Professional Documents
Culture Documents
This article
presents the
implementation
of a risk-based
approach into
a suppliers
Software
Development
Workflow
and Products
Release
Management
according to
GAMP 5.
Introduction
Figure 1. Release
management.
Reprinted from
PHARMACEUTICAL
ENGINEERING
The Official Magazine of ISPE
March/April 2009,
Vol. 29 No. 2
Copyright ISPE 2009
www.ISPE.org
Continued on page 62.
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Before
Process Engineering
After
Engineering Excellence.
Rapid Deployment
control vendors have been trying to increase their footprint
and provide functionality extending into other areas such as
LIMS and Electronic Batch Records. While a clear leader has
not yet emerged, there are dominant software product providers who have captured almost all of the enterprise business.
With that in mind, how could further software be developed that could both take advantage of an established IT
infrastructure and also could be rapidly deployed?
Let us consider one of the first operational steps in pharmaceutical manufacturing: Weighing and Dispensing. There are
many systems on the market, but they are typically standalone
solutions using their own databases. The automation aspects
are not normally challenging since integration is likely limited
to scales and possibly bar code equipment. However, integration also is required with the ERP system holding the master
product definition, Bill of Materials (BOM), and recipes.
The remainder of this article describes an approach taken
to develop weigh and dispense management software based on
the key concepts and principles described in GAMP 5, which
can be rapidly deployed by healthcare organizations while
taking advantage of existing IT infrastructure. The solution
is based on the Systems, Applications, and Products (SAP)
Manufacturing Integration and Intelligence (MII) module,
which is a tool that can be used to populate all of the SAP
transactions, and at the same time, enable business logic and
rules to be created. While MII is a tool box and does not provide
a packaged solution, it is an appropriate basis for a weighing
and dispense solution to meet the following objectives:
completely based on the ERP
no other IT infrastructure required for application and
database servers
reuse of the recipe information and order management
online communication and feedback to the ERP
one master for batch information and inventory control
online interface to the scales
ERP as the one place to hold complete batch information
(batch record)
Release Planning
The release planning phase was the initial phase of the project.
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Rapid Deployment
proach also was essential for the verification and test planning, because relevant system functions were identified and
classified on their relevance to their risk reduction factor.
The requirements analysis phase, in parallel with the risk
management activities, encompassed both the regulatory and
functional requirements of the system from the customers
perspective and the technical requirements from the developers and implementers perspective. Functional requirements
identify the expected capabilities of the system for risk reduction, capturing what the system will do without defining
how it will do it. Therefore, the Functional Specification was
written on the basis of so called Use Cases, where the real
process was transformed into a system process in terms of
sequential setup of workflows (user wizards). These technical requirements like wizard work flows, system plausibility
checks, and control functions identify the technical conditions
necessary for compliant operation of the system for the future
use within the regulated environment.
The intent of the design phase was to capture how the
requirements would be met - Figure 3. The functional and
technical requirements identified during the requirements
analysis phase were translated so that the proposed system
could be described in terms of software objects down on each
field level, such as database tables, data requirements, and
program components (i.e., windows, buttons, fields, functions,
prompts, constraints, interfaces, etc.). In addition, this level of
detail ensured a better transfer of information to the software
developers and enabled a higher level of possible software
testing in the subsequent verification processes.
For this process of requirements and testing management, the Extensible Mark-up Language (XML) was chosen,
individually customized, and used. In general, XML is a
general-purpose specification for creating custom mark-up
languages that allows its users to define their own elements.
Its primary purpose is to help information systems share
structured data and it is used both to encode documents and
to serialize data.
The test script generation for the related test phases
was automated so that any change cycles could be executed
more quickly and effectively. A correlation was maintained
between the elements of the various phase deliverables and
supporting documents; for example, the correlation between
the system requirements and functional design/specification
and the test cases that challenge them. This structured data
handling facilitates maintenance of the cross-referencing
between predicate rules, requirements, the corresponding
software elements and the test cases that challenge them,
as well as the software code.
Software Development
As a result of the risk-based functional and technical process,
the release development team started to create code. The Software Development Lifecycle (SDLC) was composed of phases
during which the software system was conceptualized, created,
implemented, and maintained. Each technical description
was logically broken down to development orders that were
assigned to individual developers. A workflow management
Continued on page 64.
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Rapid Deployment
tool handled these working packages, where pre-defined
steps, like development analysis (i.e., analysis of side impacts,
etc.), module specification, and unit testing were executed.
Also this process ensured that each development and code
generation was executed by at least two independent persons,
under control of the lead developer. Additionally, the source
code entries were referenced and managed by a source code
management tool, which also offers many more capabilities
for code generation and testing. GAMP5 references different
standards such as Capability Maturity Model Integration
(CMMI3) and ISO 122074 (software process models). Both
models give a detailed methodology and structure for software
development and should be used as guidance documents for
assessing, analyzing, and improving the current software
development workflow or to set up a new framework.
The development workflow enabled clear project control
and status, because the software development was divided into
logical working units with separate status of each development
package. After all development orders were completed, the
development phase was finalized and the first release build
was available for system testing. Release management and
a final development report for each release or build were essential for the test execution on a test environment.
During the system testing phase, verification against the
written technical specification was performed to ensure that
the use case flow, user and system interfaces, and different
configuration item settings were technically correct and in
alignment with the technical and functional requirements.
Testing was documented via organized test plans and scripts
referenced to the specifications by unique ID numbers and
a final test report of the results was produced.
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Project Implementation
The project implementation phase comprises the activities
required to coordinate the controlled and successful rollout
of the system into the clients environment and to determine
that the system fulfils the specific requirements.
Based on the fully specified and verified Standard Release
concept, a basic workflow for the project implementation can
be defined. The first and most important step is to compare
the customer requirements, normally written down in a User
Requirement Specification by the customer or optionally
within shared workshops along a prototyping concept with
the corresponding system requirements and functions of the
standard release. This Gap Analysis between customers user
and system requirements and the standard release specification determines whether:
standard release function covers the requirements
customer-specific requirements need to be realized by
configuration
customer-specific requirements need to be realized by
development or code change
Rapid Deployment
The result of the Gap Analysis is an important input into the
implementation and project setup.
Typically, about 80 to 90% of the requirements can be
covered by the standard release or by configuration of specific
configuration items. This implies that the implementation
can be managed following the approach for GAMP software
Category 4. The remainder of the functionality must follow
the approach for GAMP software Category 5, where the main
efforts of the customer can be concentrated during specification and verification.
Most specification and verification has already been completed during the software development and release stage and
the development workflow and tools are already established
during the standard release period. The customer implementation phase should follow pre-defined processes, and be based
on identified risks. The customers Validation Plan should
reference the Standard Release Quality Project Plan, and
describe how supplier documents are to be leveraged.
This approach is beneficial in terms of software quality, meeting regulatory requirements, quality risk management, process
control, and project time and costs. It also assists the supplier
with system and operations support and multi-customer relations (e.g., bug-fixing, release, and upgrade management).
Conclusion
In todays world, features and functions of software are not
the only important aspects when selecting the most suitable
and most efficient software solution. The best balance needs
to be found between the following aspects:
requirements and functional match
compatibility with a common IT solution framework and
infrastructure
implementation time
achieving and maintaining compliance with regulatory
requirements
interoperability between systems.
However, it is the end users challenge to select the right solution,
which these days is not only defined by the operating system or
database it also is influenced by the most common and dominant software solutions within the overall IT landscape. It is the
responsibility of software vendors to adopt the most appropriate
development strategies, which allows for fast deployment, seamless integration, ready-to-run configurations, and provision
of appropriate specification and verification documentation.
Benefits of the approach described in this article include:
References
1. GAMP 5: A Risk-Based Approach to Compliant GxP
Computerized Systems, International Society for Pharmaceutical Engineering (ISPE), Fifth Edition, February
2008, www.ispe.org.
2. ICH Q9-Quality Risk Management International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use, 2005.
3. CMMI for Development (CMMI-DEV), Capability Maturity
Model Integration, Technical Report CMU/SEI-2006TR-008, Software Engineering Institute, 2006.
4. ISO 12207; (ISO/IEC 12207:2008), Software Life Cycle
Processes, International Organization for Standardization,
2008.
5. Product white paper: SYPROS WDM Systec Production
Suite Weigh and Dispense Management based on SAP
MII and SAP NetWeaver platform.
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