One of the biggest barrier to achieve lean manufacturing in the manufacturing industry is the excessive use of paper-based processes. However, industries today are aggressively adopting to modern IT solutions to streamline, automate and simplify their processes to enhance productivity, efficiency and quality.
An electronic batch record (EBR) software or electronic batch manufacturing record (EBMR) module of ProcessXE is a web-based solution which automates the manufacturing industries processes from raw material through manufacturing to packaging and are essentially electronic capture of data in various operations of manufacturing industry.
EBR is used in conjunction with the many regulatory bodies. It helps all regulatory body to ensure product is manufactured correctly with all required data and through proper recipe method with compliance to ALCOA. Also ensures transparency in whole manufacturing cycle with compliance and easy integration with other systems like TMS, LMS, SAP.
EBR module is total solution to alters manual paper-based processes of manufacturing into electronic system with standard approval cycle 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, GAMP, GMP etc. for better experience to our clients on shop-floor.
According to the GMP (Good Manufacturing Practice) manufacturers must maintain proper documentation and records throughout their production process. 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.
EBR software provide complete facility to create, organize & maintain master production control records (MPCR) which contains work instructions, process steps/recipe, in-process data capture fields, list of SOPs/production checklist to be used, list for raw materials.
This smart manufacturing software solution helps to capture right data with right time by right person in batch process control record (BPCR) & generate significant report and statistics to evaluate and monitor manufacturing process and its outcome.
EBR enforces compliance, reduces the review cycle time in turn decreases the cost of manufacturing. With more strict and stringent rules and regulations especially in pharmaceuticals and biosciences, organizations are compelled to provide right information to the right party at the right time. Effective documentation reflects quality of company production.
In fast changing digital economy, people, systems and machines are interconnected and best implementations optimize use of this interconnectivity to produce expected results. As manual paper-based processes are prone to human errors and time consuming which leads to increase in production cycle time, review time and inventory which in turn increases the storage costs. All of this adds up to higher operational costs and lower profits.
Companies nowadays are compelled to digitize and automate their business processes to improve production efficiency with lesser production time & cost.
Sarjen system’s electronic batch recording (EBR) software automate the execution and review of batch records, bring significant compliance and cost saving benefits to any manufacturer in cGMP-regulated industries.
Key features of EBR software:
- Master product template lifecycle management – create, review, approve, version control and distribute
- Production checklist lifecycle management- create, review, approve, version control and distribute
- Seamless integration with enterprise system, LMS, TMS, QMS, DMS, level 2, etc.
- Real time data capturing while integrated with level 2
- Comprehensive audit trails and deviation reports
- Custom reports and trending analyses
- Electronic signatures for authentication of activity
- Audit trails for data integrity
- Process & product tracking
Quick benefits of EBR software:
- Reduced operating cost by 30%
- Improves visibility to manufacturing processes
- Boosts asset & equipment utilization by minimising down time & predicting maintenance
- Ensures adherence to production specification
- Enable almost paperless production
- Anytime audit ready
- Ensures compliance in alignment with 21 CFR part 11 & annexure 11
Sarjen system EBR is well suited for recording the documentation & keeping the records in electronic form. Every batch manufacturing industries are adopting this solution of Sarjen system in order to maintain their batch record electronically. If you would like to discuss how your business can get more benefit through Sarjen system EBR software, contact us.