Electronic Batch Record Management
Batch records are critical in pharma manufacturing, proving a batch followed GMP and the master record. Paper records risk errors, illegible entries, missing signatures, and records without labels.
Master Batch Record Design and Version Control
Structured MBR template authoring
Master batch records are created in the EBR system with steps, controls, signatures, and equipment links, then versioned, approved, and released through a controlled workflow.
Version control and supersession management
MBR versions are tracked with full revision history, previous versions are archived for review, while only the current approved version is used for new batch execution.
Change control integration
MBR changes are managed via your change control system, including impact assessment, approval routing, and post-change verification before release to production.
Step-by-Step Batch Execution
Enforced sequential execution
Each batch step must be confirmed before the next opens, preventing out-of-sequence work and enforcing holds that would trigger deviation reports.
Mandatory in-process control capture
In-process control checks appear as mandatory EBR steps at set frequencies, with automatic limit checks and instant OOS alerts when results fall outside MBR specifications.
Electronic operator and supervisor confirmations
Critical steps need operator confirmation and supervisory countersignature, capturing both identities, timestamps, and the purpose of each signature in the batch record.
21 CFR Part 11 and EU Annex 11 Compliance
Tamper-evident audit trail for all data
All data entries, edits, exceptions, and approvals are logged in a tamper-evident audit trail with user, timestamp, and reason.
Role-based access and unique user accounts
Each EBR user has unique credentials with role-based access: operators execute, QA reviewers approve, and admins configure enforcing system-level access boundaries.
Computer system validation documentation
Webstrail provides a full GAMP 5 validation documentation plan, FS/DS, IQ/OQ/PQ protocols, traceability matrix, and summary, lightening the validation load for quality and IT teams.