Electronic Batch Records (EBR or EBMR)

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.

MPCR Management

Process XE, an electronic batch record (EBR) software or electronic batch manufacturing record (EBMR) is a web based solution which automates the process of preparing, releasing and controlling various manufacturing documents.

Process XE, an electronic batch record (EBR) software helps produce and organize master production control records (MPCR) which contains work instructions, process steps, in-process data capture fields, SOPs to be used, material list for raw materials and expedients. This Smart Manufacturing software solution helps in releasing correct MPCR and captures all execution time values in  batch production control records (BPCR). 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.

In fast changing digital economy, people, systems and machines are interconnected and best implementations optimize use of this interconnectivity to produce expected results.

The use of manual or hybrid system results in consuming large amount of time, effort, and space to maintain. 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 digitalize and automate their business processes to address the above-mentioned obstacles.

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:

  • Defining Process model and Physical model
  • Efficient master batch records creation with re-usable building blocks or templates
  • Version control of master batch records to enforce compliance
  • Auto Alerts based on exceptions and validation rules
  • Defining and monitoring Product Specific CPP (Critical Process Parameter) ranges
  • Authorization available on fields and Process control for better compliance
  • Auto calculations on field values
  • Auto capture of process control system outputs into specific recipe elements or fields
  • Comprehensive Audit trails and Deviation reports
  • Custom Reports and Trending Analyses
  • PDF of Blank MPCR for partner review and executed BPCR
eBMR System Flow