- March 11, 2020
- Category: Manufacturing Execution System
The focus for pharmaceutical manufacturing productivity gains is depend on completing batch history records, other area that can make a remarkable contribution to reducing release times is equipment management.
eLogbook/eForm module of our ProcessXE covers everything to do with controlling and tracking the usage information of equipment and area operation, cleaning & maintenance, etc. It covers everything that may currently have in a paper logbook. Also have an audit trail for traceability of every log.
Hurdles with manual logbook:
- Under Preventive maintenance equipment used
- Clearance not properly completed before using the equipment
- Chance of Data Integrity while manual usage logbooks/Forms.
eLogbook can however be quickly automated to manage the allowable states that equipment can transition from or to.
ProcessXE has eLogbook functionality that has been specifically designed for regulated life science and pharmaceutical environments. It provides for all cleaning validation rules that need to be applied to equipment and for environments monitoring that need full track and trace functionality also, It has a control over operation execution batch to batch and product to product change over, when equipment under maintenance, cleaning and operations.
It includes essential functions such as time triggered equipment state changes, where area or equipment requires re-cleaning after a defined period of time has elapsed, then system will automatically move it to a “uncleaned” state.
Quick features of eLogbook:
- A simple and easy evaluation between Equipment status and its use
- Fully configurable software
- Automatic and/or manual state change capability (e.g. clean, available, in-use, busy, requires maintenance). Example, when equipment available after clean, the status can be manually or automatically changed to “Available” from “Clean”
The immediate benefits of eLogbook:
- Eliminate 100% paper and save time to generate, review and approve eLogbook.
- Have complete traceability in an electronic history (Audit trail), with filtering for the specific information requested (e.g., to give to an auditor)
- Prevent wrong usage of equipment (e.g. using dirty equipment or past due equipment)
- Maintain your process in a controlled and validated state
Understanding the time constraints in manufacturing, Sarjen has developed a rapid review process which can automatically calculate business benefits from key data. If you would like us to provide this for your business or discuss how your business can benefit from eLogbook/ eForm, kindly contact us.