Software aids in biopharmaceutical production.
Press Release Summary:
PAS-X BIOTECH Manufacturing Execution System (MES) meets requirements of fine chemical manufacturing of active pharmaceutical ingredients. Managing electronic equipment usage and performance, monitoring capabilities act as early warning system, making any discrepancies visible before actual occurrence. Package also includes material and batch management, Electronic Batch Recording (EBR) module, and functions for analyzing production, quality, and laboratory data.
Original Press Release:
Werum Software & Systems Introduces PAS-X BIOTECH Production Management System at Achema 2003
First Manufacturing Execution System (MES) specifically tailored for biopharmaceutical production
TOWACO, NJ -- Werum Software & Systems, a worldwide leader in providing manufacturing IT solutions for the pharmaceutical and biotech industries, will present its new PAS-X BIOTECH Manufacturing Execution System (MES) at Achema 2003, May 19-24, in Frankfurt, Germany.
Based on an expanded version of Werum's acclaimed PAS-X Manufacturing Execution System, PAS-X BIOTECH has been designed to meet the specific requirements of biopharmaceutical and fine chemical manufacturing of active pharmaceutical ingredients -- a fast-growing industry.
According to Dietmar Mueller, Werum America's director of sales and operations, PAS-X BIOTECH features numerous sophisticated modules created to prevent quality deficiencies by controlling the entire process to ensure complete compliance with both product specifications and regulatory requirements.
"Maximum process safety is a key factor for value added biopharmaceutical process," he said. The manufacturing process typically lasts several days or even weeks, and any deficiencies can result in the rejection of the entire batch. PAS-X BIOTECH's monitoring capabilities act as an early warning system, making any discrepancies visible even before their actual occurrence so that the appropriate steps can be taken to correct the process. It is self-evident that the package includes basic functions like material and batch management.
"In addition, the system's detailed monitoring functions also manage electronic equipment usage and performance to prevent, for example, the use of equipment that has not been sterilized, such as filters, tanks, or containers."
With its integrated Electronic Batch Recording (EBR) module, PAS-X BIOTECH sets up the prerequisites for paperless production. The system insures compliance with 21 CFR Part 11 on Electronic Records and Electronic Signatures (ER/ES) and secures a safe process data archiving. A deviation report, as part of the electronic batch record, shows discrepancies and events in a clearly structured, summarized form. This provides all departments involved in the production process with a fast, reliable and efficient assessment and electronic approval of the batch record.
Thanks to its comprehensive functions for analyzing production, quality, and laboratory data, PAS-X BIOTECH considerably improves process stability, reduces lead time and provides continuous process improvement. The system is an advanced development of Werum's PAS-X PHARMA, which has a proven track record with leading pharmaceutical companies worldwide.
Werum's international organization provides for efficient and competent global partnerships with its customers through a complete range of specialized services. Built on the hands-on experience Werum has gained in numerous projects, these services cover a broad spectrum of performance-based applications.
Among the services Werum offers are consulting; project management; support services (including a 24/7 hotline); technical coordination and system integration; computer validation; and training for system administrators, system engineers, and end users.
Werum Software & Systems' U.S. headquarters is located at 44 Indian Lane East, Towaco, NJ 07082-1032; phone 973-257-0808; fax 973-257-8824. With world headquarters in Germany, Werum has more than 200 employees and maintains branch offices around the globe.
