As pharmaceutical and biopharmaceutical manufacturing environments become more automated, digital batch records (DBRs)-often implemented as Electronic Batch Records (EBRs) or Manufacturing Batch Records (MBRs)-are replacing traditional paper documentation.
This transition is not simply a technological upgrade; it represents a fundamental shift in how product quality, data integrity, and manufacturing control are managed. The webinar Digital Batch Records provides practical guidance on how to design, validate, and manage digital batch execution systems in a way that reduces operational burden, improves compliance, and accelerates batch release.
The session begins by examining how paper-driven processes hinder modern GMP manufacturing. Paper batch records frequently lead to missing signatures, illegible entries, transcription mistakes, calculation errors, excessive deviations, and production delays caused by human error. By contrast, digital batch records enable real-time data capture, automated calculations, controlled material movements, and step-by-step operator guidance. However, many companies struggle because they attempt to recreate their paper batch logic exactly in electronic format, resulting in over-complicated workflows, duplicated approvals, and rigid systems that frustrate operators and slow implementation.
To address this, the webinar explains how to design digital workflows based on value and regulatory need, not on legacy paperwork. Participants learn how to incorporate interlocks, prompts, conditional logic, and equipment integration to prevent errors at the source instead of documenting checks after the fact. Examples include real-time deviation triggers, automated time/temperature/weight capture, controlled execution sequences, and automated batch calculations. The focus is on creating smarter workflows-not digital versions of paper binders.
The training also clarifies regulatory expectations from FDA, EMA, and other authorities. Many compliance headaches result from misinterpreting 21 CFR Part 11 and EU Annex 11. Regulators do not require re-testing of vendor software features, duplicate signatures for every action, or piles of screenshots to prove execution. They expect identity, accuracy, traceability, and control over data that influence product quality and release decisions. The webinar highlights what auditors actually look for in digital batch systems, including role-based access control, clear intention within electronic signatures, meaningful use of audit trails, and real-time data integrity consistent with ALCOA+ principles.
Participants also learn how to right-size validation and documentation for DBR implementation. Instead of validating every feature of a vendor platform, the focus is on validating the configuration that supports intended use. The session provides strategies for leveraging supplier documentation, performing risk-based testing, and producing deliverables that reflect control-rather than stacks of redundant documents.
Finally, the webinar demonstrates how digital batch records support faster batch release, fewer investigations, and improved data integrity by shifting review activities from after-the-fact to real-time, exception-based oversight. Review-by-exception combined with automated checks and interlocks significantly decreases release cycle time and regulatory exposure while improving batch reliability.
Attendees leave with practical tools to simplify implementation, support compliance requirements, and modernize manufacturing execution. Rather than creating more work, digital batch records-when designed correctly-enable safer, faster, more efficient production.
Why should you Attend:
Digital batch records are rapidly replacing paper-driven manufacturing documentation across the pharmaceutical, biotech, and cell and gene therapy industries. This shift offers tremendous benefits-faster batch release, fewer deviations, real-time data integrity, and improved compliance-but only when implemented correctly. Many organizations struggle because they try to digitize paper processes without rethinking workflow design, resulting in complex systems, excessive approvals, and increased operator burden. This training equips students with the practical knowledge needed to avoid those pitfalls and implement digital batch records the right way.
Students will learn how to design efficient, compliant workflows that leverage the strengths of electronic systems rather than replicating manual controls. They will gain clarity on how to use interlocks, conditional logic, real-time checks, and automated data capture to prevent errors instead of documenting them after the fact. This approach not only improves product quality and traceability but also reduces investigations, deviations, and documentation errors that delay batch release.
The training also provides essential regulatory insight, helping students understand what FDA, EMA, and global authorities actually expect from digital batch records. The session dismantles costly myths-such as validating every system feature or requiring blanket duplicate signatures-and teaches how to produce right-sized, audit-ready documentation that demonstrates control without burdening the organization.
Whether a participant works in manufacturing, quality, validation, regulatory affairs, or digital transformation, this training will help them build systems that reduce operational stress, accelerate release cycles, and strengthen data integrity. Attendees will leave with actionable skills that make digital batch records easier, smarter, and more compliant.
Areas Covered in the Session:
