E-logbooks for Pharma Manufacturing
Why ProcessXE eLogbooks are the First Inexpensive Step
Many pharmaceutical manufacturing enterprises in the Indian pharma sector continue to rely on paper-based logbooks and records. However, while adopting paper-based systems, these businesses face several hurdles and compliance concerns. Despite meticulously capturing vital data such as equipment cleaning, calibration, maintenance schedules, packaging, weighing, and dispensing in these logbooks, they are vulnerable to compliance concerns, human mistakes, misplacement, and decreased productivity. Furthermore, firms must manually check the logs in line with standard operating procedures (SOPs) and operational standards, which may be a difficult and time-consuming effort. Unfortunately, many pharmaceutical manufacturing organizations fail to recognize the benefit of gathering data and developing useful insights from it. As a result, people prefer to create logbooks Software.
Indian pharmaceutical manufacturers benefit from lower manufacturing resource costs. However, they face significant challenges in terms of human resources and compliance with FDA regulations. They run the risk of losing productivity and incurring substantial costs due to product recalls or FDA warning letters. Even though they may have lower labor costs and rely on paper-based logbooks, the financial impact of such incidents can wipe out their profit margins, making them unable to overlook the importance of these issues.
The industry felt that cost of these systems is more expensive than human resources themselves, but this is no longer the case. This is what has happened in the previous five years with some large Indian pharmaceutical businesses. What the industry requires is a digital solution or a electronic system that monitors all areas of production in real time and maintains strict adherence to compliance requirements such as 21 CFR Part 11, MHRA, and cGMP practices. It’s time for Indian pharmaceutical manufacturing enterprises, to switch to electronic logbook management software’s like ProcessXE, a cloud-based eLogbook system. Organizations can stay concern free regarding audits and compliance concerns since all of our solutions (eLogbook, eDispensing, eBMR and other such process automation solutions) are created in accordance with 21 CFR Part 11 Compliance, following all cGMP guidelines. ProcessXE eLogbook ensures operational efficiency with a simplified approach to automation making the screens and processes operator friendly to avoid complexity.
ProcessXE eLogbook adds more value and simplicity for operators as compared to other solution providers.
There are various vendors providing eLogbook software solutions across the globe, but many of them lack compliance with regulatory guidelines, while others only offer electronic data entry and record keeping
Sarjen customers using eLogbooks, have experienced a growth curve from ProcessXE systems. The benefits of logbook management include real-time 360-degree monitoring of assets, such as equipment, areas, and process steps, ensuring adherence to CGMP standards and many more. Additionally, our solution provides transparency in terms of operations.
One of a leading Pharma manufacturing organization successfully implemented eLogbooks and process automation solution, resulting in improved equipment cleaning cycles and greater output. They used a predictive maintenance plan, which resulted in considerable downtime savings.
ProcessXE Electronic Logbook collects data and delivers actionable insights to improve our customers’ operations and business success. ProcessXE Electronic Logbook software also provides comprehensive analytics, eliminating the need to purchase additional analytics solutions. If clients wish to gather data straight from ERP’s and execute eBMR, ProcessXE provides simplified integration, paving the path for the Pharma 4.0 journey.
How we differ from market?
There are digital Logbook solutions the market; several do not include 21 CFR Part 11 compliance, while others only enable electronic data entry. These do not entail just digitizing your manual processes. If that's the case, any company's internal IT staff can provide you with a variety of forms utilizing any free resources at their disposal.
When our Logbook software were installed, ProcessXE systems were provided to our customers: Real-time 360-degree monitoring of assets such as equipment, areas, and process steps means adherence to CGMP regulations and transparent quality control, among other immediate advantages.
Electronic Logbook and process automation solution increases their equipment cleaning cycles and throughput.
Why do pharmaceutical producers require eLogbooks?
Electronic Logbook are thought to be the initial step in every digital transformation path. They give fundamental vital data characteristics, which may be combined with data from eBMR/QMS/DMS or other modules to create a full guided data-set to support strategic business choices. eLogs minimizes human mistakes and saves significant manufacturing time, resulting in speedier product releases. Predictive maintenance of equipment, complete elimination of paper, enabling manufacturers to meet FDA standards through digitization of all log data, holistic assessment of area cleaning, sanitation, logs, and sample management provide every manufacturer with critical real-time manufacturing insights, ensuring effective operational excellence and increased productivity.
