We offer Complete ERP Software Solutions for all kinds of Pharmaceutical & Chemical industries.
BMR for Pharma:
BMR for Pharma is very critical for Pharma Manufacturing for various reasons. Even today, surprisingly, lot of big pharmaceutical manufacturing companies have been capturing the batch manufacturing details on paper. This paper based BMR involves lot of effort in printing all the process parametric data from different process steps of the batch manufacturing. Human beings have to walk across the manufacturing floor, collect these paper printouts, compile them and sometimes, they may have to repeat this process and manually got to verify the same by respective QA individuals. This is a cumbersome process
21 CFR Part 11 Compliance
• Electronic audit trail function automatically generated for all operator entries
• audit trail completely outside the control and access of users (except for read-only access of the audit trail file)
• Impossible to disable audit trail function
• System date and time protected from unauthorized change
• Data changed or deleted, all previous values still electronically available
• Procedure for reissuing forgotten passwords
• Signature made up of at least two distinct identification components, such as an identification code and password
• Records created for all GMP-relevant changes and deletions (a system generated “audit trail”)
• Change or deletion of GMP –relevant data there is a provision for mentioning the reason
• Password forcing the employee to change
• Full Transaction Log
• Routing Mechanism & Authorisation
• Transaction Log methodology
• Fully complaint with latest security standard
• Secured enough to be deployed in defense like environment
• System will be immune to network hacking and cracking
• 100% Network log
cGMP Guidelines
cGMP Features
• Complete Access controls for View,Modify and Authorize
• Complete traceability of user in the system
• Purchases can only be made based on approved manufacturer as well as approved
•vendor list
• Quarantines the material once receipt
• Allowance of extra material receipt can be defined separately for Raw Material and
•packing Material
• Material Can only be issued if QC is Passed
• Extra Material for Batch not issued without Proper Authorization
• Adjustment of Material according to Assay and Loss on drying
• Intermediate Material QC for a batch
• STP for QC
• Batch Release by QA
• Concept of planning both based on Make to Stock and Make to Order
• Complete Machinery Maintenance Module with calibration schedule
• Document can only be printed once approved
Special Functionality for Pharmaceutical & Chemical companies. API & Drug Manufacturing.
1. We have added some Spacial views for easy to operate your production processes and operations. with help of them, you can improve your productivity.
2. Generate Complete eBMR Report (Batch Manufacturing Report) fully linked with production Operations.
3. Easy to operate by an end user and fully mobile & any device friendly.
4. Product-wise specifications & Quality checks and inbuilt formulas for accurate information.
5. Auto formulas linked in goods receipts, issue and production like assay, moisture, net priority, overage, and conversion management. (We customize & add formulas as per need)
6. Planning & execution of your production batches with available resources and workers with various smart functions.
7. Monitor your operations, production status, workload, and resource availability with mobile and take appropriate action as needed, with no need for physical availability.
8. Control available stock, stock expiry & expiry alerts with the indication to control stock and correctly use your inventory.
9. Easy to analyze your fulfillment, demand, production and supply with algorithms to reduce your inventory cost.
10. Easy to manage your preventive maintenance and easy to take action on sudden breakdowns.
11. Inbuilt support tools: Database administrator tool, network monitor, log monitor, disaster planning & recovery tool, email/sms integration tool, report engine
12. Easy to customize, integrate & Develop new functionality so you can fulfill your business gaps.
13. Put your business in auto-pilot mode and only focus on the next.
COMPLIANT & GUIDELINES
21 CFR Part 11
US FDA
WHO
cGMP
Book Your Free Demo – Call us at – +91 9109612027, 9977975607 or write us at support@perlerp.com
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