dite redevelopment or integration of documents.
This also allows for the organization to align to
local requirements without needing to rewrite
SOPs. For a role-based model to be successful, individuals need to have their roles
recorded in the learning management
system and these roles need to be maintained as responsibilities change.
5. Ensure different document types
have clear guidelines for the different content required. It has to be
clear whether a specific document mandates process or simply provides guidance; the selected document type must also
reflect this intent. For example, policy documents set the
ambition, a quality management system (QMS) lays out the
scope, SOPs define how the scope is to be met and work instructions and other documents cover specific needs without
covering all eventualities.
6. Remember that regulatory documents should not take
the place of job descriptions and operational training; they
are there to create regulatory compliance. We often find that
many of the tasks laid out in SOPs are there to help people
do their job; they do not address regulatory need. This
means that any situation that is not completely aligned with
the way things were operationally when the SOP was written,
now run the risk of causing unnecessary compliance failure.
7. Manage all regulated documents in the same repository.
Having multiple systems or, worse, no system at all, makes
it difficult to view the entire portfolio. If documents are in
different locations then employees run the risk of not knowing where to look for the definitive version of documents. It
becomes difficult to quickly assess the impact of a change and
there is a significant risk of personally held (and therefore uncontrolled) versions being used to execute critical processes.
8. Manage local variations locally. Local organizations
are accountable for ensuring that they meet the obligations
put on them by the global organization and by their local regulator. When there is a conflict between these two
then the local wins, if there is no conflict then global takes
precedence. Trying to incorporate local requirements into
higher level documents often leads to increased complexity.
Organizations should allow local variations to be managed
locally rather than globally.
9. Ensure vital training is proportionate to the level of
involvement. If a role is central to the execution of a process
then organizations need to make sure that the right people have
received training. If, however, a role is involved only occasionally in the process, or influences only a small section of it, then
the training for that role needs to be appropriate for the level
of involvement. This requires on-demand training and training
courses that target sub-components of the process. Training
everyone on everything is neither popular nor effective.
10. Make sure that creating and deploying new docu-
mentation and processes is not a “once and done” activ-
ity. Organizations must enable the business to support
continuous improvement and monitoring of the
ABOUT THE AUTHOR
document portfolio. They must also establish
robust governance processes and infrastruc-
ture to provide effective oversight of the
portfolio and enable rigorous monitoring
to identify areas of weakness and oppor-
tunities in the portfolio.
Craig Wylie is a life sciences and
healthcare industry expert at PA
Consulting Group. You can contact him via www.pacon-
sulting.com/us. Follow PA Consulting Group on twitter
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