SUCCESS
STORY
Improved quality with proper
validation of all master data
Project background
The successful collaboration between Roche and Rockwell Automation’s
Propack Data specialists has more than 10 years of history. Based on
many successful joint projects in several plants in Germany, Switzerland,
and England, Laboratoires Roche Nicholas S.A. (Roche) decided in favor
of Propack Data PMX MESTM as the most suitable solution for updating
and extending the existing manufacturing execution system (MES). This
decision was reached after an intensive evaluation phase in search for
a global MES supplier. Important factors for Roche’s decision were, e.g.,
- the completeness of Propack Data PMXTM which supports the entire
pharmaceutical life-cycle from goods receipt through the production
process to the finished product,
- the benefit of a single-source, prevalidated system, and
- the confidence in a partner offering dependable system support
following the productive start.
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Laboratoires Roche Nicholas S.A. Gaillard, France
Customer situation
The entire shop-floor level at Roche Gaillard used to be equipped with
a highly customized legacy MES. With some 10 years of age, it was
technologically obsolete and at the end of its life cycle. The present
system was highly fragmented and had become costly in servicing and
maintenance. Moreover, the aged technology did not meet the growing
demand for translating manufacturing strategies into plant systems
priorities. The French subsidiary is a strategic Roche manufacturing
plant designed for high-volume throughput and operational efficiency.
It was thus selected to serve as a pilot plant for development of a
global system of the Roche group and for the implementations in
Turkey, Spain, and Italy scheduled in the near future.
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Completion of MES update and extension pilot
project at Laboratoires Roche Nicholas S.A.,
Gaillard, France.
Laboratoires Roche Nicholas S.A. is located in Gaillard,
France, in the region southeast of Geneva. The company
produces the largest amount of OTC sales units of all
plants within the global Roche group. The French
subsidiary counts a total of 620 employees on an area
of 97,100 square meters.
Project objective
Roche decided to replace the heterogeneous MES with a standardized
Propack Data PMX MESTM solution. The core objectives in the scope of
this project were direct derivates of the current key drivers in the
regulated industry:
- Optimize manufacturing
- Reduce time-to-market
- Drive regulatory compliance
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With the new integrated system, Roche Gaillard aimed at automated
planning, management, and traceability support in the manufacturing
area. Y2000 and GMP compliance were important issues as well as
version control, configurable access, and audit trail. A complete
interface to SAP R/3 as well as to the existing production facilities
was also planned to be implemented in the course of the project.
Project Procedure
The general project started in 2000. After Roche had submitted the
general requirements, a detailed conception was developed in close
cooperation with Propack Data specialists. The general project
schedule was subdivided in two stages starting in April 2001 and
ending in November 2002.
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Stage I: Rockwell Automation’s Propack Data specialists started the
project with the preparation of appropriate user requirements specifications and the general project plan. Further documents such as detailed
procedures and reports for system tests and acceptance followed.
These documents provided a solid basis for targeted execution of the
individual implementation steps and reliable validation of the system
components.The following functionalities were realized during stage I:
- Complete SAP interface with the support of the IT department
- Propack Data PMX Recipe MESTM for version-controlled management
of pharmaceutical recipes and the complete master data on
shop-floor level
- Propack Data PMX Schedule MESTM for comfortable support of
SAP R/3 rough-cut capacity planning as a basis for finite scheduling
along the entire production chain from weighing through packaging
With the approval of the functional and technical specifications (FTS)
including the entire software qualification, stage I was completed.
Operation started in January 2002.
Stage 2: The second project stage focused on the implementation of
process-related functionality. The following function sets were
integrated during this stage:
- Propack Data PMX Warehouse MESTM for material handling and
warehouse control with an interface to warehouse automation
which processes transportation, storage, and removal orders.
- Propack Data PMX Dispense MESTM for weighing and dispensing
- Propack Data PMX Visual MESTM for evaluating all production data,
creating batch documents, for order processing and line monitoring
www.propack-data.com
with an interface to the automated production facilities
- Deviation handling
- GMP-compliant material flow control (MFC)
In addition to the technological solutions and the validation services, the
Propack Data team provided continuous onsite support, e.g., knowledge
transfer, key user training, and data migration. Prior to commissioning
of the general system in November 2002, the Propack Data team
conducted accurate system tests and acceptance procedures in order
to secure a successful start.
Project Success
Throughout the entire project, the Propack Data team collaborated closely
with the responsible Roche staff and carefully considered the actual
and planned system states in order to develop the most suitable solution.
Since commissioning on Nov. 12, 2002, the new Propack Data PMX MESTM
is running without any major bugs at Roche Gaillard. According to the
Roche Global Global MES steering committee meeting and the Roche
Global MES Manager Mr. Robert Fretz, Roche is very satisfied to have
achieved almost 100% of the former delivery capability after only
10 weeks. “The new system has helped improve our workflow considerably", says Mr. Michel Doucet, Production Manager at Laboratoires
Roche Nicholas S.A., Gaillard. “Management of user access, general
planning, and the traceability of actions, for example, have become
much easier. The project was very complex taking into account the
switch from our existing MES system to Propack Data PMX MESTM,
the validation according to the Computer System Validation (CSV)
guidelines, and the training of more than 200 people. The keys of
success of this project were the high level of professionalism of
Propack Data, the experience of Gaillard concerning MES, and the team
spirit between Propack Data and Roche Gaillard to drive this project.
Furthermore, we expect that the enhanced functionality, the possibility
of evolution, and regulatory consistency will not increase total IT costs”.
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Summary
As a result of this extensive MES pilot project in Gaillard and the MES
implementation in Turkey scheduled for completion in Sep. 2003, Roche
has selected Rockwell Automation as global MES vendor.
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Authors:
Michel Doucet, Production Manager, Lab. Roche Nicholas S.A.
Fred Schiffmacher, Director Services EMEA, Propack Data GmbH
www.rockwellautomation.com
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