Pharmaceutical Commerce - July/August 2017 - 25

Legal & Regulatory
Managing employee training at the enterprise level
The case for a single enterprise-wide learning management system
By Isabelle Noblanc, VP and General Manager of UL Compliance to Performance

companies are all
trying to advance the
health and well-being
of people through their
products and services
in a way that creates
profitable and sustained
growth for their organization. However,
as these organizations grow and work to
achieve these goals, they are faced with everincreasing layers of complexity within their
business. This is especially true with the
introduction of new products, technologies,
facility expansions, emergence into new
markets, and the management of mergers
and acquisitions.
Ad d e d t o t h i s co m p l e x i t y i s t h e
challenge of investing in enterprise-wide
applications that support an expanding
manufacturing process and value chain,
as well as a myriad of other issues. This
progression creates a diverse set of needs
for their employees, suppliers, clinicians,
third parties and even customers. These
needs include compliance, development
and performance across the company.
Companies could g reatly b enefit
from the implementation of a single
enterprise-wide earning management
system. Unfortunately, what happens
more often than not is that each
department acquires and implements
their own learning management system
(LMS), due to the nature of their specific
needs and challenges. At that point, the
objective to minimize complexity and
enhance the success of positive change and
growth is handicapped due to disparate
LMS programs across the organization.
Problems arise with the lack of a cohesive
solution in place, including the right mix of
technology and knowledge to move people
and processes from the current state to a
high performing future state.
Determining the reason why a multitude
of systems end up in an organization can, at
a glance, appear simple. The growing and
evolving departments have distinct learning
and development goals, and finding a single
platform that can be customized to meet
these diverse goals has been a challenge.
Departmental goals may include:
* Hu ma n re s ou rc e s go a l s: bu i l d
u n i ve r s a l co m p e t e n c i e s a c ro s s t h e
organization, initiate skill development
programs, manage performance reviews,
help managers, and have direct reports set
goals and career advancement paths.
* Sales and marketing goals: improve
product knowledge, provide medical
research training, drive sales performance,
increase quality leads, etc.
* Corporate complia nce goa ls:
effective training to meet compliance,
proof of competency, Code of Conduct

training, anti-briber y training, antikickback awareness, HIPAA issues, satisfy
all FDA requirements (including 21 CFR
Part 11).
Given these very diverse yet missioncritical learning and development goals,
the result is various departments acquire
their own LMS that they may perceive to
be helpful in the short term, but actually
adds another layer of complexity that will
make solving the real challenge all the
more difficult. Having numerous, nonintegrated, learning and development
technologies in-house is actually
symptomatic, in that it exposes the lack
of a holistic enterprise-wide strategy for
learning development.
This strategy will align not only with the
overall learning and development goals,
but also with the specific environment,
people, processes and process-enabling
technologies within the organization.
Just as critical, the technology must
be sufficiently advanced to adapt to the
specific needs of each department.
Solving the GxP qualification
A significant challenge with
pharmaceutical companies often lies with
the strict data integrity requirements of US
and EU regulations. Companies are required
to ensure that anyone involved in the design
and production of the products is qualified
for their role. In addition, regulatory agencies
globally require that the workforce be
educated on GxP concepts, as well as SOPs
and work instructions based on their specific
role in the organization.
Addressing this need is typically outside
of the HR auspices and falls under Quality
Assurance. It demands an LMS that supports
the following five regulatory requirements
around GxP training and qualification:
* Audit trails: 21 CFR Part 11 requires
the "use of secure, computer-generated,
time-stamped audit trails to independently
record the date and time of operator entries
and actions that create, modify or delete
electronic records."
* Electronic signatures: According to
21 CFR Part 11, signed electronic signatures
and handwritten signatures executed to
electronic records shall be linked to their
respective electronic records to ensure that
the signatures cannot be excised, copied
or otherwise transferred to falsify an
electronic record by ordinary means.
* Securit y roles: Life sciences
organizations demand extremely tight
s e c u r i t y ro l e s s o t h a t on ly s p e c i f i c
individuals can make itemized system
ch a n ge s , su ch a s m o d i f y i n g s ys tem
configuration, updating training items,
making assignments and much more.
The LMS must provide the ability to

define very granular security roles based
on different functions they will need as
managers, trainers and IT personnel, so
that managers can only see qualifications
of their direct reports.
* Role-based assignments: the LMS
must support the creation of role-based
groups and assignments to these groups.
This greatly reduces the reliance on manual
and administrative reviews to determine
which personnel are qualified for a specific
job function. Role-based functionality also
leads to more successful audit answers when
job qualifications are raised. And managers
also gain visibility into qualifications for
resource planning purposes.
* Integration with key GxP systems:
The LMS needs to support SOP version
control, for example, so that the QA team
can successfully "up version" an SOP in
the document management system (DMS)
so that a new training item is created
automatically in the LMS.
Balancing training programs
FDA has some clear expectations for
training. For instance, they require that
each employee receives the appropriate
education, training and experience (21
CFR 211.25) in the operations the person
performs. In order to ensure this is
happening, the company should establish
procedures for identifying training needs
and assuring all personnel are adequately
trained to perform responsibilities. The
responsibility is not only on the shoulders of
the learners, however. The trainers should be
qualified. One of the fundamental elements
of a training program is that the training
not be a once-and-done event, it should be
conducted on a continuing basis to ensure
employees remained trained and are up to
speed on new or revised regulations and
procedures. Furthermore, all of this needs to
be documented in an air-tight, audit-proof
format. That is where a single-enterprise
LMS shows its true value. This way, all
departments can use one system, regardless
of whether they are required to follow the
higher-level regulatory requirements or the
company's own guidelines.
To ensure technology adoption and
requirements are properly met, companies
should have a strategic road-mapping plan
in place, establish a governance system, and
have a departmental development goalsetting initiative. These will help ensure
technology adoption and requirements
are met properly across the board. HR will
develop goals to measure performance and
provide career advancement opportunities
to ensure employee retention and employee
engagement. At the same time, their goals
will capture the department's need to
provide and measure "technical skills," and
to improve an individual's competency

ratings. Quality Assurance will need to track
a role-based qualification matrix, as these
records are scrutinized by FDA and other
global regulatory bodies during inspections.
The enterprise-wide learning system
should provide an adaptive user experience
that supports "universal" competency
programs and performance management
programs that HR can deliver to employees.
Such a solution provides many benefits:
* A si ng le log i n ex per ienc e that
provides a positive learning and
development experience for all employees
a n d co n t r a c to r s . Co m p a ny c u l t u re
contributes to the identity and pervasive
values of and within an organization. For
example, if setting and meeting goals is
inherent to the culture, both management
a n d e m p l oye e s w i l l h ave a n a t u r a l
inclination toward setting and meeting
goals. Training is something that should
qualify as a critical element of company
culture and one login to one program that
approaches training in the same way across
the company will help create a consistent
and cohesive vision for the organization.
* Each department gains the
functionality they need to accomplish
their goals. People learn in different ways;
one popular theory, called the VARK
model, identifies four primary types of
learners: visual, auditory, reading/writing,
and kinesthetic. An LMS that follows
best practices will enable each of these
principles. Not only will each department
have the flexibility to provide the training
that is specifically needed to meet their
goals, standards and regulations, but it will
provide each individual a way to receive
training in an effective format.
* Corporate HR and talent executives
gain a single, powerful view into an
individual's readiness ratings, comparative
profiles, potential and overall performance
over time. The adage, "What gets measured
gets managed" has significant meaning
when it comes to learning. By being able
to track quantitative and qualitative
measurements across the enterprise, the
company can better know where the red
flags are and where they need to improve.
* Companies can reduce their
investment in multiple learning
management systems, and reduce IT effort
to deploy these systems. Companies are
seeking to improve efficiency and reduce
redundancy. Having a single LMS system
brings efficiencies that supporting multiple
systems could never provide.
* Integration with critical systems
such as MES, DMS, ERP and HRIS is
managed more efficiently. Integrating
these other enterprise systems with an
LMS multiplies the effectiveness and
reporting power of all systems. When a
continued on page 26

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Pharmaceutical Commerce - July/August 2017 - Cover4