Latest New Product News from
Werum IT Solutions America, Inc.
With PAS-X v3.1.7, dialog for electronic batch recording supports production plant personnel in performing tasks. Information is displayed in way that allows operators to work intuitively, allowing them to focus on most demanding aspects of work while still being able to find additional information at any time.Â Depending on device, users are displayed dialog that has optimal size. All... Read More
Intended for pharmaceutical and biotechnological production, PAS-X v3.1.6 offers extended control of storage conditions and automation of basic functions, optimizing both production security and efficiency in creating Master Batch Records or executing Electronic Batch Recordings. Alarm and event handling ensures optimized shop floor integration and guarantees continuous processes as well as... Read More
Based on best practice of industry and directed by PAS-X User Community PFU, PAS-X MBR Design Elements Content Packages help pharma and biotech customers implement PAS-X MES projects. Products accelerate creation of MBRs (Master Batch Records) and help ensure quality MBR design in configured system. Driving efficiency in global organizations, MBR Design Elements provide framework for harmonizing... Read More
Available for PAS-X Manufacturing IT Business Platform, Generic Master Batch Records minimize number of MBRs by combining processes which always have same workflow and only differ from each other in values of their parameters. This especially applies to field of packaging, where there are large number of different MBRs due to many product variants. When using GMBRs, PAS-X retrieves current... Read More
PAS-CAPA system maps procedures and electronically executes workflows required when deviations occur during manufacturing process of pharmaceuticals. Fully compliant with GMP requirements, integral functions support quality management in terms of acquiring, assessing, and documenting deviations, revisions, and customer complaints; observations during tests; requests for changes; and resulting... Read More
Intended for continuous improvement of product and process quality, web-based PAS-CAPA aims at employees who are concerned with quality assurance, quality control, regulatory affairs, and/or manufacturing. Software collects, assesses, and documents deviations from standards, revisions, customer complaints, investigational findings, change requests, and ensuing corrective and preventive actions in... Read More
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,... Read More
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... Read More
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Werum IT Solutions America, Inc.