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.

2

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.

3

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.

waters corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com

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