential UDI implementation obstacles across
a complex multisite organization. Figure 11-1
shows organization departments that should
actively participate in UDI implementation.
Critical to successful UDI implementation is
early buy-in from top management on UDI’s
importance to the organization. The organiza-
tion’s top management and all employees must
Figure 11-1. Organizational Involvement in UDI Implementation
ERP System
MDM, Programs
Manufacturing
Labels, DM
Service
(If appropriate)
Finance
Budgets,
Appropriations
Document
Control
SOP Revisions,
Spec Changes
Regulatory
Regulatory
Data, Review/
Verify Data,
Submit to
GUDID
Product
Development
DHF, Labels, DM
Supply Chain
Inventory,
Suppliers
Marketing &
Sales
Sales Orders,
Literature
Suppliers Customers
Distributors
UDI Implementation
Process
Top Management
Gap Analysis
Strategic Plan