1What a batch record must contain, on paper or on screen.
The content of a batch record is set by the GMP rules, not by the medium. In the US, § 211.188 requires batch production and control records “for each batch of drug product produced”, with “complete information relating to the production and control of each batch”: an accurate, checked, dated and signed reproduction of the master production record, and documentation that each significant step was accomplished.¹ In the EU, Chapter 4 of the GMP Guide requires a batch processing record for each batch, based on the currently approved manufacturing formula and processing instructions.²
| What the record shows | 21 CFR 211.188(b) | EU GMP Chapter 4, 4.20 |
|---|---|---|
| When | Dates | Dates and times of start, significant intermediate stages and completion |
| Equipment | Identity of major equipment and lines | Major equipment used |
| Materials | Each batch of component or in-process material, with weights and measures | Batch number and quantity of each starting material weighed |
| Controls | In-process and laboratory control results; sampling | In-process controls, results and who did them |
| Yield | Actual yield and percentage of theoretical yield | Yield at pertinent stages |
| People | Who performed and who supervised or checked each significant step | Who performed each significant step and who checked it |
| Problems | Any investigation under § 211.192 | Notes on special problems, with signed authorisation for any deviation |
An electronic record has to capture all of this as the work is done. FDA says data generated to satisfy a CGMP requirement become a CGMP record and must be saved at the time of performance. Its example is that an electronic batch record system “can be designed to automatically save after each entry”, which is “similar to indelibly recording each entry contemporaneously on a paper batch record”.³
2Does FDA require an electronic batch record?
No. The drug CGMP regulations allow either medium. Section 211.68 permits “computers, or related systems that will perform a function satisfactorily” in manufacturing, provided changes to master production and control records are made only by authorised personnel, input and output are checked for accuracy, and backup data are kept exact, complete and secure.⁴
What changes when the record is electronic is that Part 11 applies. It covers records in electronic form created, modified, maintained, archived, retrieved or transmitted under FDA’s records requirements, and electronic records that meet it “may be used in lieu of paper records”.⁵ FDA’s 2003 guidance reads the scope narrowly: Part 11 applies when a required record is kept electronically in place of paper, or kept in both forms with the electronic record relied on. Printing a record and relying on the paper generally does not trigger it, and FDA recommends deciding in advance, and documenting, which form you rely on. Paper and electronic components can co-exist in a hybrid record as long as the predicate rules are met.⁶
Signatures are not an obstacle. Section 211.186(a) asks for a “full signature, handwritten” on master production and control records, but FDA says an electronic signature with appropriate controls to link it to the record fulfils that requirement, and can replace handwritten signatures or initials “in any CGMP required record”.³⁷
In the EU, Chapter 4 says documentation “may exist in a variety of forms, including paper-based, electronic or photographic media”, and that hybrid records need their relationships and controls stated.² Annex 11 applies to all computerised systems used in GMP-regulated activities.⁸
3What the system has to do.
The controls come from Part 11 and § 211.68 in the US, read with FDA’s data integrity guidance, and from Annex 11 in the EU.⁵⁴³⁸
| Expectation | US | EU |
|---|---|---|
| Validation | 11.10(a); each CGMP workflow validated for its intended use | Application validated, infrastructure qualified (Annex 11 principle, 4) |
| Audit trail | Secure, computer-generated, time-stamped audit trails (11.10(e)) | Risk-based audit trail of GMP-relevant changes and deletions, with reasons, regularly reviewed (Annex 11, 9) |
| Sequence and access | Operational checks enforce permitted sequencing; authority checks limit who can sign, alter records or operate (11.10(f), (g)) | Physical or logical controls restrict access to authorised persons (Annex 11, 12) |
| Data entry | Input and output checked for accuracy (211.68(b)) | Additional accuracy check for critical data entered manually (Annex 11, 6) |
| Signatures | Name, date and time and meaning shown; linked to the record (11.50, 11.70) | Same impact as handwritten, permanently linked, time and date included (Annex 11, 14) |
| Release | Quality control unit reviews and approves the records before release (211.192)⁹ | Only Qualified Persons can certify release, by electronic signature (Annex 11, 15) |
Validation has to reach the record itself, not only the software. FDA’s example is that qualifying a manufacturing execution system platform “does not demonstrate that a given MPCR generated by the MES contains the correct calculations”; validating the workflow does.³ Annex 11 adds that when a computerised system replaces a manual operation, “there should be no resultant decrease in product quality, process control or quality assurance”.⁸
FDA’s 2003 guidance says it intends to exercise enforcement discretion on Part 11’s specific requirements for validation and for computer-generated, time-stamped audit trails. The predicate rules still apply, including any requirement that changes to records do not obscure earlier entries, and FDA recommends basing validation on a justified and documented risk assessment.⁶ Its data integrity guidance still expects each CGMP workflow to be validated for its intended use and audit trails to be reviewed with the record.³
An electronic system can also take on a check. Under § 211.68(c), automated equipment can satisfy the requirement for one person to perform an operation and another to check it, if one person checks that the equipment performed the operation properly; § 211.188(b)(11) then records that person.⁴¹
4How an electronic batch record is reviewed.
The quality control unit must review and approve all production and control records before a batch is released, and thoroughly investigate any unexplained discrepancy or failure to meet specifications.⁹ For an eBR, the audit trail is part of that record. FDA says people responsible for record review should review the audit trails of changes to the data as they review the rest of the record, at the frequency the regulations set for the data, such as after each significant step under § 211.188(b) and before release.³
EU GMP allows review to focus on exceptions where the process supports it: “Where a validated process is continuously monitored and controlled, then automatically generated reports may be limited to compliance summaries and exception/ out-
5How it runs in Seal.
In Seal’s electronic batch records, the approved master record becomes an executable workflow that checks materials, equipment, training, limits and signatures as the work happens. A scanned container is checked for identity, status, expiry and eligibility before the step proceeds, an out-of-range value opens an exception from the step with its context, and each signature records the signer, time and meaning, with the option to require a verifier different from the performer. Batches in progress keep the master version they started with, and the audit history preserves original and changed values, reasons, users and times.
Review begins while the batch is running, so reviewers can focus on exceptions with the full record available. The MES keeps materials, equipment, QC and quality on the same platform as the batch, and for batch release, Neil reads each lot’s record, lab results and line log and leaves QA a short list of what needs a person. People decide and sign; Neil never releases a lot or changes the record.
References
- 121 CFR 211.188, Batch production and control records, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 188 (read 6 November 2026) - 2EudraLex Volume 4, EU GMP Guide Part I, Chapter 4: Documentation, sections 4.1, 4.11 and 4.20, European Commission, in operation from 30 June 2011. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ chapter4_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 3Data Integrity and Compliance With Drug CGMP, Questions and Answers, guidance for industry, FDA, December 2018, questions 3, 7, 8, 11 and 12. https:/
/ www. fda. gov/ media/ 119267/ download (read 6 November 2026) - 421 CFR 211.68, Automatic, mechanical, and electronic equipment, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- D/ section- 211. 68 (read 6 November 2026) - 521 CFR Part 11, Electronic Records; Electronic Signatures, sections 11.1, 11.10, 11.50 and 11.70, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- A/ part- 11 (read 6 November 2026) - 6Guidance for Industry: Part 11, Electronic Records; Electronic Signatures, Scope and Application, FDA, August 2003. https:/
/ www. fda. gov/ media/ 75414/ download (read 6 November 2026) - 721 CFR 211.186, Master production and control records, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 186 (read 6 November 2026) - 8EudraLex Volume 4, Annex 11: Computerised Systems, European Commission, in operation from 30 June 2011. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ annex11_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 921 CFR 211.192, Production record review, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 192 (read 6 November 2026) - 1021 CFR 211.180, General requirements (records and reports), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 180 (read 6 November 2026)
AQuestions and answers
Is an electronic batch record the same as an MES?
Not quite. The eBR is the batch record itself; a manufacturing execution system (MES) is one kind of system that can create and execute it. FDA’s data integrity guidance makes the point that qualifying an MES platform does not show that a given master record built in it is correct, so each workflow is validated for its intended use.
Can electronic signatures replace handwritten signatures on master batch records?
Yes. FDA says an electronic signature with appropriate controls, securely linked to its record, fulfils the “full signature, handwritten” requirement in 21 CFR 211.186(a). Part 11 sets the conditions under which electronic signatures are the legally binding equivalent of handwritten ones.
Does Part 11 apply if we print the electronic batch record?
It depends on which record you rely on. If the printout meets all the predicate rule requirements and people rely on the paper, FDA generally does not consider Part 11 triggered. If you rely on the electronic record to do regulated work, it does. FDA recommends deciding this in advance for each record and documenting it.
Does an electronic batch record need an audit trail?
In practice, yes. Part 11 requires secure, time-stamped audit trails for closed systems, and EU Annex 11 asks for a risk-based audit trail of GMP-relevant changes and deletions, with reasons. FDA has said it will use enforcement discretion on Part 11’s audit trail requirement, but changes must still not obscure earlier entries, and FDA expects reviewers to read the audit trail as part of the batch record review before release.
How long must electronic batch records be kept?
The same as paper. In the US, at least one year after the batch’s expiry date, or three years after distribution for certain OTC products without expiry dating. In the EU, at least one year after expiry or five years after QP certification, whichever is longer. The record must stay retrievable and readable for the whole period.