Software streamlines pharmaceutical manufacturing processes.
Press Release Summary:
PAS-X provides an integrated, paperless system to streamline manufacturing, decrease cycle times, increase equipment efficiency, and assure compliance within FDA-regulated (including 21 CFR Part 11 and GMP) production and packaging environments. It reduces work in process (WIP) up to 20%, reduces lead times up to 35%, reduces cycle times up to 45%, reduces paperwork by 55%, and reduces data entry by 75%.
Original Press Release:
Werum's Manufacturing Execution System (MES) "PAS-X" Provides Far-Ranging Benefits for Pharmaceutical Industry
Software enhances compliance with GMP and 21 CFR Part 11, while streamlining production and saving costs
TOWACO, NJ - Werum Software and Systems' field-tested Manufacturing Execution System (MES) "PAS-X" is offering important new advances to the processing of pharmaceuticals, it was announced by Dietmar Mueller, director of sales and operations at Werum America, Inc.
According to Mr. Mueller, the system provides pharmaceutical companies an integrated, paperless software solution that streamlines their manufacturing process, improves product quality, decreases product cycle times, increases equipment efficiency, and assures compliance within FDA-regulated (including 21 CFR Part 11 and GMP) production and packaging environments.
From shop order release to finished products.
Featuring total information integration, Werum's PAS-X standard package offers companies a complete preconfigured business processes solution for manufacturing that encompasses:
oproduction planning and scheduling
opaperless recipe management
omaterial flow control and work-in-progress tracking
owarehouse management
oweighing and dispensing operations
oprocess monitoring and line control for production and packaging
opaperless batch control and recording
oproduct evaluation and calculation of Key Performance Indicators
oassurance of regulatory compliance
osystem validation documentation
New levels of accuracy and integration.
In addition to providing total information and processing integration, Werum's MES is highly flexible in its application. In bringing new levels of accuracy to documentation and execution while enhancing product quality control, the system
enables either a single processing site or multiple sites to be completely integrated. By making information on a global scale instantly available, Werum PAS-X can also integrate worldwide production chains.
As compared to paper/manual processes, Werum's MES-supported processes provide:
opaperless manufacturing recipes
opaperless in-process control inputs
oenforced process sequencing
oelectronic "go"/"no go" decisions
othe generation of electronic batch recording
oautomated KPI data collection and calculation
Werum's PAS-X also allows only authorized users to process materials and documents utilized in process operations.
In the area of cost and time saving, Werum's MES provides company-wide efficiencies that can:
oreduce work in process (WIP) up to 20%
oreduce lead times up to 35%
oreduce cycle times up to 45%
oreduce paperwork by 55%
oreduce lost paperwork by 60%
oreduce data entry by 75%
(Source: the Manufacturing Execution System Association)
"The system is perfect for a total production environment."
"With Werum's PAS-X, the supply chain can be truly and completely integrated," Mr. Mueller concluded. "The system is perfect for a total production environment, no matter what size, for one product or for any number of facilities. Providing
quicker improvement of product quality, faster regulatory compliance, and information that is instantly available, the system offers benefits that all add up to savings in virtually every manufacturing department." Werum's Manufacturing
Execution System (MES) is backed by the firm's worldwide local support with 24 hour, seven days a week access.
CASE STUDY: NOVARTIS PHARMACEUTICALS CORPORATION
Novartis Pharmaceuticals Corporation's manufacturing facility in Suffern, New York is currently implementing Werum Software and System's Manufacturing Execution System (MES) "PAS-X."
Commenting on the integration of Werum's PAS-X at Novartis, Richard Lemire, Pharmaceutical Operations Director of Automation and MES project manager, said that the system was chosen for its potential for "increased compliance, increased process robustness and cost savings, and the facilitation of batch
record management and its approval."
Mr. Lemire called the system "quite adaptable to our different processes," and explained that it will be used at the Novartis Suffern facility for all products, from ERP shop order release through approval of finished products.
Werum's PAS-X was chosen by Novartis for a number of unique benefits. According to Ralph Hafeli, Novartis global project support manager, Werum provided "the best match available for our 'standard-functionality' requirements. With a large and proven track record of successful implementations in the
pharmaceutical industry, including pilot testing, Werum not only has the pharmaceutical know-how, but offers competitive pricing as well.
"Their commitment to manage the integration with any existing and newly-selected third party systems and products, their commitment to support a globally coordinated implementation made Werum the right choice for us," he said.
For more information, contact Dietmar Mueller, Werum America Inc., 44 Indian Lane East, Towaco, NJ 07082-1032; phone: (973) 257-0808; fax: (973)257-8824; or visit the company's Web site at www.werum-america.com
