Electronic logbooks, eLogBooks, or e-logs in the pharmaceutical industry aren’t exactly new. Many manufacturers have been using software for years to track equipment, production, and manufacturing of raw materials and finished goods. eLogBooks reduce paper use by eliminating paper documents, improving visibility into production processes, automating data collection with manual data entry, implementing risk management protocols, standardizing performance metrics, improving compliance with regulatory standards, centralizing data for analysis, and streamlining inventory management.
However, the question remains, “How do digital logbooks achieve these benefits?” Furthermore, how do electronic logbooks even work? Below, we will discuss how electronic logbooks work and why it is important for pharmaceutical, life sciences, and biotech companies to adopt eLogBooks.
Thinking Digitally – How Do Electronic Logbooks Work?
An e-logbook is an application that manages logbook activities digitally. An eLogbook does not require paper to store logbook entries such as manufacturing equipment usage and maintenance, cleaning, calibration, repairs, and other equipment-related activities. Instead, information is recorded via a mobile app or browser. As a result, the risks associated with managing paper logbooks, such as human error, compromised data integrity, compliance risk, and transcriptional errors, are avoided.
With eLogbooks, every entry can be easily recorded. Entries to the electronic logbook are automatically saved with required authorizations. This feature beats the paper logbook storage, which can easily be misplaced or lost due to other natural causes.
eLogBook entries can be categorized and arranged in a sequential pattern, with an automatic date, time, and equipment. Not only does this ensure that entries, reviews, and verifications are input quickly, but it also prevents the risk of miscalculation and protects the data’s integrity.
Also, unlike paper logbooks and use-logs, eLogBooks are not limited to a single location. Users can access them via different mobile devices, tablets, and PCs, regardless of their operating systems, through a supported browser. You can be anywhere in the world and access the eLogBooks you are authorized to.
Authorized access and compliance with regulations is essential in pharmaceutical and biotech manufacturing. Electronic records must document who performed specific tasks, outlined in USA FDA 21 CFR Part 11 and EU Annex 11. Only specific people should access the logbook entries or capture new entries. This ensures that outsiders and staff of the pharmaceutical companies without authorization are denied access to the logbooks, and maintains a robust audit trail of activities.
eLogBook Benefits for Pharma Companies
The use of eLogBooks in pharmaceutical and biotech companies has some benefits they must not miss. These benefits save companies a lot of time and money and prevent risks associated with a paper logbook. The use of eLogBooks benefit pharma companies in the following ways:
1. Eliminates Cost of Paper Logbook Maintenance
Records of entries made in paper logbooks are constantly maintained and stored to prevent damage or data loss. However, instead of constantly spending on voluminous paper logbook maintenance, eLogBooks are cost-effective with a more promising result. It integrates and synchronizes all the information and entries into a single location, all of which can be accessed at once without going through numerous paper logbooks.
2. Manages Activities Of Manufacturing Equipment
Electronic logbooks effectively manage the statuses and activities of manufacturing equipment in pharma and biotech operations. It updates equipment usage, maintenance, and repairs in real-time with an audit trail. Electronic status management is essential to achieving the right first mine manufacturing. This means that only the right equipment is used at the right time for error-free production.
Another feature that beats the use of paper logbooks is record and digital entry accessibility. Unlike paper logbooks, eLogBooks can be accessed from any mobile device or the appropriately supported web browser. This means you don’t need to get to the logbook storage center to find information on logbook entries or even input entries into the logbook. This feature enforces data access to only those who are authorized and should be a vital part of pharmaceutical companies.
Parameters of logbook entries can be configured on eLogBooks, depending on the data provided. eLogBooks are highly flexible, and configurable. This enables a high degree of form re-use. Also, you can view the data in different formats, and export to your organization’s reporting tools to manage and monitor remotely.
Why Use Electronic Logbooks in Pharma?
Other than the above benefits of using e-logbooks, pharmaceutical manufacturing, cell and gene, and biotech companies need to consider the following reasons why they need eLogBooks:
1. Protection of Data Integrity
Nothing is as important as protecting data integrity in pharmaceutical companies, and that’s one of the risk factors of paper logbooks. With an eLogBook, you can avoid the mistakes of inputting wrong entries. As a result, you will avoid consequences such as fines and sanctions. The system can enforce pre-specified data entry types to ensure that the right values are recorded at the right time. With review by exception, the system can act as a reviewer, to reduce the amount of time needed for quality and manufacturing review cycles.
Transparency in dealing with information about operations within the company is quite important. For example, entries regarding production, organization, and maintenance in the company are visible to staff. This will promote diligence amongst staff as they will become aware that their activities are visible to other people.
3. Prevents Data Loss
Data loss is like a plague that cannot be completely avoided, especially when dealing with voluminous paper logbooks. Anything could happen during transfer (for audits/inspections) and storage. However, with eLogBooks, there is no need to worry about data loss.
All entries in the digital logbook are stored on premise or in the cloud and can be accessed anytime without the need for transfer.
4. Saves Time And Effort
Working within pharmaceutical and biotech companies requires a lot of time and effort, which are rare enough. eLogBooks reduce quality and manufacturing review cycles, to allow your team to focus on other activities. You don’t have to spend unnecessary time and effort inputting entries and reviewing the records.
5. Ease of Use
Due to appropriate parameterization and organized archiving, eLogBooks are simpler to author and execute. You can access them on mobile devices, input entries whenever you want to without delay, and can access the data with ease during review, audits or inspections.
The benefits of eLogBooks in pharmaceutical manufacturing and biotech operations will always exceed the use of paper logbooks. eLogBooks are efficient, and minimize errors. Learn how to kickstart your digital transformation and deploy electronic logbooks, with OpsTrakker.
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