SQL Sl Solution

8/3/2019 SQL Sl Solution

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SQL*LIMS

Software v4.0 Client/Server

SL Solution for R/3

Applied Biosystems, 3833 North First St., San Jose, CA 95134 408-577-2200

SQL*LIMS SL Solution Integrates SAP R/3 QM With SQL*LIMS

Applied Biosystems is a partner with SAP and has received certification of its SL Solution

implementation in August, 1997. SL Solution uses SAPs IDI (Inspection Data Interface) which

tightly couples SQL*QA and theR/3 Quality Management(QM) module. SQL*QA and SAPs

QM are complementary products. The design strategy of QM is to provide the recording of final

results of laboratory testing associated with an intermediate or final product. To deliver a

complete solution SAP is providing the QM-IDI to allow LIMS to perform the actual sample

handling and laboratory testing.

SAP R/3 QMThe QM module of SAP R/3 is developed for controlling the quality of products and production

processes. It contains comprehensive functionality for quality planning, quality inspection andquality control. Batch management is a part of R/3 QM. The QM module allows users to define

an inspection plan from which inspection lots are created. An inspection lot can be created several

ways in SAP: at Goods Receipt, Goods Issue, or Production. An inspection plan consists of a set

of operations (test methods) with one or more characteristics (results) with upper, lower, and

target limits.

The QM module uses the

following data to perform the

quality management:

Material master

Inspection Methods

Inspection Characteristics Sampling Procedures

Inspection Catalogues

An inspection plan defines what

and how many quality parameters

have to be measured.

An inspection lotis generated to

hold the characteristics (laboratory results) that are to be measured.

R/3 QM allows a usage decision to be

issued for a batch of material.

The QM module lacks the functionality ofsample management. The physical samples can be

defined in QM for an inspection lot, SL Solution provides additional tracking of sublots, sample

sources, and manufacturing stages. Providing this additional sample managementallows quality

assurance to make an informed decision when releasing products.

Applied Biosystems SL Solution for R/3Applied Biosystems SL Solution provided an unrivaled interface by combining the power of

SQL*QA and SAPs QM module. SQL*QA provides the ability to track an inspection lot. Since


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SQL*LIMS


SL Solution for R/3


QM does not have the concept of a stage, the final or certificate of analysis results are stored in a

final stage in SQL*QA. Additional stages can precede the final stage, which allows tracking of allintermediate samples generated for laboratory testing. The real advantage is that with stages, as

well as sublot tracking in SQL*QA, you can perform both in-line production corrections and

partial lot releases. Thus, you can increase your lot conformity. SQL*QA extends QMs

definition of a sample. QM handles samples as replicates of a result. The QM samples are

identified as 1, 2, 3, 4, for each characteristic. The diagram below shows how the SAP and

SQL*QA data is mapped to provide a highly efficient interface.

Inspection Lot

Operations

Characteristics( physical sample, method)

SL SAP Samples

SL SAP Tasks

SL SAP Charact.(SAP sub-samples)

SL SAP Results

SL SAP Lot

SAP Inspection Lot SL Solution for R/3

SQL*QA Stage

SL Samples

SL Tasks

SL Results

SQL*QA Lot

SQL*LIMS


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SQL*LIMS


SL Solution for R/3


SL Solution ImplementationSL Solution has implemented all 12 functions of the IDI interface including inspection points for

continuous monitoring, providing the most comprehensive LIMS interface to SAP on the market.

SL Solution is available in two forms; SL Solution Kit contains the necessary software tools and

user manuals for customers that plan to implement the SAP connection themselves; SL Solution

Plus includes the software and implementation services providing a turnkey solution.


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Summary of SAPs QM FeaturesSAPs Quality Management System, with its integration to laboratory information management

systems, links the laboratory with the production plant and enterprise - you have consistent

quality information, enterprise-wide for improved regulatory compliance. It integrates quality

management across the entire supply chain to ensure consistent product, process and service

quality.

Integrated quality management throughout the supply chain.

Comprehensive quality planning, inspection and evaluation capabilities.

Full change control .

FDA/GMP validation compliant.

Complete quality history for vendor performance analysis, problem analysis and batchtraceability.

Customer/supplier specification check.

Automatic update of vendor master data and batch.

Classification with the usage decision and quality characteristics (i.e. results).

Support of in-process and post-process quality inspection.

Integration of Process Management with Quality Management for direct entry of qualitycharacteristics and results during production using the interactive process instruction sheet.

Standard interface for integration with Laboratory Information Management Systems

(LIMS) .

Integration with process control systems for actual process data . Partial lot assignment for quantities of a production run with different quality results.

Automatic update of the electronic batch record with inspection characteristics.

Certificates of analysis.

Accurate cost analysis and cost tracking with automatic transfer of quality testing costs tocontrolling.

Comprehensive Quality Information System.


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SL Solution for R/3


SL Solutions Complimentary Features

Track individual Stages of the Manufacturing Process.

Perform Re-Samples.

Perform Re-Assays.

Receiving, Labeling or Bar-coding Samples.

Subloting.

Skip Lot Testing.

Partial Lot Release using Sublot Tracking.

Track additional information per lot, stage, sample, or task.

Assign work to specific personnel, instruments, workstations, or groups. Perform in-line corrections during the stages of manufacturing.

Enter both intermediate and final results.

Check multiple specifications in the laboratory.

Result Trend Analysis.

Instrument Interfacing.

Worklists can be automatically "triggered" to be printed at a given time or interactivelyviewed at a terminal or workstation. Worklists can be printed with barcodes for easy work

assignment and for sample verification. Supervisors can monitor analysts' Worklists.

Manual approval of results or automatic approval "triggered" by a user defined condition withmultiple levels of approval where necessary.

Status or progress tracking for lab customers with user defined security access, allowing them

to check the progress of work on selected samples. Physical tracking of a sample lets the user find the location of a sample, place the sample in a

new location, or record the disposal of the sample.

Numerous typical "generic" reports such as sample costs, sample locations, back-log reports,summary reports.

Reports can be automatically "triggered by changes in sample or result status.

The user can modify standard reports and user defined ad hoc reports easily created.

The integrated Electronic Laboratory Notebook enables the user to store user definedunlimited textual information in the LIMS database.

DATA GROUPS control access to data and allow multiple groups to use SQL*LIMSsimultaneously and totally independent of each other (e.g. QA, QC, R&D DATA GROUP,).

SQL*LIMS has a full AUDIT TRAIL that maintains a complete sample history.

GMP/GLP/GALP/IS0-9001 with TickIT CERTIFICATION ensures the enforcement ofstandard operating procedures.

Automatic decision control facilities are available such as automatically triggered reports, oruser programs at pre-defined times. This is a milestone in sample handling (e.g., logging,

result entry, approval, rejection can generate relevant reports, send memos, or run programs).

Progress tracking of lots, submissions, samples, tasks, sample location and customers.

Ability to Query on any field in the database based on solid normalized schema.

SQL Sl Solution

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