Effectively create and manage your standard operating procedure (SOP), forms and logbooks
Process XE eLogbook/eForm module are essentially electronic capture of data in various operations of manufacturing plants; mostly other than those captured in electronic batch records.
ProcessXE eLogbooks/eForms module is a web-based software or platform that records general production requirements and tracks down Area and Equipment’s operational usage, Cleaning, Breakdown, Clearance, and Preventive maintenance, Calibration, and many other equipment details log.
ProcessXE eLogbooks/eForms module is total solution to alters manual paper-based processes in logbook into electronic system (eLogbook/eForm) with standard approval cycle like, review, verify, approve to ensure right & complete data recorded in system. Which ensuring the compliance with regulatory such as 21 CFR part 11, Eu Annex 11, cGMP etc for better experience to our clients on shop-floor.
According to the cGMP manufacturers must maintain proper documentation and records throughout their production process other than the batch records, which includes logbooks and forms/annexures. 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.
eLogbook/eForms provide complete facility to create and maintain eLogbooks/eForms for future purpose with versions control of each. eLogbook module produces single, comprehensive equipment logbook from data entered separately on equipment use, equipment cleaning and equipment maintenance and so on.
Challenges with manual paper-based logbooks
- Manufacturing companies faces several challenges when they make use of manual paper-based log books.
- It is difficult to record the details of equipment calibration, maintenance, cleaning, operation usage, stability schedule, HPLC column logs with manual paper-based method.
- Manual data entry in the logbook is 80% leads to reduce productivity, irrelevant information, errors, deviation, batch running time mismatch, data integrity etc.
- Paper-based logbooks, affects batch processes value capturing individual logs in logbook, create many compliance issues.
- 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 proper sign & date along with the appropriate reason on prepared document for changes in eLogbook. This whole process becomes a headache for users.
- Also tracking of paper-based logbooks are very complicated & time taken process.
- To fight with all this problems Sarjen system designed a separate module called eLogbook/eForm that take care of all these challenges across the manufacturing processes in one click.
Key Features of eLogbook/eForm
- eLogbook/eForms lifecycle management – create, review, approve, version control and distribute
- Tracking of operation usage of equipment as well as area
- Integrated with eBMR system for batch records
- Trends and analyses of different logs data
- Clear visibility of manufacturing and improved decision making
- Electronic signatures for authentication of activity
- Audit trails for data integrity
Different logs that our ProcessXE eLogbooks/eForms module 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
- Inprocess container cleaning logs
- Daily cleaning or sanitization logs
- Sample Registration logs
- Sample Management logs
- Sample withdrawal logs
- Column usage logs
Sarjen system eLogbooks/eForms is well suited for recording the documentation & keeping the 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 eLogbooks/eForms module, contact us.