Streamlining management of inStrument Qualification Documentation … · 2010-11-08 ·...
Transcript of Streamlining management of inStrument Qualification Documentation … · 2010-11-08 ·...
Streamlining management of inStrument Qualification Documentation with waterS nugeneSiS SDmS
In regulated laboratories,
analytical instruments are
required to be qualified
prior to use. Additional
requalification is recommended
on a time-based schedule, e.g.
yearly, or after a major repair.
This can add up to multiple
qualifications per instrument
per year.
The qualification process must
be documented every time, and
the generated reports must be
available for review in case of
a regulatory inspection.
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Depending on the complexity of the instrument and the scope of
tests performed, the volume of documentation produced for each
instrument qualification can be significant.
In a large company, dozens or even hundreds of instruments may be
present. For example, a laboratory with 100 instruments that each
require qualification once a year, creating 30 pages of reports each,
will result in 3,000 pages of qualification documentation every
year that needs to be filled in, reviewed and approved, stored, and
available for retrieval.
While this effort is necessary for business to continue, it does not
add any value to productivity or revenue. Viewed from a Lean Six
Sigma standpoint, it represents a potential for process optimization
and elimination of non-value added steps and waste.
emPow er SYSt emSQtWaters offers qualification projects for Empower™ and Empower 2
software, including methods for qualification of Waters, Agilent,
and other chromatography instruments and detectors.
These projects contain everything needed for running qualification
tests, calculating test results, and comparing the results to
acceptance criteria.
Figure 1. A generic, paper-based system qualification process. Qualification reports are printed to paper, manually reviewed by QA personnel, and stored in a warehouse. While still common, this adds up to huge amounts of paperwork and creates bottlenecks in timely report retrieval (e.g. during an inspection), as paper has to be retrieved, possibly from a cabinet or warehouse.
Waters® Empower SystemsQT™ enhances the Installation
Qualification (IQ), Operational Qualification (OQ), Performance
Qualification (PQ) testing, and qualification data management of your
UPLC® and HPLC systems in an Empower software environment.
The projects also include reporting methods that will generate
detailed reports for each test. All of the information – measurement
results and reports – will be stored in the Empower database and
can be reviewed there, or printed out.
A template for a Qualification Summary report is also available and
can be filled out manually. This whole system test approach offers
a more accurate indication of overall system-level compliance,
providing traceability of qualification data and allowing users to
qualify multiple systems at the same time, which simplifies the
effort of instrument qualification a great deal. All results and
reports are securely stored and available in Empower Software.
However, SystemsQT will only work for those systems supported by
Empower Software, and the Qualification Summary report will have
to be filled out manually. Also, many customers still print out the
SystemsQT reports and Qualification Summary report in order to
keep them filed on paper with the qualification documentation for
their other instrumentation.
In addition, compliance managers may not have access to Empower
Software, or they may not be adequately trained in its proper use.
wat erS nugeneSiS SDmS for Qualif icat ion DataWaters NuGenesis® SDMS easily and automatically captures
printouts from any application that can print from a PC connected to
the network. Its special printer driver will electronically capture the
printed SystemsQT reports, and store an exact likeness of them in a
secure, compliant-ready data repository.
Figure 2. Empower SystemsQT generates and stores the relevant qualification data in the Empower database. The review can be done electronically, and only the Qualification Summary report is printed on paper. This greatly reduces the time needed and amount of paper produced. Paper-based processes are still needed for instruments not supported by Empower SystemsQT.
While printing, metadata (data about data) will automatically
be extracted from the printed report, and this metadata is used
to create a document catalog. Using the web-based interface of
NuGenesis SDMS, reviewers and QA personnel can access the
SystemsQT report without needing an Empower client. Reports can
be retrieved, viewed, and electronically signed from any location
through an easy-to-use web interface.
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Completed SystemsQT projects can also be automatically archived to
SDMS, freeing up space in the Empower database. Should they need to
be reprocessed, they can easily be restored to Empower.
In the same way, NuGenesis SDMS can also capture qualification
data and reports from instruments not supported by Empower, so all
qualification data can be collected in one secure, compliant-ready
central location where it can be conveniently retrieved, even years
after its creation. Pre-configured SDMS projects with templates
for the automated cataloging of all SystemsQT data are available
out-of-the-box for a quick start. Templates for other systems can be
easily created by customers or by the Waters Enterprise Software
Services (ESS) group.
taKing it a St eP furt herUsing the NuGenesis Software Development Kit (SDK) and
Extraction Template functionality, test results can be extracted from
the reports, providing an automatically generated Qualification
Summary. This saves time, effort, and potential errors, compared to
a manual process and eliminates non-value added workflow steps.
Figure 3. Using the NuGenesis SDMS template technology and Software Development Kit (a scripting tool to automate routines), information from qualification reports can be automatically cataloged, and made easily reusable – manually or automatically.
concluSionSInstrument Qualification is a documentation-intensive process that
generates large amounts of paper reports. Using NuGenesis SDMS,
qualification documentation originating from Empower SystemsQT
and other systems with a qualification capability can be captured in
a secure, compliant-ready central repository, and easily accessed
through a web based user interface. Using scripting tools, the cre-
ation of Qualification Summary reports can be streamlined further
by automating the collation of the test results.
BenefitS of uSing nugeneSiS SDmS to manage Qualif icat ion Documentat ionn All qualification reports (even those not generated
with Empower Software) are stored electronically in
a single compliant-ready central repository to streamline
data management.
n Reviewers only need access to a web browser to review
qualification reports, thereby requiring less training to
review records.
n Quicker review of qualification reports with fast electronic
record searching.
n Electronic storage of qualification records reduces document
warehousing costs and retrieval times.
n Eliminate waste and non-value added steps in the process.
Figure 4. With NuGenesis SDMS, all Empower SystemsQT data and reports can be automatically captured into a secure, central repository that is easily accessible through a web browser. Review and signoff can be performed electronically. The same fully electronic process is also applicable to systems not supported by Empower SystemsQT, centralizing all System Qualification data and making it more easily accessible. The review and approval processes are unified and simplified, significantly reducing overhead.
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Waters, UPLC, and NuGenesis are registered trademarks of Waters Corporation. The Science of What’s Possible, Empower, and SystemsQT are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.
©2010 Waters Corporation. Produced in the U.S.A.October 2010 720003790en AG-PDF