Overview

ValGenesis Electronic Logbook Eliminates the Paper-based Equipment and Facilities Logbooks

ValGenesis Electronic Logbook – Electronic Preparation, Cleaning and Usage Log Management

As part of regulatory requirements, preparation, cleaning and usage logs need to be documented with name of the trained users involved in the process for accountability purposes. For the most part maintaining the log books still requires a high degree of manual effort for tracking and reporting, and the cleaning status of each equipment and facility is documented in a label and attached to the asset. By and large, predominantly paper and manual based log management processes stifle innovation, cause compliance risk and compromise a life science firm’s ability to bring products to the market on time. Plus – with the increased use of computers along with the progression of evolving software technology – a more advanced cleaning and usage log management solution has become essential to the life sciences industry.

ValGenesis LOG
ValGenesis Electronic Logbook is a web-based Electronic Logbook Management Software System that eliminates the need for a paper based logbooks for equipment and facilities for cleaning, preparation and usage activities. The electronic logbook application enables quick verification and review of equipment cleaning and usage logs at the point-of-need, as well as electronic signature verification and approval as required per the SOP.

Regulatory Requirements for Log Management
Maintaining the documented evidence for preparation, cleaning and usage logs is not an option, but it is a mandatory requirement enforced by regulatory agencies which include the following requirements.

21 CFR 211.182 Equipment cleaning and usage logs
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed.

21 CFR 211.56 Sanitation
Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition.

Features

Features of ValGenesis LOG

ValGenesis LOG is highly configurable with the following functions to meet any type of log management requirements:

  • Taxonomy can be defined by end users to classify the GxP equipment and facilities into different folders with required security for easy and secured access.
  • Workflow can be paired with any type of review and approval requirements with required electronic signatures as per the approved corporate procedures.
  • Any type of cleaning/preparation form and label can easily be designed. Forms and labels can be designed by end users with minimal application knowledge.
  • Any type of usage form and label can easily be designed. Forms and labels can be designed by end users with minimal application knowledge.
  • User groups will be alerted for expired usage logs

Process

Common Issues with Paper based Log Management process

Following are some of the common issues with paper-based manual logbooks:

  • Paper based equipment log books can be inefficient due to limited access, missing or inaccurate data and lack of enforcing required signatures.
  • Recording a logbook entry requires at least two people to be physically present.
  • Each signature and data entry in the logbook reduces operator productivity and introduces the potential for errors or inaccurate information.
  • Reviewing current equipment logs requires “gowning up”.
  • Information is not centrally located and available electronically
  • Reviewing historical equipment logs requires searching through stacks of paper.
  • Possibility of missing or inaccurate data
  • A paper based equipment logbookmanagement process does not support the an integrated lifecycle approach and continuous monitoring process required as per the new process validation guidance
  • Logbook entries need to be reviewed periodically to ensure that data have been collected as per the approved procedures. With each piece of process equipment needing a specific logbook, the number of logbooks and the time required to verify these documents can easily become overwhelming. It is a non-value added activity for valued SMEs.
  • Difficult to enforce consistency and possibility for missing equipment and/or facility forms with the routine cleaning schedule which could lead to ‘out of regulatory compliance’.

Benefits

Benefits of ValGenesis Electronic Logbooks

ValGenesis electronic Logbook eliminates the need for paper based records. Logbooks can easily be accessed through a web browser and log entries can easily be captured via any Windows device including tablets. The ability to force the sequence of steps and integrate reference documents – such as SOP’s – helps improve operator efficiency. Alerting out-of-specification data to appropriate users is easily accomplished. Ensuring that all data is complete and accurate is automatic. Proper verification, review and approval can be defined as part of the workflow with required e-sign capability.

  • ValGenesis electronic Logbook provides full visibility for the equipment logs and validation status of equipment
  • Enforce standard operating procedures related to recording, verifying and reviewing equipment logs
  • Access to data is available in real time. “Gowning up” or searching through stacks of paper are things of the past.
  • Automatic notifications to ensure that equipment logs are up to date and have been verified and reviewed on time
  • Logbooks cannot be lost or misplaced
  • Reporting and trending is easily achieved with all relevant data stored electronically in the database
  • Ensures data integrity of the information contained in the electronic logbooks
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