Equipment Logbook

SOP

Effectively create, manage and store your equipment logbooks

Process XE Equipment Logbook is essentially electronic capture of data of equipment’s in manufacturing plants; mostly other than those captured in electronic batch records.

According to the GMP (Good Manufacturing Practice) manufacturers must maintain proper documentation and records throughout their production process other than the batch records, which includes logbooks. Proper documentation helps to understand the complete manufacturing processes which are necessary for future reference. Regulatory inspectors spend their maximum time in examining the company’s various documentation and records. Effective documentation reflects quality of company production.

Manufacturing companies faces several challenges when they make use of manual paper-based logbooks:

  • Manual recording is difficult for equipment calibration, maintenance, cleaning, operation usage, logs with manual paper-based method
  • Insufficient logs of equipment maintenance, calibration, cleaning, operation logs
  • Manual data entry in logbook leads to reduce productivity, irrelevant data entry, errors, deviation, batch running time mismatch etc.
  • Tracking of paper-based logbooks are very complicated & time taken process
  • Physical logbook needs proper review, as written details are as per ALCOA or not. This activity consumes many hours of production personals to do it effectively and as per SOP’s. If any correction is there in filled logbook, then it’s very lengthy process to make it correct. As per SOP, the person must put authorized sign & date along with the appropriate reason on prepared document for changes in Logbook. This whole process becomes a headache for users.

To fight with all this problems Sarjen system designed a separate solution called Equipment Logbook that take care of all these challenges across the manufacturing processes in one click.

ProcessXE Equipment Logbook automate shop floor by managing Area & Equipment’s operational usage, Cleaning status, Breakdown logs, Clearance logs, Preventive maintenance, Calibration records, and many other equipment details log.

ProcessXE Equipment Logbook is the Sarjen System’s total solution to alters manual paper-based logbook into electronic Equipment Logbook with efficient equipment tracking & automates cleaning, maintenance, and calibration management records. It streamlines the time-consuming nature of manual recording-keeping, including the hassle of finding a pen and the frustration of paper signoffs. You can enable quick review and approval of equipment status, as well as implement electronic signature verification and approval with ensuring compliance with regulatory such as 21 CFR part 11, Eu Annex 11 for better experience to our clients on shop-floor.

Sarjen system has online Equipment Management solution which is specifically designed for regulated pharmaceuticals environment. It facilitates all cleaning validation rules that need to be applied to equipment and for environments that need full track and trace functionality.

The immediate benefits of ProcessXE Equipment logbook ensure that:

  • Prevent incorrect usage of equipment
  • Eliminate paper usage logs and save time generating, completing and reviewing usage logs
  • Have complete traceability in an electronic history, with filtering for the specific information requested (e.g., to give to an auditor)
  • Maintain your process in a controlled and therefore validated state

 

ProcessXE Equipment logbook solution facilitate:

  • A simple & user friendly Interface
  • Flexibility to model any equipment such as rooms, booths, weigh balances & machines
  • Equipment logbook lifecycle management – create, review, approve & version control
  • Tracking of operation usage of equipment as well as area
  • Seamless integration with EBR
  • Clear visibility of equipment status & improved decision making
  • Electronic signatures for authentication of activity
  • Audit trails for data integrity

 

Different logs that our ProcessXE Equipment Logbook records:

  • Area usage logs
  • Equipment operation Logs
  • Equipment maintenance Logs
  • Area/Equipment cleaning Logs
  • Equipment calibration logs
  • Area/Equipment breakdown logs
  • portable equipment logs
  • Accessories cleaning logs

Sarjen system’s Equipment Logbook is well suited to keep equipment records in electronic form. Quality Control (QC) labs are also adopting this solution of Sarjen system in order to maintain their logbooks electronically. If you would like to discuss how your business can get more benefit through Sarjen system Equipment Logbook, contact us.

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