NuGenesis 8 Interface to SAP-QM

Bridging the documentation and workflow gap between the QC Laboratory and Business Decision Making

CONNEC T ING LABORATORY AND BUSINESS Benefits of Interfacing

Analytical quality testing is necessary and critical to the manufacture of quality, NuGenesis 8 with SAP QM
consistent products across a variety of industries including pharmaceutical, food and ■■ Workflow integration
chemical. To ensure adequate, consistent testing, regulatory agencies may require between laboratory
documentation of all safety, quality, and product identification & processing requirements. systems in QC and SAP QM
Typically, documentation in QC laboratories is largely paper-based and inefficient. ■■ SOP oversight, real-
Waters ® NuGenesis ® 8 platform easily and effectively bridges the documentation and time fit-for-use checks,
workflow gap between scientists in the QC laboratory and business managers using SAP results verification
at the operations-level. With a direct link between the NuGenesis 8 Laboratory Execution ■■ Reduction of paper
System and the SAP Quality Management (QM) system, organizations can: processes and manual
■■ Provide timely access to analytical testing results to support rapid decision making. transcription

■■ Reduce paper processes and manual transcription ■■ Comprehensive

documentation and
■■ Increase efficiency and productivity with more reliable results
data traceability
■■ Reduce opportunity for errors by minimizing manual data entry and reports generation
■■ Laboratory staff avoid
■■ Create data traceability to aid safety, regulatory filings, and legal requirements working in SAP
■■ Ability to generate
standard and customized
analytical reports

Lab Inventories
■■ Easier data sharing
and collaboration
Simple Devices ■■ Minimize waste and
variability during
quality testing
SAP-QM
■■ Faster release of
in-spec products
Instruments

SDMS
Laboratory Execution Method

Figure 1. NuGenesis 8 serves as a documentation and workflow solution for the quality laboratory –
interfacing with business systems such as SAP-QM and laboratory systems such as balances and CDS.
INT ERFACING T HE LABORATORY TO SA P-QM
NuGenesis 8 featuring Laboratory Execution (LE) technologies
encompasses NuGenesis SDMS, a compliance-ready data
repository, and NuGenesis ELN, an electronic laboratory notebook
that provides a certified interface to SAP QM. This link facilitates
seamless communication of instructions and information between
SAP-QM and the QC laboratory.
Test protocols, Standard Operating Procedures (SOPs), and
product specifications can be communicated in an accurate
and timely manner from SAP QM to the QC laboratory by
using NuGenesis 8:
■■ After a request for batch testing is received in
NuGenesis 8 from SAP-QM, NuGenesis ELN generates
protocol relevant worksheets.
■■ The NuGenesis 8 LE Technology facilitates information
exchange between systems, instrument software
(e.g. chromatography data systems), and simple devices
(e.g. balances), as well as other data management systems
■■ NuGenesis 8 maximizes QC testing by grouping tests according
to types of measurements and instrumentation usage, and
assigns specific responsibilities to laboratory personnel -
work duplication is eliminated and resources are utilized
more effectively.
■■ NuGenesis 8 performs at-the-bench results verification,
ensuring that the testing was done properly. Results are
transferred from the worksheet to SAP QM, including a
reference to the worksheet entry showing how the result
was obtained.

■■ The sample management component of NuGenesis 8

accepts sample information from SAP-QM allowing users
to view test requests status

SAP
Certificate
■ Goods Receipt
of Usage Decision
■ Production Completion
Analysis

SAP QM-IDI Interface functions

ELN/SAP Interface
Download Task Sample Upload Task
Repository

Manual Automatic
Document Creation Document Creation

ELN Record and Evaluate Results, Automated

Sign, and Approve Process

Inspection Worksheet Generate Inspection

Worksheet

Figure 2. Interface between NuGenesis 8 ELN and SAP QM--the SAP QM IDI interface is utilized to communicate with the Sample
Management repository of NuGenesis ELN to exchange business and laboratory information. The workflow starts with a Goods Receipt
and proceeds through the steps until a Certificate of Analysis is created.
VALIDAT ION, SERV IC E, AND SU P PORT
The long-term success of your use of NuGenesis 8 depends on how well you plan, deploy, and maintain your system and the degree to
which you keep your user’s knowledge and training up to date. The Waters Global Services’ Enterprise Software Solutions team provides
the programs and services you need to maintain the level of performance you expect from your Waters products. Waters offers a variety of
solutions for Service and Support, Training and Education, and Regulatory Compliance.

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