Cleaning, preparation, and usage log of equipment, instruments, and facilities used in a GMP environment is critical information in any manufacturing environment. Maintaining an equipment logbook is a mandatory requirement, as stated in FDA 21, CFR 211.182, “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.”

A paper-based equipment logbook is inefficient and opens an organization to any number of compliance issues. Recording a logbook entry requires that at least two people be physically present. A required signature from two people for every data entry in a logbook reduces productivity and introduces the potential for errors and/or inaccuracies. In a paper-based environment, reviewing historical equipment logs requires sifting through stacks of papers and binders, not to mention that finding these logs can require navigating through a labyrinth of filing cabinets. Any paper-based equipment log management process will ultimately fail to support a continuous monitoring process.

ValGenesis users have the power to electronically capture cleaning, preparation, and usage logs. Captured logs can be verified and reviewed via controlled workflows. The system allows users to design equipment log forms and their associated labels as mandated by their approved SOPs. Any form and label can be made,as there is no restriction on the number of these that can be created.

Complete visibility for cleaning, preparation, and usage logs

Any log can be created and managed, including calibration, weight check logs, etc.

Logs can be captured and verified through any mobile devices including iOS and Android devices

Real-time status for equipment, instruments, and facilities available in Log inventory

Enforce steps for log recording, verifying/reviewing logs as per approved SOPs and standards

Automatic notifications ensure equipment logs are up to date and verified/reviewed on a schedule

Logbooks are never lost or misplaced, as they are always available in electronic format

Reporting and trending can easily be achieved through ad-hoc reports

Supports continuous monitoring process during production



eLogbook – Electronic Validation Management Software

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Define Your Destiny: GMP Equipment & Instrument Validation for 21 CFR Part 11