GMP Logbooks in pharmaceutical manufacturing companies
All the pharma manufacturing companies are required to keep logbooks in place for documentation of usage logs of equipments, calibration, preventive maintenance, environmental conditions, cleaning, repairs, quality control logs, stability logs and other major equipment logs and needs to comply with Good Manufacturing Practices (GMP) regulations. They maintain different sets of logbooks depending on the nature of activities being carried out in day to day operations. Typically, the majority of logbooks are paper based using bound paper log books with a sequentially numbered pages to prevent pages from being removed and replaced from it.
There are Standard Operating Procedure (SOP) that regulates the responsibilities and describes the procedure for creating, managing logbooks and registering log entries manually, consistently and contemporaneously.
Electronic Logbook provides a simple and easy-to-use, cost and time saving tool for highly regulated industries like pharmaceuticals, life sciences, biotech, bio-pharmaceuticals and other drug manufacturing company wide enforcing and supporting of FDA and GxP compliance efforts in the areas of logbook registrations in all its paper forms.
The web based application comply with FDA 21 CFR part 11 compliant requirements such as electronic signatures, multi-level password authentication and complete activity time stamped audit trails to ensure data integrity for regulatory purposes, eliminating human errors and tampering risks.This E-Logbook Application enable the life sciences companies for controlling and tracking the usage information of equipment and area operation, weighing balance logs, instruments logs, calibrations, working standards logs, cleaning & maintenance, etc.
The eLogbook provides the ability to view, search, track and report on historical equipment data for event tracking and in support of decision making process as well as for trend analysis. The electronic logbook has an intuitive methodology to enter the information, which ensures that total time spent on identifying the usage logs and capturing all operational information can be minimized
Pharmaceutical Manufacturing companies can use AmpleLogic Electronic Logbook (eLogs) application that eliminate paper based documentation errors while simplifying the process.
At the operational level, AmpleLogic E-Log Management System offers a number of functionality features for highly regulated companies that are manually managing paper logbooks or forms
- AmpleLogic eLogs application will meet the compliance requirements with FDA 21 CFR Part 11, MHRA, EU Annex 11, WHO, GMP, and others industry standards.
Ensure Data Integrity
- AmpleLogic E-Log Management System ensures to validate your data inputs, if there is incomplete log forms the system will not allow to submit it to the next process flow. It ensures integrity of data contained in eLogbook with all the data recorded as per your operations
Easy Logbook Configuration
- In life sciences companies, there are many types of logbooks are used in the manufacturing sites and this eLogbook Software enable the users complete flexibility in being able to configure log entries of exactly to the data needed to recorded as per the instructions, including text fields, time and date, drop-downs and check-boxes so on.
- AmpleLogic Electronic Logbook Software can create and design the log sheets (forms), as per the approved SOP’s, like equipment logs, calibration logs, Cleaning/ maintenance logs, production logs, and other usage logs. This eLogs application allows authorized users to create and modify logbook templates very quickly and can be configured to the unique process requirements of each site.
- It automatically manage multiple versions of a logbook with a proper audits available on few clicks, this eLog system does not allow you to access old version of logbooks once the new version is produced. Version control allows you to track all changes who made the changes to the log template and when it is made
- The eLogbook Software can integrate directly with instruments, machines, to pull real time data using PLCs, historian databases, and also other existing systems such as SAP etc.
Mapping of Equipment and Resources to Areas
- AmpleLogic E-Log Management Solution helps in mapping resources and equipments of a specific area of production. Users can cross check the availability of resources and the mapped equipment and instruments, etc. They can use the equipment and users accordingly during the production process in the facilities. In case of non-availability of equipment and users, the concern supervisor will get email notifications regarding particular equipment is scheduled already for the particular process in the production
- Ability to generate custom reports based on user specified KPIs, which are exportable in multiple formats. User shall able to filter records equipment code wise, date wise, month wise, area wise, activity wise, user wise, Batch number and generate valid reports and enable management to make decision making process
- The eLogbook extends manufacturing floor automation by managing and tracking equipment use, cleaning status, maintenance and calibration records with an easy to use web app and mobile App with support for commonly used tablets
Web Browser Access
- You can access your log records from anywhere in the world using a simple web browser still keeping full control over your documents by hosting them on your own server onsite or cloud based system. This will encourages a standard logbook approach across multi-site operations.
AmpleLogic eLogs had been implemented in India’s largest pharmaceutical manufacturing companies to completely eliminate the manual logbooks in the operational areas.