The PAS-WD Start-up Package is the classical first-step product for a modular, paperless MES production environment. PAS-WD is a standard weighing and dispensing system designed especially for the pharmaceutical industry, and it supports all requirements of GMP-compliant production.
Main features:
Systemguided "easy-to-operate" workflows
Fully automated dispensing and filling controls
Campaign processing
Scale calibration and management
Container management for weighing operations
Complete integration with ERP systems
Standard interfaces to all commercially available brands of scales
High level of equipment integration into complex material flow control systems
Compliance with FDA/GMP requirements
21 CFR Part 11-compliant electronic records / electronic signatures
The PAS-WD Start-up Package enables you to introduce a MES system with minimum risk and a manageable investment. Due to its modular structure, the system can at any time be upgraded to a functionally complete, paperless PAS-X Manufacturing Execution System.
The system electronically adopts the weighing orders directly from the ERP system, then executes and documents them. PAS-WD acquires material consumption data as well as adjustment postings associated with an order and supplies this information directly to the material management system. Through standardized and certified interfaces PAS-WD can be integrated into all major ERP systems.
Special "out of the box" interfaces are available to facilitate SAP integration, they support all commercially available SAP interfaces and technologies.
There are two ways to integrate PAS-WD in a very flexible manner into order processing workflows:
as a standalone weighing solution based on manual order input
as an integrated system interfaced with intelligent ERP- and MES-based order control systems
PAS-WD provides, in addition, a wide scope of functions, such as required to allow efficient campaign weighing planning as part of the weighing and dispensing process.
PAS-WD permits a high level of integration with material flow control systems as well as the flexible handling of the addition of materials based on the content (potency) of:
raw materials
active ingredients
compensating materials
auxiliary ingredients
The weighing functions of PAS-WD calculate the required quantities of the active ingredients and compensating materials to be used. The integration with ERP or material flow control systems allows the selection of materials according to the reservation or FIFO method.
With respect to the handling of materials the system fully supports the operator by displaying standard operating procedures (SOPs) for material handling as well as important hazardous material information and safety precautions to be observed while handling these materials.
Apart from the flexible processing of input material batches, weighing operations in batch-based pharmaceutical production environments also involve the proper handling of multimaterial intermediate and finished product batches that have been weighed together. PAS-WD supports and facilitates the change of batches by providing the required material identification and documentation. PAS-WD generates a weighing report and adds it to the batch documentation. PAS-WD makes material postings and inventory reconciliations via interfaces directly in the higherlevel ERP system.
PAS-WD detects all deviations and offers an electronic workflow to process them.
Comments on recorded deviations can be entered at any time. Easy-to-understand traffic light functions alert the operator in time to possible violations of defined limit values. The system documents all deviations and makes them available to the responsible persons and departments for assessment and approval.
A set of interfaces to commercially available CAPA systems is also included.
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