In the U.S., pharmaceutical firms must meet electronic record-keeping regulations set by the Food and Drug Administration (FDA). The regulation is Title 21 CFR Part 11, commonly known as Part 11.
Part 11 requires regulated firms to implement controls for software and systems involved in processing many forms of data as part of business operations and product development.
Enterprise data warehouses are used by the pharmaceutical and medical device industries for storing data covered by Part 11. QuerySurge, the only test tool designed specifically for automating the testing of data warehouses and the ETL process, is the market leader in testing data warehouses used by Part 11-governed companies.
For more on QuerySurge and Pharma, please visit
http://www.querysurge.com/solutions/pharmaceutical-industry
2. built by
The average organization loses $8.2 million annually
through poor Data Quality.
- Gartner
46% of companies cite Data Quality as a barrier
for adopting Business Intelligence products.
- InformationWeek
The cost per patient data of Phase 3 clinical studies of
new pharmaceuticals exceeds $26,000.
- Journal of Clinical Research Best Practices
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QuerySurgeâ˘
4. Pharmaâs Largest Data Warehouse Concerns
(1) Data Integrity (2) Compliance
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QuerySurgeâ˘
5. (1) Data Integrity
high risk of defects that are not readily visible
Missing Data
Truncation of Data
Data Type Mismatch
Null Translation errors
Incorrect Type Translation
Misplaced Data
Extra Records
Transformation Logic Errors/Holes
Simple/Small Errors
Sequence Generator errors
Undocumented Requirements
Not Enough Records
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Pharmaâs Data Warehouse Concerns
QuerySurgeâ˘
6. Pharmaâs Data Warehouse Concerns
(2) Compliance
Need to comply with Part 11 mandates
historical test information test version history
test execution data:
who, what & when
test cycle information
visibility of assets archived test results
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QuerySurgeâ˘
7. Why is this Important?
ď Periodic data reporting to FDA
ď Periodic data reporting to intâl
bodies
(1) Data Integrity (2) Compliance
ď FDA announced audits
ď Unannounced FDA audits
Consequences
Severe financial and
business
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QuerySurgeâ˘
9. ď automate the manual testing of data
ď compare millions of rows of data quickly
ď flag mismatches and inconsistencies in data sets
ď provide flexibility in scheduling test runs
ď generate informative reports that can easily be shared
with the team
ď validate up to 100% of all of all data, mitigating the risk
Data Integrity needs
Need a testing solution that canâŚ
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QuerySurgeâ˘
10. Part 11 Reporting needs
ď track test history
ď provide reporting on test version history
ď record all test execution by testing ownerâs name
and date
ď deliver auditable reports of test cycles
ď store all test outcomes and test data
ď offer a read-only user for reviewing test assets
ď support archiving of results
Need a testing solution that canâŚ
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QuerySurgeâ˘
12. What is QuerySurge�
the collaborative
Data Testing solution that
finds bad data & provides
a holistic view of your
dataâs health
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QuerySurgeâ˘
13. ⢠Reduce your costs & risks
⢠Improve your data quality
⢠Accelerate your testing cycles
⢠Share information with your team
with QuerySurge⢠you can:
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QuerySurgeâ˘
⢠Provides huge ROI (i.e. 1,300%)*
*based on clientâs calculation of Return on Investment
14. Finding Bad Data
SQL
HQL
SQL
HQL
SQL
SQL
ď QS pulls data from data sources
ď QS pulls data from target data store
ď QS compares data quickly
ď QS generates reports, audit trails
How?
Reports, Data Health Dashboard
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QuerySurgeâ˘
16. Collaboration
Testers
- functional testing
- regression testing
- result analysis
Developers / DBAs
- unit testing
- result analysis
Data Analysts
- review, analyze data
- verify mapping failures
Operations teams
- monitoring
- result analysis
Managers
- oversight
- result analysis
Share information on the
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QuerySurgeâ˘
17. the QuerySurge advantage
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QuerySurgeâ˘
Automate the entire testing cycle
ď Automate kickoff, tests, comparison, auto-emailed results
Create Tests easily with no SQL programming
ď ensures minimal time & effort to create tests / obtain results
Test across different platforms
ď data warehouse, Hadoop, NoSQL, database, flat file, XML
Collaborate with team
ď Data Health dashboard, shared tests & auto-emailed reports
Verify more data & do it quickly
ď verifies up to 100% of all data up to 1,000 x faster
Integrate for Continuous Delivery
ď Integrates with most Build, ETL & QA management software
19. Fast and Easy.
No programming needed.
built by
QuerySurgeâ˘
QuerySurge⢠Modules
Compare by Table, Column & Row
⢠Perform 80% of all data tests
â˘Automatically generates SQL code
⢠Opens up testing to novice & non-
technical team members
⢠Speeds up testing for skilled SQL coders
⢠provides a huge Return-On-Investment
20. built by
QuerySurgeâ˘
QuerySurge⢠Modules
3 Types of Data Comparison Wizards:
The also provide you with automated features for:
o filtering (âWhereâ clause) and
o sorting (âOrder Byâ clause)
Column-Level Comparison:
This is great for Big Data stores and Data Warehouses where tables will have some columns
containing transformations and some columns with no transformations. Many tables and
columns can be compared simultaneously and quickly.
Table-Level Comparison:
This comparator is great for Data Migrations and Database Upgrades with no
transformations at all. Many tables can be compared simultaneously and quickly.
Row Count Comparison:
Great for all - Big Data stores, Data Warehouses, Data Migrations and Database Upgrades.
Many tables and rows can be compared simultaneously and quickly.
21. Design Library
ď Create custom Query Pairs (source & target SQLs)
ď Great for team members skilled with SQL
QuerySurge⢠Modules
Scheduling
ď Build groups of Query Pairs
ď Schedule Test Runs for:
⢠immediately
⢠at a specific date/time
⢠automatically after build or
ETL process
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QuerySurgeâ˘
22. Deep-Dive Reporting
ď Examine and automatically
email test results
Run Dashboard
ď View real-time execution
ď Analyze real-time results
QuerySurge⢠Modules
built by
QuerySurgeâ˘
23. built by
QuerySurgeâ˘
⢠view data reliability & pass rate
⢠add, move, filter, zoom-in on any data
widget & underlying data
⢠verify build success or failure
24. Test Management Connectors
built by
QuerySurgeâ˘
ďź Drive QuerySurge execution from your Test Management Solution
ďź Outcome results (Pass/Fail/etc.) are returned from QuerySurge to your Test Management Solution
ďź Results are linked in your Test Management Solution so that you can click directly into detailed QuerySurge
results
⢠HP ALM (Quality Center)
⢠Microsoft Team Foundation Server
⢠IBM Rational Quality Manager
Integration with leading
Test Management Solutions
26. Case Study: Fortune 500 Pharma
Challenge
How can a Data Warehouse team assure data
integrity over multiple builds when the cost per patient
data of Phase 3 clinical studies exceeds $26,000 and
volume of live case data is > 1 TB?
Strategy
Implement QuerySurge⢠to dramatically increase
coverage of data that is verified for each build.
Implementation
⢠1,000 SQL queries written to compare case data from
the source systems to the DWH after ETL.
⢠QuerySurgeâ˘automated the scheduling, test runs,
comparisons and reporting for each build.
built by
QuerySurgeâ˘
27. Metrics
ďź 500 mappings
ďź 2.5 million data items
ďź 1.25 billion verifications
ďź Complete run finished in 7 days
ďź 45% of data was covered.
ďź 14 builds were deployed
ďź 115 defects were discovered and
remediated
Case Study: Fortune 500 Pharma
Benefits
⢠10-fold increase in the speed of testing.
⢠Huge increase in coverage of data (from less than 1/10 % to 45%)
⢠Production defects discovered that were missed in previous cycles
⢠Huge savings on clean records (115 defects x $26,000/record)
⢠A huge time savings (3.6 years x 10 people)
⢠Avoidance of lawsuits and FDA fines
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QuerySurgeâ˘
28. (1) a Trial in the Cloud of QuerySurge, including self-learning
tutorial that works with sample data for 3 days or
(2) a Downloaded Trial of QuerySurge, including self-learning
tutorial with sample data or your data for 15 days or
(3) a Proof of Concept of QuerySurge, including a kickoff &
setup meeting and weekly meetings with our team of experts
for 30 days
http://www.querysurge.com/compare-trial-optionsfor more information, Go here
TRIAL
IN THE CLOUD
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QuerySurgeâ˘
Free Trials
Other Pharmaceutical Industry Complexities
------------------------------------------------------------------------
Industry consolidation causing massive integration of data
FDA CFR Part 11 compliance
A broad variety of data types and sources may be fed into a data warehouse.
general Pharma-specific information exchange formats (e.g., HL7 feeds, CDISC feeds, other XML grammars)
multiple proprietary and internal data formats, which may have been acquired in the process of industry consolidation.
QuerySurge can automate the comparison of all data from source files and databases through different legs of the ETL process to the target data warehouse.
QuerySurge can be scheduled to run immediately, next Monday at 11:00pm or when an event, such as the current ETL process ends.
QuerySurge will execute tests that automate the comparison of target data to source data very quickly, comparing millions of rows of data in minutes.
On completion of the run, QuerySurge will produce informative summary and detailed reports that can be viewed immediately or shared with the team via the automated email scheduler.
QuerySurge will validate 100% of all of your data, providing full coverage and mitigating the risk while providing reports highlighting every data difference, down to the individual character.
- tracks test history (user, date, each test version)
- provides reporting on test version history for convenient auditing
- supports tracking of deviations from approved tests
- records all test execution owners by name and date
- delivers auditable results reporting of test cycles
- stores all test outcomes and test data for post-facto review or audit
- offers a read-only user type for reviewing test assets
- supports off-database archiving of results (for future restore) for effective long-term results data management
QuerySurge provides insight into the health of your data throughout your organization through BI dashboards and reporting at your fingertips. It is a collaborative tool that allows for distributed use of the tool throughout your organization and provides for a sharable, holistic view of your dataâs health and your organizationâs level of maturity of your data management.
QuerySurge helps your team coordinate your data quality initiatives while speeding up your development and testing cycles and finding your bad data. Why risk having your team identify trends and develop strategic initiatives when the underlying data is incorrect? QuerySurge reduces this risk.
QuerySurge finds bad data by natively connecting to:
any data source, whether it is any type of database, flat file or xml and
can connect to any data target, whether it is a db, file, xml, data warehouse or hadoop implementation.
QuerySurge pulls data from the source and the target and compares them very quickly (typically in a few minutes) and then produces reports that show every data difference, even if there are millions of rows and hundreds of columns in the test. These reports can be automatically emailed to your team.
You can pick from a multitude of reports or export the results so that you can build your own reports.
Your distributed team from around the world can use any of these web browsers: Internet Explorer, Chrome, Firefox and Safari.
Installs on operating systems: Windows & Linux.
QS connects to any JDBC-compliant data source. Even if it is not listed here.
QuerySurge can utilized by active practitioners such as testers & developers to create and launch tests, or by managers, analysts and operations to view data test results and the overall health of the data. QuerySurge facilitates this by providing 2 types of licenses: (1) full user & (2) participant user.
(1) Full User â This type of user has unlimited access to create QueryPairs, Suites, and Scenarios. This user can also schedule and run tests, see results, run and export reports, and export data. Perfect for anyone creating and/or running data tests while performing analysis of results.
(2) Participant User â This user cannot create or run tests, but has access to all other information - including viewing all query pairs, results, and reports, receiving email notifications, and exporting test results and reports. Perfect for managers, analysts, architects, DBAs, developers, and operations users who need to know the health of their data.