Effectively create and manage your standard operating procedure (SOP), forms and logbooks
Process XE eLogbooks and eForms are essentially electronic capture of data in various SOP driven operations of manufacturing plants; mostly other than those captured in electronic batch records.
According to the cGMP (Good Manufacturing Practice) manufacturers must maintain proper documentation and records throughout their production process other than the batch records, which includes Standard Operating Procedures (SOPs), Forms and Logbooks. Proper documentation helps to understand the complete manufacturing processes and As-build configuration (ABC) which are necessary for future reference. Regulatory inspectors spend their maximum time in examining the company’s various documentation and records. Effective documentation is a reflection of quality assurance system.
Each SOP driven operation requires complete life cycle of SOP with version control. While eForms provide facility to create and maintain versions of each SOP, eLogbooks offers an intelligent output by using data of multiple eForms to produce various logbooks including equipment logbooks. eLogbook module produces single, comprehensive equipment logbook from data entered separately on equipment use, equipment cleaning and equipment maintenance and so on.
The system capabilities include:
- eForms Lifecycle Management – create, review, approve, version control and distribute
- eForms usage tracking and log
- Integrated with EBMR for batch records
- Effective version control ensures that operators always have effective SOPs for manufacturing the batch
- Trends and Analyses of data recorded
- Clear visibility of manufacturing and improved decision making
- Electronic signatures for authentication of activity
- Audit trails for data integrity