ELog Software - Pharmision Barcode India

1. Why Must Pharmaceutical Companies Switch to eLog Management Solutions? - Pharmision Barcode India According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails is essential. Yet, despite its significance, log documentation today is still primarily a time- consuming, paper-based process that puts life sciences manufacturers at serious compliance risk. Data entry by hand in paper logbooks is labor-intensive and prone to error. First, employees spend hundreds of hours creating, reviewing, and approving logs. Then, during audits and inspections, they waste more time locating this information, which is often stored in various physical locations.

2. Drawbacks of paper-based log management The pharma industry has historically needed to be faster to adopt new technology. As a result, many companies continue to follow paper-based log management. However, here are some challenges with this manual and paper- based approach: Reduced productivity: Manually recording log activities uses many resources. Equipment usage logs take time to physically (and methodically) record the date, time, product, and lot number of each batch. It takes just as long to register the necessary cleaning data. As a result, productivity is severely impacted by manual log management. High likelihood of human error: Mistakes are unavoidable because of the enormous amount of information you must log through manual data entries. Your compliance risks significantly increase regardless of whether you entered the information incorrectly or if it is simply illegible. Increased risk of 483s: Inaccurate paper logbooks can result in deviations, Form 483 observations, warning letters, and even regulatory fines and sanctions. Data loss and rework: Paper logbooks can be lost or misplaced due to human error or calamities like fires and floods. Employees frequently spend hours performing the same tasks. These delays slowly down time to market, increase production and overhead costs, and could be more efficient. Lack of visibility: Physical logbooks are often found dispersed throughout an organization. Reviewing historical log information requires sifting through mountains of paper records kept in offsite document storage facilities. When every second counts during an audit or inspection, this can result in a significant waste of time. Offsite storage is expensive in addition to being inconvenient.

3. What does an eLog solution do? An eLog management solution digitizes your area and equipment logs so you can check or review them online. It enables you to record information about a batch, the participants, and the time of an activity from a location or piece of equipment as it occurs, archiving your logs electronically so users can search and retrieve the logs at a moment’s notice. Additionally, it assists in data organization and can present the log entries as actionable reports and analytics. With eLogs, managing your audit is simple, and you can save money on printing, storing, and keeping log documents. By completely eradicating the need for paper, you can store your data securely and access it whenever you like, all while assisting your organization in achieving its sustainability goals. How eLogs assist in real-time Pharmaceutical companies that want to streamline operations and boost their bottom line should consider using electronic log solutions. Here are a few ways that electronic log solutions can assist pharmaceutical companies with real-time analytics: Real-time visibility into operations: Electronic log solutions give users access to up-to-the-minute information on the whereabouts and status of various equipment. Increased data accuracy and dependability: Electronic log solutions automatically collect and store data, guaranteeing the accuracy and reliability of the information.

4. Data analysis: Electronic log solutions can analyze the information gathered around the user, areas, and equipment. This analysis can assist in identifying trends, patterns, and areas for improvement. Predictive analytics: Electronic log solutions can use predictive analytics algorithms to forecast potential future problems before they arise and adjust operations or send alerts as necessary. Compliance with regulations: Electronic log solutions can assist pharmaceutical companies in adhering to laws, regulations, and mandates. Doing so significantly decreases the possibility of fines and penalties, and log management operations comply with industry standards. Conclusion Pharmaceutical companies looking to enhance their operations and achieve the highest log management standard should consider using electronic log solutions. Electronic log solutions can assist pharma companies in optimizing their operations, cutting costs, and increasing customer satisfaction by providing accurate and reliable data, real-time visibility, automatic data analysis, predictive analytics, and regulatory compliance. With years of experience in resolving business issues, our team of subject matter experts created the eLog Management Solution by Pharmision. This configurable tool allows you to create, store, retrieve and analyze your logs to ensure a higher standard of compliance. It can create, design, and store the log sheets (forms), as per the approved SOPs, like equipment logs, calibration logs, Cleaning/ maintenance logs, production logs, and other usage logs. ELogs by Pharmision only allows authorized users to create and modify logbook templates quickly and can be configured to the unique process requirements of each site. It is a scalable, user-friendly solution compatible with your existing systems. If you want to know more about eLog Management Solution, please contact us here or visit the solution page that outlines its key features and benefits.