Ensured batch packaging information as per GMP requirements. Also, maintaining quality standards throughout – right from preparation to generating, and finally, approving of new or revised packaging batch records and batch packaging orders.
Process XE packaging batch records or PBR, is designed to handle typical scenario in pharmaceuticals manufacturing industry where packaging process workflow is similar amongst many products in the same department, but only specific product parameters are different.
It means that for similar type of packaging for all products, there is one re-usable template which contains all common parameters and the second part of template remains specific to the product.
Process XE packaging batch records or PBR accommodates above efficiency enhancing feature, there-by allowing easy manageability of the master batch packaging records. Also, when version of template containing common parameters changes; it will simultaneously impact all products which uses those templates.
Process XE-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.
The system capabilities include:
- Each MBPR (Master Batch Packaging Record) is divided into two parts; Part A which is common or generic and part B which is product specific.
- When MBPR is released for execution, both parts are merged and released.
- Version Control of master batch records to enforce compliance
- Auto Alerts based on exceptions and validation rules
- Comprehensive Audit trails and Deviation Reports
- Custom Reports and Trending Analyses
- Printable PDF of Blank MBPR available