Delivering high quality
software in a Pharmaceutical
environment can be a steep
challenge. The demands of
meeting tight delivery
schedules, ensuring quality
implementation of complex
business rules, and Part 11
compliance often make
on-time delivery a
formidable goal. In
addition, an ongoing trend
toward industry
consolidation has created
the need to integrate
diverse validated systems,
so that legacy and new
development interoperate
seamlessly.
RTTS has broad experience
working on validated
Clinical, Safety Data and
Discovery systems. RTTS
engineers and software
quality assurance analysts
are trained in Part 11
compliance, and are
experienced in documentation
procedures, traceability
practices, and IQ/OQ/PQ
procedures. We have produced
a full range of reporting
for signoff, including Test
Plans, Test Cases, Test
Cycle Summaries, as well as
the accompanying
implementation work.
RTTS has the demonstrated
experience to ensure the
quality, scalability and
compliance of the broad
range of complex systems
critical to the
Pharmaceutical business.
Technologies supported:
- Java
- .NET
- Web
- SOA Web services (SOAP,
XML)
- Grid computing
- Database: Oracle,
Sybase, SQL Server, DB2
- IBM MQ, MSMQ
Experience:
RTTS teams have executed
software QA projects on:
- Safety Data - Data
warehouse
- Automated data
verification between
source and Data
warehouse databases
- Automated data
verification between
Data warehouse and
Data Mart databases
- Automated data
verification between
Data Mart and
reporting tool
- Automated
verification of
hundreds of GB of
data
- Performance
testing of reporting
tools
- Clinical
Study-related systems
- Custom automated
regression testing
of systems tracking
- Study
outcomes
- Budget
and activity
tracking
- Audit
tracking
- Submission
documents
- Performance
testing of Clinical
Study software tools
- Drug
Discovery-related
systems, including
- Laboratory
animal management
systems
- LIMS systems
- Pharmacokinetic
data management
systems
- Organ Weights
Analysis Systems
- Toxicology data
management Systems
Testing Approaches:
- Manual functional
testing
- Automated functional
testing
- Data feed and report
validation (XML, TXT,
HTML, XLS)
- SOA Web services
validation
- Database validation
- End-to-end
transaction testing,
verifying the data flow
through disparate
applications, databases,
web services, feeds and
reports
- Complete data
lifecycle testing, from
data entry, through
processing and reporting
- Messaging layer
testing (IBM MQ, MSMQ)
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