Electronic Batch Record (EBR) Software – MasterControl

What is Electronic Batch Records (EBR) Software?

Guarantee adherence and enhance effectiveness by integrating an Electronic Batch Record (EBR) system to automate your existing paper-based processes.

• The FDA's Current Good Manufacturing Practices (CGMPs) necessitate proof of proper handling at all production stages.
• Batch records and various manufacturing documents serve as evidence of accountability.
• Traditional paper-based systems are problematic and prone to errors.
• Electronic batch record (EBR) software alleviates documentation workload for quality and manufacturing teams.
• EBR enhances product quality and key performance indicators.

Why Electronic Batch Records (EBR) Software?

Benefits of an EBR Software System

• Adhere to regulations easily

  • EBR (Electronic Batch Record) must showcase completion of all significant stages under 21 CFR Parts 210-211 regulations.
  • Inclusive of production, packaging, and storage steps for every drug product batch.
  • Employing an appropriate solution ensures compliance with FDA's CGMPs and regulatory demands.

• Track and manage production data

  • Electronic batch records simplify production data tracking and management.
  • Paper-based processes can lead to challenges in routing forms accurately and in sequence.
  • EBR software resolves such issues by eliminating manual routing problems.
  • The software contributes to maintaining data integrity and saving time.
  • EBR software also ensures compliance with regulations.

• Avoid frequent mistakes

  • Paper-based batch records pose problems
  • Frequent issues: illegible entries, documentation errors
  • Accidental duplication of efforts occurs
  • Result: significant production delays
  • Need to transition away from paper-based system
  • Emphasize: developing quality products, faster market delivery

• Operate from a single source of truth

  • Paper-based system lacks certainty about the latest batch record.
  • Only one person can review documents at a time in paper-based system.
  • Finding and accessing documents is cumbersome in paper-based system.
  • EBR software stores accurate data centrally.
  • Data in EBR software can be accessed by authorized individuals anytime, anywhere.

• The Competitive Advantage of Going Paperless with an EBR software

  • Extensive EBR systems documentation is mandated by CGMPs.
  • Documentation should encompass batch dates.
  • Identity of major equipment/lines used must be recorded.
  • Components/materials used, along with their weights and measures, should be documented.
  • In-process and laboratory control results are essential parts of the documentation.
  • Comprehensive labeling control records are required.
  • Sampling details need to be included.
  • Personnel responsible for supervising or checking each step must be identified.

• Comply With 21 CFR 210-211

  • Traditional use of paper for production batch records by pharmaceutical companies
  • Introduction of 21 CFR Part 11 in 1997 allowed FDA acceptance of Electronic Batch Record (EBR) systems
  • Adoption of EBR software requires compliance with 21 CFR Parts 210-211 regulations
  • Regulatory requirements encompass time-stamped audit trail, reporting, electronic signature, and security measures

Electronic Batch Records (EBR) Software Dealer/Reseller

Factonity Systems Pvt Ltd is a full service dealer & reseller of Electronic Batch Records (EBR) Software. Apart from software licensing, we also provide authentic software training, local technical support and statistical consulting.

Please contact us for:

• Latest Electronic Batch Records (EBR) Software pricing information / quotation
• Demo of Electronic Batch Records (EBR) Software and free initial consultation
• Lean Six Sigma + Electronic Batch Records (EBR) Software bundled training with licensed of demo software
• Post sales local technical support

Who uses Electronic Batch Records (EBR) Software?

MasterControl assists global companies in automating their batch record processes to fulfill regulatory demands.

Which industries use Electronic Batch Records (EBR) Software?

Leading corporations utilize Electronic Batch Records (EBR) Software. Below are a few industries that leverage the capabilities of Electronic Batch Records (EBR) Software: