Electronic batch record software: five systems read against the batch record rules

The executed batch production and control record kept in software: generated from the approved master, filled in step by step on the floor, signed by the people who did and checked each step, and reviewed by quality before release. For a drug maker its content is set by § 211.188. Because a predicate rule requires it and it is kept electronically, Part 11 applies to it (§ 11.1(b)); the Part 11 requirements, section by section are the controls it has to meet.

No, though they are usually sold together. A manufacturing execution system runs the floor (orders, equipment, materials, weigh and dispense); the batch record is the signed evidence it produces. Every product on this page is sold as an MES with the batch record as one function, so ask which modules your licence and your validation actually cover.

Yes. FDA's 2018 data integrity Q&A says “electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record”, and it names § 211.186(a), the “full signature, handwritten” line, as one of them. The appropriate controls are Part 11's signature sections.

Not for the operation itself. Under § 211.68(c), automated equipment can satisfy the one-person-does, another-checks requirements of §§ 211.101(c) and (d), 211.103, 211.182 and 211.188(b)(11) “if such equipment is used in conformity with this section, and one person checks that the equipment properly performed the operation”. So one signature stays, and the equipment has to be calibrated and checked under a written program (§ 211.68(a)).

The regulation does not use the term. § 211.192 has the quality control unit review and approve all production and control records before release, and FDA's 2018 Q&A puts the audit trail inside that review. Reviewing by exception is a way of doing that review, not of skipping it, and it holds only if the exception report has been tested to catch what it claims.

The QMSR took effect on February 2, 2026 and dropped the term. FDA says “many of the requirements previously in the DHR are largely required to be in the medical device or batch record, as described in Clause 7.5.1” of ISO 13485, and § 820.35(c) still requires the UDI for each device or batch. Part 11 still applies: the QMSR supplements FDA's other regulations (§ 820.1(b)). The QMSR guide for small device makers covers the rest of the change.

The parts you use, to the depth their risk calls for. For device makers, FDA's computer software assurance guidance covers software used in production and the quality system, and sorts features into “high process risk” and not. FDA wrote it for device makers; drug makers often borrow its risk ideas. The CSA validation scope planner sizes it per feature, and computer system validation for small labs covers the lifecycle.

No. FDA keeps no list of certified or approved Part 11 software. Part 11 binds the people who use a system, and its only certification is the letter a company sends FDA about its own electronic signatures (§ 11.100(c)).

For a US drug batch, at least one year after the batch's expiration date (§ 211.180(a)). EU GMP Chapter 4.11 asks for one year after expiry or at least five years after the Qualified Person certifies the batch, whichever is longer. Part 11 sets no period of its own; the audit trail is kept as long as the record (§ 11.10(e)).