Batch Records Software
Process XE batch records software workflows are 100% configurable. No coding required.
What is a Batch Record?
A batch record is a record of the history of a manufactured product. It comprises processing instructions to assure its safety, quality, and GMP compliance.
As a result, pharmaceutical businesses choose to use Electronic Batch Record (EBR) in order to streamline production and reduce the potential of mistakes seeping in. This article demonstrates how the system facilitates document generation in the pharmaceutical industry, from bulk to packaging processes.
What is Electronic Batch Records all about?
The pharmaceutical business that wishes to apply innovative solutions in manufacturing is concerned with more than just the digitization of forms. The EBR system is also designed to reduce the time necessary to fill out form fields and eventually lead to automatic form completion by gathering data directly from machines. Data collection directly from equipment such as scales, pH meters, and conductivity meters is frequently required as well. Furthermore, the organization wishes to avoid mistakes and track deviations from the standard that occur during the manufacturing process.
The deployment of the Process XE system results in more than just efficient documentation digitalization. Operators are directed through the manufacturing process, which includes changeovers, quality, logistics, and maintenance. Process XE is being compiled using GMP by the system.
This greatly simplified the process of creating or changing forms. However, this still necessitates the use of authorized individuals; only those with the necessary access may make modifications to the forms. All of this is done to avoid mistakes or inappropriate processing.
What does the Process XE solution offer for Pharma?
Process XE provides an all-inclusive solution that includes machine data collecting, hardware, ERP integration, and infrastructure. This method also allows you to create MBR templates. Clients can develop Master Batch Record (MBR) templates by arranging all actions in the system in the correct sequence and assigning responsibility for each role. Each activity may be customized with several reporting data kinds such as numbers, text, and data retrieved from automation, among others. These results can subsequently be checked against the system’s quality limitations.
Fields in forms that have been implemented include whether or not an action has been done. A production value column and information about when a given activity was begun or stopped, as well as a computation of the time spent on it, are also among the modifications. There is also an electronic signature placed on the form and comments or remarks made by the responsible person among the implementations.
What does a paperless procedure in the pharmaceutical sector look like?
The paperless process includes digitally directing the operator through particular portions of production, beginning with the activity display – the production to-do list. It also contains changeover information and documentation for each production phase (picture, text, and video). Using Forms, all paper documentation from production are digitized.
All sheets, tables, and reports are immediately fielded with data from current shifts thanks to Process XE. The system monitors and alerts the operator when the task must be finished. Any modifications or deviations are tracked using an audit trail.
To be released, each batch must go through the Process XE system’s approval procedure. This relates to the workflow aspect. The persons who notify certain positions in the organization must sign each step with an electronic signature. If the current step in the workflow is allocated to a certain role, notifications are issued. People with the necessary rights may observe where the batch release process has halted and track KPIs for the time it takes to finish each step.
Digital Records Management with Electronic Batch Records
EBR works because of all of the criteria mentioned above. This provides digital documentation management throughout the manufacturing process. The system ensures that the essential data is entered into the stages. EBR generation yields a PDF file with finished reports and signatures.
What are the benefits of this for the pharmaceutical business?
To begin, the system reduces batch release time by 35% owing to workflow and automatic data collection. Material validation, frequent quality inspections, and step-by-step digital teaching also result in 15% reduced mistakes and waste. It also delivers a 7% boost to OTIF.
The use of EBR also facilitates speedier communication between business divisions, contributes to the removal of paper from the manufacturing process, and allows for round-the-clock monitoring of current batch release statuses.
Process XE provides the solutions your pharmaceutical company need to improve workflow efficiency and environmental friendliness. Please contact a member of the team for more personalized help.
Process XE is web based, flexible and user-friendly software solutions for Business process automation.
This Digital, Smart Manufacturing process automation is principally developed for Pharmaceutical, Life science and Healthcare industries to simplify their manufacturing execution system of various processes such as data capture, batch information exchange, batch production management, data security maintenance, data integrity and report production, ensuring compliance to cGMP requirements.
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