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information systems

Computer System Validation

Applying GAMP 5 and the


V-Model to Agile Development
by Eric Staib

This article will explore an alternative approach to the traditional V-Model and
how it can be applied in a more iterative software development environment.

I 
n 2008, GAMP® 5 introduced what is now a widely The Model
accepted approach to risk-based computer system Typically, the V-Model depicts the waterfall SDLC as shown
validation within the pharmaceutical and biotechnol- in GAMP® 5.2 However, as seen in Figure 1, the V-Model
ogy industries. This approach can be found throughout has been modified to present how an iterative development
the traditional System Development Life Cycle (SDLC) life cycle could look. This is pictured as a “W-Model” with
from concept, through the project phase (including an successive development and release activities throughout the
initial system assessment and requirements analysis), project phase(s).
to operation and retirement. The type of life cycle being In this manner, multiple design and module/unit speci-
considered in this article is one that includes custom fications are created and/or revised with associated unit
software development activities such as coding and unique and integration testing taking place. This cyclic activity is
configuration (GAMP Category 5 – Custom Applications). representative of an Agile iteration or sprint.3 After suc-
Although the guidance of GAMP® 5 does recognize that cessive sprints, the necessary system/functional and user
linear and/or waterfall development models are not always acceptance testing shall be conducted in order to release the
the most applicable or appropriate in all cases, the guidance system to production. In much the same manner that cod-
does still highly identify with and utilize the V-Model to ing is conducted in a very quick and concentrated manner
demonstrate and provide examples for a typical system life according to Agile development,3 so are the documented
cycle approach.1 requirements/specifications, testing and fitness for intended
In recent years, particularly in Contract Research and use being verified. In essence, the bottom of our traditional
Manufacturing Organizations (CRO/CMO), agile or iterative V-Model has become much more dynamic, flexible and fluid
development has become very much the norm in develop- to accommodate the agile approach while still maintaining
ing new and market differentiating software solutions. the robust control, discipline and documented evidence of
The needs of customers are rapidly changing and contract the V-Model. Another way to represent the W-Model is a
organizations need to be more flexible to respond to grow- “Mash Up” of the V-Model and Agile approach as seen in
ing client expectations, desires and business requirements. Figure 2.
Often these solutions evolve through close partnership and
collaboration between the customer and client, thus exploit- Risk-Based Approach
ing the benefits and strengths of Agile. However, the need to In order to make this “Mash Up” work and still do so in
remain compliant and maintain a system in a validated state an efficient and effective manner, the primary principles
can be challenging in using such a dynamic approach. This of GAMP® 5 need to be fully leveraged and in some cases,
article will explore an alternative approach to the traditional expanded to achieve a computerized system that is fit for
V-Model and how it can be applied in a more iterative soft- its intended use. For example, it must be prospectively
ware development environment. determined, or specified, as to what justification(s) shall be
used to decide upon the appropriate number of iterations

46 Supplement to PHARMACEUTICAL ENGINEERING OCTOBER 2014


information systems
Computer System Validation

Figure 1. Proposed “W-Model” (Modified V-Model) for iterative development.

that should take place prior to release. Other considerations under what circumstances? These considerations also must
may include: how will documentation be handled and/ be discussed with the process owner to determine how they
or updated? Will regression, system/functional and user will “accept” the system based upon what development test-
acceptance testing take place each time? How often, and ing (e.g., in some cases, a possible “hardening” or system

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OCTOBER 2014 Supplement to PHARMACEUTICAL ENGINEERING 47


information systems
Computer System Validation

Finally, the team members themselves


must be highly skilled, experienced and
trained individuals. They must possess
a complete understanding of both the
traditional V-Model and Agile approach,
and the combined “Mash-Up” so as to
ensure successful implementation. As
with any project, regardless of the life
cycle approach or model being followed,
team communication, personal aware-
ness, and a mutual respect for following
the process are key elements for success-
ful delivery.

References
1. ISPE GAMP® 5: A Risk-Based Ap-
proach to Compliant GxP Computer-
ized Systems, International Society for
Figure 2. V-Model and Agile approach “Mash-Up.”
Pharmaceutical Engineering (ISPE),
Fifth Edition, February 2008, Sections
stabilizing sprint4) has already been done. This should be a 3 and 4, www.ispe.org.
topic of discussion between developers and various busi-
ness unit team members during frequently held meetings. 2. ISPE GAMP® 5: A Risk-Based Approach to Compli-
Ideally, risk assessment of individual user requirements and ant GxP Computerized Systems, International Society
system functionality also should take place and be leveraged for Pharmaceutical Engineering (ISPE), Fifth Edition,
in making decisions. Once the system has been released into February 2008, Figure 4.4 – Approach for a Custom Ap-
production, the team must decide how additional sprints plication, www.ispe.org.
and development activities will take place. How will design
changes and potential impact to original requirements be 3. Balaji, S. and Sundararajan, M., “Waterfall vs. V-Model
addressed? At what point do multiple design specifications vs. Agile: A Comparative Study on SDLC,” International
and/or requirement documents get consolidated? No mat- Journal of Information Technology and Business Man-
ter what the answers to these questions may be, these basic agement, June 2012, www.jitbm.com.
principles still apply:
4. Cockburn, A., Agile Software Development (Second Edi-
• Product quality, data integrity, and patient safety must be tion), 2006.
assured.
• Fitness for intended use must be demonstrated. About the Author
Eric Staib is currently the Executive
Conclusion Director of Corporate Quality Assurance
Being able to manage a combined “Mash-Up,” as presented at PRA Health Sciences. He has 16 years
above, and still reap the benefits of each individual model of pharmaceutical industry experience
or approach is no easy task. The establishment of robust in various GXP areas, including direct
and mature configuration, change, and document manage- experience in quality systems development
ment systems must have occurred. These systems must be and management, QC microbiology, quality engineering,
efficient and effective enough to keep pace with the defined information technology, and laboratory operations. He holds
iteration and sprint cycle times determined by the project a BS from James Madison University in biology, a MS from
team. Another key element is managing the amount of detail Temple University in quality assurance and regulatory af-
specified within the URS/FS, by maintenance of stable fairs, a graduate certificate from Lehigh University in project
and high level requirements.4 This ensures that the Agile management, and a MBA from Drexel University in pharma-
development, which has essentially replaced the bottom ceutical management. Staib is also Vice Chair of the GAMP
portion of the “V,” will not be overly constrained and/or bur- North America Steering Committee, and co-chairs the R&D
dened by items that have the potential to change over time. and Clinical Systems Special Interest Group (SIG).

48 Supplement to PHARMACEUTICAL ENGINEERING OCTOBER 2014