21 CFR Part 11
Electronic records & signatures
Signing re-authenticates the user. Each signature shows printed name, date and time with time zone, and its meaning, and is bound to the record. The audit trail is always on and cannot be edited.
Corpex-EBR · Electronic Batch Record
Electronic batch records that enforce the recipe, not just store it.
Corpex-EBR is electronic batch record software for pharmaceutical manufacturers. It runs the master batch record on the shop floor, enforces sequence and limits while the batch runs, collects electronic signatures, and hands QA and the Qualified Person a record that is ready to review by exception.
- Stage 1Created
- Stage 2Released to line
- Stage 3In progress
- Stage 4Execution complete
- Stage 5In review
- Stage 6QA approved
- Stage 7Closed
Every batch follows these seven states. A batch can also be put on hold, rejected back to production or aborted, and nothing is ever deleted.
- 43
- Step typesIn 7 families
- 10
- Batch statesCreated to closed
- 24
- Exception rulesChecked on every batch
- 7
- Step statesNot started to voided
End to End
From Master Batch Record to QP Release
An eBMR is only as good as the path a batch takes through it. Each step hands the same record to the next, so nothing is retyped and nothing is skipped.
- Master batch recordAuthor
- ApproveAuthor ≠ checker
- Create batchFrozen snapshot
- Dispense & weighLot checks
- Execute & signStep signatures
- ExceptionsDeviations
- ReviewBy exception
- ReleaseQA · QP
The Screens
Nine Areas, Shown in the Real Application
Pick an area to see its screen. Every screenshot is taken from Corpex-EBR running on demo data.
01 / 09
Master batch records
Author the recipe once, approve it, and every batch runs on a frozen copy.
- Step library of 43 step types in 7 families, from line clearance to dispensing and yield
- Recipe checks run automatically; a draft that fails them cannot go to review or approval
- Author and checker must be different people
- An approved version is read-only; a change creates a new version
02 / 09
Batch execution
The operator sees one step at a time, with the signature the step needs.
- Sequence is enforced by the server, not just the screen
- Each step carries its signature policy: performer alone, or performer and verifier
- Line clearance runs a fixed set of twelve checks with an independent verifier
- A repeated step creates a new record; the earlier one stays visible
03 / 09
Dispensing
Weigh against the target, and see where every kilogram went.
- Dispensing refuses a lot that is expired, in quarantine or not released
- Containers are scanned by GS1 code; dispense labels are printed and recorded
- Mass balance reconciles dispensed quantity against consumed, returned and waste
- A variance that does not reconcile is flagged before the batch can be released
04 / 09
Exceptions
Findings are raised while the batch runs, then handled by a person.
- 24 exception rules cover limits, sequence, late entry, missing signatures, yield, alarms and more
- Each finding is graded critical, major or minor and can be acknowledged, justified, escalated or closed
- A deviation can be raised from the batch with an investigation plan and an optional eQMS reference
- Open deviations block release until they are dispositioned
05 / 09
Disposition and release
One gate lists everything that must be true before QA releases.
- The gate checks exceptions, deviations, signatures, laboratory results, OOS or OOT investigations, execution and audit-trail review
- Choose the full-review path or, where permitted, review by exception
- Every disposition is recorded with the verdict, reason, market and decider
06 / 09
QP certification
Certification follows release, and only a Qualified Person can sign it.
- Limited to the Qualified Person role, with the certifying person recorded
- The QP records the market, a registration reference and a declaration
- Refused until QA has released the batch
- Built around the batch-certification step in EU GMP Annex 16
07 / 09
Print and export
The dynamic record stays the original. The PDF is a labelled copy.
- PDF/A-3b batch record with the audit trail included on request
- Labelled a true copy once the batch is approved or closed, and an uncontrolled copy before that
- Every print and download is recorded with a reason
- Certificate of analysis and certificate of compliance issued from the released record
08 / 09
Production board
See every batch in flight, by area, line and shift.
- Batches grouped by area, with progress and open deviations at a glance
- Open any batch straight from the board to see its ticket
- Dashboard of release gate status across batches
09 / 09
Analytics
Quality and process performance from the live batch record.
- Operations view: right-first-time, release cycle, execution cycle, yield and throughput
- Process capability, batch comparison and multivariate views
- Deviation trending by type, and an APQR view
Electronic signatures
Every signature proves who you are, again
Signing does not inherit the login. The operator picks the meaning of the signature from the list the step allows, is taken to the sign-in page to prove identity, and the signature is bound to the record. If any signed content changes afterwards, the record shows as tampered.
- Meaning comes from a controlled list, and cannot be typed or altered later.
- The verifier cannot sign before the performer, and cannot be the same person.
- A signature is never silently attributed to someone else.
Corrections
A correction never overwrites the value it corrects
Mistakes happen on the shop floor. In Corpex-EBR the corrected value supersedes the earlier one with a reason, and both stay in the record, so the reviewer sees the original, the correction and who made it.
- Values show as in specification, alert or out of specification against their limits.
- Superseded entries are kept and print as changed.
- An out-of-specification entry raises an exception and, where configured, a deviation.
Release gate
See what is still open before anyone is asked to sign
Release is not a button anyone can press. The gate lists each condition and whether it is satisfied. While exceptions, deviations, missing signatures or laboratory results are open, the gate stays shut and says why.
- Open exceptions, blocking exceptions and open deviations.
- Missing signatures and laboratory blockers, including OOS or OOT investigations.
- Batch execution and audit-trail review.
Inspection Ready
What an Inspector Asks of a Batch Record
Can you show the recipe this batch ran?
Each batch holds a frozen copy of the approved master version it was created from, with its content hash.
Who performed and who verified?
Performer and verifier are different people, in sequence, and every signature prints with name, date, time zone and meaning.
What changed, and why?
A correction supersedes the earlier value with a reason. The original entry stays in the record and prints as changed.
What was out of limits, and what was done?
Exceptions are raised as they happen, graded, and linked to a deviation where one is needed.
Was the record reviewed independently before release?
The audit-trail reviewer is refused if they took part in the activities under review. The release gate shows what is still open.
Can you hand me the whole record?
A PDF/A-3b copy with the audit trail, labelled as a true copy, and carrying the identifier and hash of its source record.
Compliance
The Rules an EBR Is Judged Against
Each card names the control in Corpex-EBR that answers the requirement.
EU GMP Annex 11
Computerised systems
Role-based access enforced on the server, a hash-chained audit trail, time taken from the server rather than the client, and checks on accuracy at critical entry.
21 CFR 211.186
Master production record
Master records are approved with author and checker as different people, and an approved version cannot be edited. A change creates a new version.
21 CFR 211.188
Batch production record
Each batch embeds the exact master version it started from and records every step with the person and the time.
21 CFR 211.192
Production record review
The release gate holds a batch until exceptions, deviations and missing signatures are dealt with and the audit trail has been reviewed.
EU GMP Chapter 4
Documentation
A controlled recipe, a complete record that cannot be overwritten, and a review-by-exception path that follows the conditions Chapter 4 sets.
EU GMP Annex 16
Certification by a Qualified Person
QP certification is its own step after QA release, limited to the QP role, with market, reference and declaration recorded.
ALCOA+
Data integrity
Entries are attributable, time-stamped on the server and kept in original form. Corrections add a new entry and leave the old one in place.
Compliance belongs to the validated system and the procedures around it. Corpex-EBR supplies the technical controls, and the Corpex validation team documents them for your inspection, using a risk-based approach in line with GAMP 5. See computer system validation.
Electronic Batch Record Software
An EBR for Pharma Manufacturers, Built for Review by Exception
A paper batch record is read page by page after the batch is finished. Corpex-EBR moves the checking into the batch itself, so the reviewer starts from a short list of findings. It works alongside CORPEX-ERP, CORPEX LIMS and CORPEX-eQMS, and is validated like any other GxP computerized system through computer system validation (CSV).
Recipes as controlled configuration
Master batch records are versioned and approved. A new version never changes a batch already running on the old one.
Interfaces to your other systems
Defined interfaces for ERP production orders and consumption, LIMS samples and results, and label printers.
Implemented with you
Configuration, training and validation delivered by the Corpex team, then supported after go-live.
See a Batch Go From Recipe to QP Release
Book a demo and we will walk one batch through dispensing, execution with signatures, exceptions and release with you.
Request a DemoFrequently Asked Questions About Electronic Batch Records
What is an electronic batch record (EBR)?
An electronic batch record is the batch manufacturing record kept as data instead of paper. The approved recipe tells the operator what to do, each step is recorded as it happens with the person and the time, and the system refuses out-of-sequence work. It is also called an eBMR (electronic batch manufacturing record).
How is an EBR different from a paper batch record?
A paper record is checked after the batch has run. In Corpex-EBR the recipe is enforced while the batch runs: a step cannot start before its prerequisites, values are checked against limits as they are entered, and out-of-limit results raise an exception on the spot instead of being found at review.
What is review by exception?
Reviewers do not re-read every entry. The system lists only the findings that need a person: out-of-limit values, bypassed controls, missing signatures, late entries, open deviations. In Corpex-EBR the review-by-exception path is available only when the market configuration permits it and the process is flagged as validated and continuously monitored. Otherwise the reviewer follows the full-review path.
Does Corpex-EBR support 21 CFR Part 11 and EU GMP Annex 11?
It provides the technical controls those rules call for: unique user accounts, role-based access, a time-stamped audit trail that cannot be switched off or edited, and electronic signatures that re-authenticate the signer and show printed name, date and time with time zone, and the meaning of the signature. Compliance belongs to the validated system and your procedures; the Corpex team documents the controls for your inspection.
Can a Qualified Person certify batches in Corpex-EBR?
Yes. QP certification is a separate step that follows QA release and is limited to the Qualified Person role. The QP records the market, an optional registration reference and a declaration. Certification is refused until the batch has been released.
What does an EBR connect to?
Corpex-EBR has defined interfaces for ERP production orders and material consumption, LIMS samples and results, and label printers. A deviation raised on the shop floor can carry a reference to your eQMS record. See also Corpex-ERP, Corpex LIMS and Corpex-eQMS.
How is Corpex-EBR validated?
Corpex-EBR comes with validation documentation written around GAMP 5: a validation plan, a risk assessment method and qualification protocols. The Corpex validation team carries out the validation with you; see our computer system validation services.
Can operators keep working if the network drops?
Yes. Entries made offline are held on the device and sent when the connection returns. They carry the capture time evidence and are flagged as offline in the batch record, the PDF and the audit trail. A sync conflict is never resolved silently; it goes to a person.