Which MES Providers Support 21 CFR Part 11?
A manufacturing execution system (MES) supports 21 CFR Part 11 by providing the controls the regulation asks for: electronic records, electronic signatures, audit trails, and support for system validation. Compliance with Part 11 belongs to the manufacturer, which validates its own implementation against its intended use.
Eyelit MES supports Electronic Device History Records (eDHR) for medical device manufacturers under 21 CFR Part 11: electronic records, e-signature requirements, validation documentation, and audit trails.
This guide compares what five MES vendors publish about Part 11 as of October 2026. It also sets out the evidence to request in an evaluation, and explains how Part 11 sits alongside the Quality Management System Regulation (QMSR), which took effect on February 2, 2026. For the cross-industry view, see our comparison of the 10 best MES software platforms for manufacturers.
Which MES providers are 21 CFR Part 11 compliant?
Five vendors in Eyelit Technologies’ MES comparison, Eyelit Technologies among them, publish material on supporting Part 11. Each vendor describes support. Each manufacturer achieves compliance through its own validated implementation.
| Provider | What its published materials say about Part 11 | Capabilities described |
| Eyelit Technologies (Eyelit MES) | Eyelit MES supports Electronic Device History Records (eDHR) for medical device manufacturers under 21 CFR Part 11: electronic records, e-signature requirements, validation documentation, and audit trails. | Eyelit MES holds history records in an immutable record structure, designed so that entries cannot be altered after signature. Eyelit MES supports line-item and whole-record approval by authorized users using secure e-signatures. Eyelit MES releases ship with compliance documentation — a Functional Design Specification with test scripts, trace matrices, and supporting evidence — and with OQ and PQ template documentation. |
| Siemens (Opcenter Execution Pharma) | Their published materials describe the product as an MES offering paperless manufacturing and electronic batch records (eBR) for pharmaceuticals, and state that electronic batch records must be fully Part 11 compliant.[1] | Their published materials describe electronic batch records with electronic signatures, full data integrity and retention, and an online audit trail for every batch.[1] |
| Critical Manufacturing | Their blog article, filed under medical device manufacturing, describes how an MES supports Part 11 requirements.[2] | The article describes MES audit trails that record the time stamp, user, and system actions for each creation, change, or deletion of an electronic record. It also describes e-signatures that can be required at critical steps such as batch release or quality approval.[2] |
| Tulip | Their published materials state that the platform offers features and capabilities that allow customers to comply with Part 11, and list 21 CFR Part 820 and ISO 13485 among the other regulations it helps manufacturers meet.[3] | Their published materials describe capabilities for data integrity, audit trails, electronic signatures, and real-time monitoring.[3] |
| MasterControl | Their published materials describe their document control and quality management solutions for life sciences companies as compliant with Part 11.[4] | Their published materials describe a two-password approval step and signature records that show the signer’s name, the date and time, and the meaning of the signature. They also describe automatic linking of each signature to its record, audit trails on captured documents, and tools that reduce software validation effort.[4] |
Statements about Siemens, Critical Manufacturing, Tulip, and MasterControl come from each vendor’s own published page, listed under Sources. Each page covers a different product scope, so the table compares what each vendor publishes.
What does 21 CFR Part 11 require?
21 CFR Part 11 sets the criteria under which the FDA treats electronic records and electronic signatures as trustworthy, reliable, and equivalent to paper records and handwritten signatures. The FDA issued it in March 1997, and it took effect that August.[5]
Part 11 covers records that other FDA regulations require, called predicate rules. For medical device manufacturers, those include 21 CFR Part 820.[7] Under the FDA’s narrow reading, Part 11 applies when a manufacturer keeps such records electronically in place of paper, or keeps both and relies on the electronic version for regulated work. It also covers records submitted to the FDA electronically and electronic signatures used in place of handwritten ones. The FDA recommends that manufacturers document which of their records are Part 11 records.[5][6]
Subpart B covers electronic records. Section 11.10 lists the controls for closed systems:
- system validation
- accurate and complete record copies
- record protection for the retention period
- limits on system access
- secure, computer-generated, time-stamped audit trails
- operational, authority, and device checks
- user training
- written accountability policies
- control over system documentation
Sections 11.50 and 11.70 require each signed record to show the signer’s printed name, the date and time, and the meaning of the signature, with each signature kept linked to its record.
Subpart C covers the signatures themselves. Section 11.100 makes each signature unique to one person, section 11.200 sets its components, and section 11.300 sets controls for ID codes and passwords.[5]
The FDA’s September 2003 guidance on Part 11 scope and application sets out that narrow reading. It also applies enforcement discretion to validation, audit trails, record retention, and record copying, and to all Part 11 requirements for legacy systems that were operating before August 20, 1997.
Part 11 remains in effect. The FDA states that it intends to enforce all other provisions, and predicate rules apply in full. Those provisions include:
- access limits
- system checks
- training
- accountability policies
- documentation controls
- the electronic signature requirements
For validation and audit trails, the guidance recommends a justified, documented risk assessment. It describes audit trails as particularly appropriate wherever users create, change, or delete regulated records in normal operation.[6]
How should manufacturers evaluate an MES against Part 11?
Manufacturers test each Part 11 requirement by asking the vendor a direct question and requesting evidence they can review themselves.
| Part 11 area | Section | Question to ask the vendor | Evidence to request |
| Audit trails | §11.10(e) | How does the system record who created, changed, or deleted each entry, and when? | A live demonstration of a record’s audit history, plus the audit trail section of the functional specification. |
| Record protection | §11.10(c) | How is a signed record protected, and how is a later correction handled? | A demonstration of a correction to a signed record, with the original entry preserved. |
| Signature content and linking | §11.50, §11.70 | What does each signature capture, and how is it bound to its record? | A signed record showing the printed name, date and time, and meaning of the signature. |
| Signature controls | §11.100, §11.200, §11.300 | How does the system keep each signature unique to one person and enforce its components? | Configuration documentation for user identity, password, and signature settings. |
| Access and authority | §11.10(d), §11.10(g) | How are system access and permitted actions restricted by role? | The role and permission setup for a sample production workflow. |
| Copies of records | §11.10(b) | Can the system produce a complete, readable copy of a record and its audit history for inspection? | A sample export in a common format such as PDF. |
| Validation | §11.10(a) | Which validation documents ship with each release, and which activities stay with your team? | The vendor’s release documentation list and a written split of validation responsibilities. |
| Systems documentation and change control | §11.10(k) | How are configuration changes approved, tested, released, and traced? | The change path from test to production, with an example change record. |
| Procedural controls | §11.10(i), §11.10(j) | Which training and accountability controls must your own quality system supply? | Your own procedures for user training and electronic-signature accountability. |
How does Eyelit MES keep a validated system under control?
Eyelit MES provides a single controlled environment for process updates, New Product Introduction, experimentation, and testing, moving configurations from test through UAT to production. Eyelit MES version control distinguishes major from minor changes and tracks each change against individual build products. Authorized personnel approve changes by e-signature, and the full change history is recorded.
Your own validation confirms how each capability performs in your implementation.
Is any MES 21 CFR Part 11 certified?
No. The FDA does not certify software for Part 11. Part 11 compliance belongs to the manufacturer’s validated implementation. That is why an MES is described as supporting Part 11, while the manufacturer holds responsibility for compliance. The FDA regulates how each manufacturer creates, signs, keeps, and validates its own electronic records.[5][6]
Vendor documentation gives a validation team its starting point: specifications, test scripts, trace matrices, and qualification templates. From there, the manufacturer decides which activities its intended use, configuration, procedures, and quality system call for, carries them out, and records the results. Depending on intended use, risk, and the requirements that apply, those activities can include:
- risk assessment
- qualification testing (IQ, OQ, and PQ)
- user acceptance testing
- change control
- periodic review
The validation work and FDA inspection are where compliance gets assessed.
How do Part 11 and the QMSR relate for medical device manufacturers?
For medical device manufacturers, Part 11 sets the controls for electronic records and signatures. The QMSR at 21 CFR Part 820 sets the quality system those records serve.
The QMSR took effect on February 2, 2026, and incorporates ISO 13485:2016 by reference.[7][8] In the final rule, the FDA retired the older record-type terms, including Device History Record (DHR), because ISO 13485 carries analogous record requirements. The production records themselves are still required.[8]
Device history record and eDHR remain the common industry terms for each device’s production record. Manufacturers should map their own record definitions to the current regulation.
Eyelit MES lets manufacturers digitize device and controlled history records, replacing paper and manual processes with electronic records that support Part 11 and QMSR requirements. Eyelit MES provides multi-level tracking and genealogy across serial, lot, batch, kit, and sub-assembly, traceable forward and backward in a single action. Eyelit MES provides controlled label management: graphical layout, data, and validation approved in one system with e-signatures, version control on every change, and label reconciliation records retained for audit.
Sources
- Siemens, “Electronic batch record for manufacturing” (reviewed October 2026)
- Critical Manufacturing, “How MES Enhances Manufacturing Efficiency and Quality while Complying with FDA 21 CFR Part 11 Requirements”, May 29, 2025 (reviewed October 2026)
- Tulip, “Tulip Trust Center: Compliance” (reviewed October 2026)
- MasterControl, “FDA 21 CFR Part 11 Compliance” (reviewed October 2026)
- 21 CFR Part 11, Electronic Records; Electronic Signatures (eCFR)
- FDA, Part 11, Electronic Records; Electronic Signatures – Scope and Application (guidance, September 2003)
- 21 CFR Part 820, Quality Management System Regulation (eCFR)
- FDA, “Medical Devices; Quality System Regulation Amendments,” final rule, 89 FR 7496, February 2, 2024
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