FSD Lims Sap Part3

resources Logistics Finance and
controlling
Enterprise asset
management
Enterprise Quality Management
1 CAPA = correction and preventive action
2 COA = certificate of analysis
3 SPC = statistical process control
8
By applying quality management functionality with SAP ERP,
you are able to cover virtually all the functions of a traditional
LIMS. Moreover, it supports processes in various types of laboratories,
including industrial and commercial, adapting efficiently
to the particular needs of each distinct laboratory process. In
today’s global companies, a single laboratory can act as both a
commercial and an industrial laboratory.
An industrial laboratory is an organization within a company
that focuses on analyzing raw materials, semifinished products,
or products that are manufactured or processed by the company.
It is a fixed element of the company’s supply chain and supports
other organizational units in the same company. Expenses for
industrial laboratories are generally settled internally.
In contrast, a commercial laboratory acts as an independent service
provider for both internal and external customers. Inspection
specifications and methods can vary. Services and expenses
for commercial laboratories are generally invoiced externally.
Supporting the Industrial Laboratory
The primary focus of an industrial laboratory is to ensure the
quality of products produced by the company. It is typically
involved in the entire product life cycle, from the inspection of
incoming raw materials, to in-process and post-process control
in production, to batch determination, and finally, to issuing certificates
of analysis in sales and distribution. In an industrial laboratory,
systems must support master-data maintenance and
inspection planning, particularly the maintenance of specifications,
methods, and inspection characteristics.
With isolated LIMS, you must maintain inspection plans and
specifications separately in various individual systems. In an integrated
system, you maintain master data in one location. Additionally,
you can integrate problem management into all processes.
This makes it possible for quality managers to use
workflow functions to easily notify the appropriate processor if
results are “out of spec,” and to automatically execute follow-up
actions.
The integrated approach of SAP ERP can help industrial laboratories
in the following key processes:
• Stability studies
Shelf-life studies provide a means of testing and evaluating
products during various stages of the product life cycle. This
process determines how a product will hold up under controlled
environmental conditions over predefined periods of
time.
• Incoming inspections
When procuring raw materials, it is vital for purchasing
departments to select vendors that have received a positive
evaluation in terms of price, reliability, and quality. With the
quality management functionality of SAP ERP, the purchasing
department can issue technical delivery terms or quality assurance
agreements on the purchase order and automatically initiate
inspections when goods are received. After a sample has
been drawn and the inspection completed, the company can
decide how to proceed. Goods can be released, blocked for the
rest of the production process, or sent back to the vendor with
a complaint. If there are problems, the application can notify
the logistics group directly and block the processing of purchase
orders and invoice receipts for the vendor in question.
The application can also assist in inventory management
efforts by separating the inspected goods according to the
usage decision (options include unrestricted-use stock, stock in
quality inspection, blocked stock, and return delivery).
• Inspections during production
The application can automatically trigger an inspection (inprocess
control) when a production order is released. In this
case, control charts can be used for SPC, and test equipment
can be linked to the application. Inspection activities (time)
and quantities (yield, scrap, and rework) can be confirmed
when recording the results to calculate production costs. If
required, another inspection can be triggered at the end of the
production process. For these inspections, the application can
support legal requirements, such as the Good Manufacturing
SAP ERP IN THE LABORATORY
9
Practice (GMP) data security requirements (see the “GxP
Requirements and 21 Code of Federal Regulations Part 11
Compliance” section below), or multilevel release. Digital signatures
can be added when drawing samples, recording results,
or when deciding whether to use incoming goods or produced
batches. Batches can be classified according to the inspection
results.

FSD Lims Sap Part3

Uploaded by

Copyright:

Available Formats

FSD Lims Sap Part3

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

FSD Lims Sap Part3

Uploaded by

Copyright:

Available Formats

resources Logistics Finance and

You might also like