Quality control is of vital importance during the manufacturing process. Its objective is the continuous control and improvement of product quality.
The PROCESS QUALITY CONTROL business function offers you the PAS-X functionality that ensures a continuous monitoring of the production quality. With this business function, you can process any deviations from the specifications during ongoing manufacturing operations. But, more importantly, you can use functions that support process-analytical on-line, in-line, and at-line quality controls to take preventative and flexible measures in order to achieve the highest possible quality. PROCESS QUALITY CONTROL supports you as you implement Process Analytical Technology (PAT) and state-of-the-art Quality by Design (QbD) concepts.
PROCESS QUALITY CONTROL supports qualified persons in their daily work. Quality Control Dashboards can be configured in flexible ways to show deviations in the different manufacturing and packaging sectors on intuitive traffic light displays. The qualified person can directly intervene, down to the batch record level, evaluate deviations with appropriate audit trails, and take appropriate measures - all with a simple mouse click.
Deviations are actively displayed. You don't have to hunt for them.
Deviations / events may directly initiate a CAPA process in an external system, e.g., Trackwise®. Standard interfaces to the CAPA system are available "out-of-the-box" (OOB).
The step towards paperless documentation is a milestone on the path towards more reliability and documentation quality in the pharmaceutical manufacturing sector. Electronic user prompting guides the operator securely through all production steps of the manufacturing process. PROCESS QUALITY CONTROL is a logical and consistent add-on to the ELECTRONIC BATCH RECORDING business function. PROCESS QUALITY CONTROL, with its core function of workflow-based deviation management, makes good use of all the benefits of Electronic Batch Recording, and it safely controls all critical parameters.
With the help of the ELECTRONIC BATCH RECORDING business function, all set values and tolerance bands are uniquely specified within the process, and are electronically verified. On recognition of deviations, PROCESS QUALITY CONTROL informs the operator and prompts for a response.
The electronic early warning mechanisms in PROCESS QUALITY CONTROL enable the user to take corrective action regarding the production process the moment any negative trend is recorded. Every single deviation is documented.
The system prompts the operator to classify recorded deviations and to add a comment. At the same time, PROCESS QUALITY CONTROL checks whether a second electronic signature is required. The criteria for required second signatures can be customized within the system. Furthermore, subsequent actions can be parameterized. The system can therefore, for example, in the case of defined deviations, prompt the operator to notify the supervisor in charge before continuing with the process.
An electronic workflow ensures that deviations can be evaluated by different members of staff and various departments. This method delivers two vital benefits: On the one hand, time-consuming distribution of paper documents becomes redundant; on the other hand, target and actual process data, required for evaluation, are made readily available.
PROCESS QUALITY CONTROL creates an electronic Deviation Report for the Electronic Batch Record. The deviation report is part of the electronic batch record. A condensed report of all deviations allows the batch record to be released efficiently and with no unnecessary delays. The release process is controlled by a parameterizable electronic document workflow.
Once reported and evaluated, the deviations are stored within an audit trail. The system documents electronic signatures in compliance with the 21 CFR Part 11 requirements.
PROCESS QUALITY CONTROL therefore improves the performance of all release processes and, at the same time, fulfils compliance regulations regarding the documented pharmaceutical release process.
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PAS-X Funktionen
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