Part 11 compliant CAPA software: seven vendors read against the CAPA record
Published , reviewed
Verdict
- Best overall
- TrackWise DigitalIt runs quality events, deviations and CAPA in one system, and its own Part 11 and Annex 11 assessment (dated March 2019) describes all nine rows on this page, down to old and new values in the trail and a password at each signing.
- Best for a small lab
- QualioCustomers receive a validation pack with test scripts and a Part 11 assessment, audit trail records are kept for the lifetime of the system, and the signature is the user's email plus a Qualio password, SSO users included.
- Best for a device maker
- Veeva QMSVeeva names device companies among those it fits, and complaints and CAPAs run in the same application, the pairing a device maker's complaint-driven CAPA needs. Each eSignature is a read-only record holding the signer's name, title, date and time and chosen meaning, pointing to the record that was signed.
Fig. 01A CAPA file is where an inspector reads how a quality team thinks: what went wrong, why, what was done and whether it worked. Kept in software, it is a Part 11 record, because a predicate rule requires it (ISO 13485 under the QMSR for device makers, the investigation record of § 211.192 for drug makers) and the approvals on it stand in for handwritten signatures.
This page reads seven quality systems with a CAPA module against the 9 Part 11 rows a CAPA leans on. The CAPA-specific controls our register cannot rate (a signed effectiveness check, linked deviations, a trail on root-cause edits) close the page as a demo script. For the wider suite, see the Part 11 eQMS comparison; for the record that usually opens a CAPA, the deviation management comparison.
What the rules ask of a CAPA record
Part 11 adds controls to a record; it never says which records you must keep. For a CAPA, that comes from the predicate rule, and device and drug makers read different ones.
Scroll sideways for both columns
| CAPA element | Device maker (QMSR, 21 CFR 820) | Drug maker (21 CFR 211) |
|---|---|---|
| Where the duty sits | The QMSR incorporates ISO 13485:2016 by reference: corrective action is Clause 8.5.2, preventive action Clause 8.5.3. The QS regulation's own CAPA section, § 820.100, was removed when the QMSR took effect on February 2, 2026. | Part 211 has no section called CAPA. The duty is built from § 211.192 (investigate discrepancies and failures), § 211.100(b) (deviations recorded and justified) and § 211.198 (complaints). FDA's ICH Q10 guidance describes a CAPA system as a recommendation. |
| What opens one | Nonconformities and complaints. FDA points to Clauses 8.2.2, 8.3.1 and 8.5.2 for investigating them and deciding whether action is needed so they do not recur. | “Any unexplained discrepancy” or a batch failing a specification, “whether or not the batch has already been distributed” § 211.192. Q10 adds complaints, rejections, recalls, deviations, audits, inspection findings and trends. |
| Investigation and root cause | The former § 820.100(a)(2) read “Investigating the cause of nonconformities”; the same work now sits under ISO 13485. The definitions of correction, corrective action and preventive action come from ISO 9000. | “Thoroughly investigated”, and the investigation “shall extend to other batches of the same drug product and other drug products that may have been associated” § 211.192. Q10: a structured approach aimed at the root cause. |
| How big the action is | FDA: “appropriate to the magnitude of the problem and commensurate with the risks encountered” (QMSR preamble). | Q10: effort, formality and documentation “commensurate with the level of risk”. |
| Effectiveness check | The former § 820.100(a)(4) asked for verifying or validating the action “to ensure that such action is effective”. FDA says adopting ISO 13485's definition of preventive action does not represent “a change in expectation”. | Q10, commercial manufacturing: “CAPA should be used, and the effectiveness of the actions should be evaluated.” |
| Approval | Where ISO 13485 says “approved”, FDA reads a signature and date, and accepts signatures that meet its electronic signature requirements. | The quality control unit reviews production records and checks that errors “have been fully investigated” § 211.22(a); it approves the records before release § 211.192. |
| The record that stays | Complaint records hold “Any correction or corrective action taken” § 820.35(a)(6), on top of record control in Clause 4.2.5. | “A written record of the investigation” with “the conclusions and followup” § 211.192. A complaint not investigated records the reason and “the name of the responsible person” § 211.198(b)(3). |
Two things follow for the software. A device maker's CAPA duty now lives in a standard FDA incorporates by reference, so the system has to carry the ISO 13485 process rather than the old § 820.100 checklist (our QMSR guide for small device makers covers the switch). A drug maker's CAPA hangs off an investigation, so the link from the deviation or complaint to the CAPA is part of the record, not a convenience.
Where Part 11 bites in a CAPA
FDA's 2003 guidance uses enforcement discretion on the Part 11 versions of validation, audit trail, copies and retention, but says it intends to enforce the signature sections in full, and every predicate rule. On a CAPA that puts the weight on two signatures with two different meanings: the approval of the plan and the verification that it worked.
The trail still bites, through the predicate rule. The same guidance calls audit trails “particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation”, which is what a CAPA owner does all week. Switch the last column between the two rule sets.
Scroll sideways for all columns
| Stage | The record and the signature meaning | What Part 11 asks | The rule behind it: device maker |
|---|---|---|---|
| 01Open and classify | Source event (deviation, complaint, audit finding), owner, risk classMeaning: None yet; a signed decision if no investigation is opened | Only authorised people open or classify § 11.10(g); the creation is trailed § 11.10(e) | Complaint handling Clause 8.2.2; the complaint record must show any correction or corrective action § 820.35(a)(6) |
| 02Investigate and find the root cause | Narrative, root cause, scope to other lots or productsMeaning: Authorship of the investigation | Every edit to the root cause is trailed, and “Record changes shall not obscure previously recorded information” § 11.10(e) | Investigating the cause, now under Clause 8.5.2 (the former § 820.100(a)(2)) |
| 03Approve the action plan | Actions, owners, due datesMeaning: Approval | Printed name, date and time, meaning § 11.50(a); two components to sign § 11.200(a); only named approvers § 11.10(g) | “Approved” in ISO 13485 means a signature and date (QMSR preamble) |
| 04Implement | Evidence each action is done; linked change controlsMeaning: Completion | The system enforces the order of steps § 11.10(f), so tasks cannot close before they exist or before approval | Changes to methods and procedures recorded (the former § 820.100(a)(5), now Clause 8.5.2) |
| 05Check effectiveness | Criteria set in advance, data, resultMeaning: Verification | A separate signature with its own meaning § 11.50(a), linked to this CAPA so it cannot be copied to another § 11.70 | Verify or validate that the action is effective (the former § 820.100(a)(4), now Clause 8.5.2) |
| 06Close | Closure summary, final statusMeaning: Approval of closure | Name, date and time and meaning on every screen and printout § 11.50(b); accurate, complete copies § 11.10(b) | CAPA results go to management review: FDA says ISO 13485 covers the substance of the former § 820.100(a)(7) |
| 07Keep | The CAPA, its trail and its signaturesMeaning: No new signature | Ready retrieval for the retention period § 11.10(c); trail kept as long as the record § 11.10(e) | Record control Clause 4.2.5 plus § 820.35 |
Inspection risk
Closing a CAPA on the strength of the action alone. The closure signature then records that work was done, not that it worked, and the effectiveness check the rules expect is missing from the record.
Requirement by requirement
The rows run in the order a CAPA meets them: the signature, then the trail, then copies and validation. The open-system row (§ 11.30) is left out: no vendor here describes open-system controls, and three call their systems closed.
Scroll sideways for all vendors
| Requirement | TrackWise Digital | MasterControl Quality Excellence | Veeva QMS | Reliance | Qualio | Scilife | Ideagen Quality Management |
|---|---|---|---|---|---|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | verified | verified | verified | stated | stated | stated | stated |
| Two distinct components to sign§ 11.200(a) | verified | verified | verified | stated | verified | stated | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | verified | stated | verified | stated | stated | stated | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified | verified | verified | stated | verified | verified | stated |
| Audit trail kept as long as the record§ 11.10(e) | verified | stated | verified | stated | verified | stated | stated |
| Access and authority checks by role§ 11.10(d), (g) | verified | verified | verified | stated | verified | stated | stated |
| Accurate, complete copies for inspection§ 11.10(b) | verified | verified | verified | stated | verified | stated | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified | verified | verified | verified | verified | verified | stated |
| EU Annex 11 statementEU GMP Annex 11 | verified | not stated | stated | stated | stated | stated | not stated |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
TrackWise Digital's statuses come from the vendor's Part 11 and Annex 11 assessment. We read it on 2026-10-22; the document itself is dated March 2019, so ask for the assessment that matches the release you would buy.
How much each vendor documents
| Vendor | verified | stated | not stated |
|---|---|---|---|
| TrackWise Digital | 9 of 9 | 0 of 9 | 0 of 9 |
| MasterControl Quality Excellence | 6 of 9 | 2 of 9 | 1 of 9 |
| Veeva QMS | 8 of 9 | 1 of 9 | 0 of 9 |
| Reliance | 1 of 9 | 8 of 9 | 0 of 9 |
| Qualio | 6 of 9 | 3 of 9 | 0 of 9 |
| Scilife | 2 of 9 | 7 of 9 | 0 of 9 |
| Ideagen Quality Management | 0 of 9 | 8 of 9 | 1 of 9 |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
TrackWise Digital documents 9 of 9 rows and is built around quality events and CAPA, so it takes best overall. Veeva QMS documents 8 from the Vault platform's current help pages, and runs complaints next to CAPAs, which is the pairing a device maker's complaint record needs; the medical device QMS comparison reads the device-specific suites. Qualio, with 6, documents the things a small team cannot build itself: the signing components, a trail kept for the life of the system, and a validation pack.
Of the rest, MasterControl documents the signature itself best: the meaning on every signed record and a separate approval password are both verified, while how long the trail is kept is claimed but not described. Reliance and Scilife verify their validation packages but only state their signature rows; Ideagen states its signature rows and verifies none of the rows on the pages we read.
The CAPA rows to test in a demo
The rows that make CAPA software different from a document system are not in our register: we read no vendor's pages on them, so we give no status. Run them as a script in each demo, write the ones you need into your user requirement specification, and test them again in validation.
Scroll sideways for all columns
| CAPA control | Ask the vendor to show | It fails if | Rule |
|---|---|---|---|
| Signed effectiveness check | A closed CAPA whose effectiveness check carries its own signature, by someone other than the action owner, with its own meaning. | The check is a checkbox or a free-text field, or the closure signature stands in for it. | § 11.50(a); ICH Q10; Clause 8.5.2 |
| Closure waits for the check | Try to close a CAPA while its effectiveness check is still open. | The system lets it close and expects someone to reopen it later. | § 11.10(f) |
| Linked deviations, complaints and findings | Open a CAPA from a deviation, then open the deviation: the link shows from both sides and survives closure. | The link is a record number typed into a text field. | § 211.192; § 820.35(a)(6) |
| Audit trail on root-cause edits | Change the root cause after the plan is approved, then open the trail for that field. | The trail says only “record updated”, or the first root cause can no longer be read. | § 11.10(e); reason for change Annex 11 § 9 |
| Approval after an edit | Edit an approved action plan and look at the approval block. | The old approval still shows against content its signer never saw. | § 11.70; § 11.10(e) |
| Due-date extensions | Extend a due date: who asked, who approved, old and new date. | The date is overwritten with nothing in the trail. | § 11.10(e); § 11.10(g) |
| Who can sign what | Sign in as a user with edit rights but no QA role and try to approve closure. | Anyone who can edit the CAPA can also sign its approval. | § 11.10(g) |
| The printed CAPA | Print or export a closed CAPA with its trail. | The PDF drops the signature meaning, or the trail cannot be exported in readable form. | § 11.50(b); § 11.10(b) |
Two of these cross into neighbouring systems. Actions that change a procedure or a process belong in change control, and audit findings that open a CAPA come from the audit management side; check that the link holds in both directions.
Vendor by vendor
Each card shows the six rows a CAPA approval leans on. Some quality vendors' pages could not be read on the read date, so they are not in this lineup; a missing vendor is not a verdict on it.
TrackWise Digital
eQMS- What it is
- A cloud quality management system covering quality events, deviations, CAPA, audits, change control, documents, training, complaints and supplier quality. Sparta Systems is part of Honeywell.
- Who it fits
- Pharma, biotech and device companies that want quality events, CAPA and change control in one system.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | verifiedRead in the vendor's Part 11 and Annex 11 assessment, dated March 2019. |
| Two distinct components to sign§ 11.200(a) | verifiedUser ID and password; the password is needed at each signing. |
| Signature linked to its record so it cannot be moved§ 11.70 | verified |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verifiedRecords user ID, old and new value, and time stamp; entries cannot be deleted. |
| Audit trail kept as long as the record§ 11.10(e) | verified |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedA validation package is available for each release. |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Sparta Systems' own Part 11 pageread 2026-10-22
MasterControl Quality Excellence
eQMSdocument control- What it is
- A quality management suite covering document control, change control, training, audits, risk and quality events. MasterControl also offers validation tools with pre-written test protocols.
- Who it fits
- Life sciences manufacturers and labs, from startups to large companies, that want one suite for every quality process.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | verifiedSigned records capture the username, date and time, and meaning of the signature. |
| Two distinct components to sign§ 11.200(a) | verifiedA separate approval password is needed to sign, apart from the login password. |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedIQ, OQ and PQ test protocols offered to customers, updated with each build. |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on MasterControl's own pages. Ask MasterControl for its validation documentation and test the control in your own validation before you rely on it.
MasterControl's own Part 11 pageread 2026-10-22
Veeva QMS
eQMS- What it is
- A cloud quality management application on the Veeva Vault platform. It runs deviations, CAPAs, change controls, internal and external audits, complaints, lab investigations and supplier quality.
- Who it fits
- Pharma, biotech and device companies that bring sites, suppliers and contract manufacturers into one system.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | verifiedEach eSignature holds the signer's name, title, signing date and time, and the meaning chosen. |
| Two distinct components to sign§ 11.200(a) | verifiedSigners enter username and password; saved browser passwords are blocked. |
| Signature linked to its record so it cannot be moved§ 11.70 | verifiedEach eSignature is a read-only child record that points to the record that was signed. |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | verifiedDocument and object audit history have no retention limit. |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedA validation package binder for each release, in a vault customers can log in to. |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Veeva Systems' own Part 11 pageread 2026-10-22
Reliance
eQMS- What it is
- A configurable cloud quality management platform, formerly ETQ Reliance, with applications for document control, CAPA, change, audits, nonconformance and supply chain quality. Its Life Sciences Compliance application adds Part 11 controls and validation support.
- Who it fits
- Larger manufacturers and life sciences companies with many quality processes to configure.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedA Validation Execution Package for self-validation, or validation consulting. |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Octave's own pages. Ask Octave for its validation documentation and test the control in your own validation before you rely on it.
Octave's own Part 11 pageread 2026-10-22
Qualio
eQMSdocument control- What it is
- A cloud quality management system for life sciences covering documents, training, CAPA, change control, events, audits, suppliers and design controls. Customers receive a validation pack with test scripts and a Part 11 assessment.
- Who it fits
- Drug, biotech, device and CRO teams building or replacing their eQMS.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | verifiedEmail (user ID) plus a Qualio password form the signature, also for SSO users. |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | verifiedAudit trail records are kept for the lifetime of the customer's system. |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Qualio's own pages. Ask Qualio for its validation documentation and test the control in your own validation before you rely on it.
Qualio's own Part 11 pageread 2026-10-22
Scilife
eQMSdocument control- What it is
- A pre-validated eQMS covering documents, training, CAPA, change control, deviations, audits and supplier qualification. Customers get an executed validation package from the start.
- Who it fits
- GMP pharma and biotech companies that want validation documents delivered with the system.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verifiedEvery record is attributed to a named user with a timestamp. |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedPlan, URS, risk assessment, IQ, OQ, PQ, trace matrix and summary reports. |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Scilife's own pages. Ask Scilife for its validation documentation and test the control in your own validation before you rely on it.
Scilife's own Part 11 pageread 2026-10-22
Ideagen Quality Management
eQMSdocument control- What it is
- A connected quality management system with modules for document control, audits, CAPA, training, risk, suppliers and reporting. Audits can run offline with checklists.
- Who it fits
- Regulated companies that want audits, CAPA, documents and suppliers in one system.
| Requirement | Status |
|---|---|
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | stated |
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | stated |
verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.
Check with the vendor
Some rows above are stated or not stated on Ideagen's own pages. Ask Ideagen for its validation documentation and test the control in your own validation before you rely on it.
Ideagen's own Part 11 pageread 2026-10-22
How we read the vendors
Verdicts are editorial: no vendor can buy a verdict position or displace another vendor.
verified means we read the control described on the vendor's own documentation (help centre, validation pack page, compliance paper or trust page) on 2026-10-22. stated means the vendor claims it and we did not check it. not stated means the vendor publishes nothing on it.
FDA keeps no list of certified or approved Part 11 software. Compliance is a validation claim each regulated company makes for its own use of a system, so a vendor's Part 11 claim is where your validation starts, not where it ends.
Questions
Is there FDA-approved or certified CAPA software?
No. FDA keeps no list of certified or approved Part 11 software. Part 11 binds the people who use a system, so a “Part 11 compliant” CAPA module means the vendor states its product supports the controls. You still validate it for your own use § 11.10(a) and write the policy that holds signers accountable § 11.10(j).
Do CAPA approvals have to be electronic signatures?
No. The rules ask for approval, not for a medium. In the QMSR preamble FDA reads “approved” in ISO 13485 as a signature and date, and accepts signatures that meet its electronic signature requirements. Once the approval is electronic, those requirements are Part 11's: the manifestation § 11.50, the link to the record § 11.70 and the signing components § 11.200. The signature manifestation check tests one signed record against § 11.50.
What is the difference between a correction, a corrective action and a preventive action?
The QMSR takes all three definitions from ISO 9000. FDA's preamble puts the line plainly: a correction eliminates a nonconformity (scrap, repair, rework or adjustment), while a corrective action eliminates its cause and prevents recurrence. Preventive action is aimed at potential nonconformities and has its own clause in ISO 13485 Clause 8.5.3. A CAPA record that logs only the correction has not done the second half.
Does Part 11 require a reason for every change to a CAPA?
Not in those words. § 11.10(e) asks for a secure, time-stamped trail of entries and actions, and says changes “shall not obscure previously recorded information”. A documented reason for changing GMP-relevant data comes from EU GMP Annex 11 § 9, which also expects trails to be regularly reviewed. If you sell into the EU, make the reason field mandatory on root cause and due dates. Our guide to GxP audit trails covers what an entry should hold.
Does FDA's CSA guidance cover a CAPA system?
For device makers, yes: it covers “computers or automated data processing systems used as part of production or the quality management system”, and a CAPA system is quality management software. FDA asks you to focus assurance on record integrity and the Part 11 requirements that apply, so CSA does not remove Part 11. For a drug maker, FDA wrote CSA for device makers; its risk ideas are often borrowed elsewhere. The CSA vs CSV guide sets the two side by side.
Can a small team run CAPA on paper or a spreadsheet first?
Yes. FDA's 2003 guidance says that when paper printouts meet the predicate rule and are what you rely on, using a computer to produce them does not trigger Part 11. A spreadsheet that is itself the CAPA record does, and then it needs the same trail and signature controls; see Excel spreadsheets under Part 11. The CAPA form template prints a paper form with a signed effectiveness check and closure.
How long do we keep CAPA records and their audit trail?
Part 11 sets no period of its own: the trail is kept as long as the record § 11.10(e), and the record's period comes from the predicate rule. For drug CGMP records it is at least one year after the batch expires § 211.180; drug complaint records are kept at least one year after the product expires or one year after the complaint arrived, whichever is longer § 211.198(b). Device makers work to ISO 13485 record control Clause 4.2.5, which § 820.35 builds on; the standard is sold by ISO, so we do not restate its period here.
Sources
- 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
- Part 11, Electronic Records; Electronic Signatures: Scope and Application (guidance, 2003), FDAread 2026-10-22
- Medical Devices; Quality System Regulation Amendments, final rule, 89 FR 7496 (2024), Federal Registerread 2026-10-22
- 21 CFR Part 820, Quality Management System Regulation, eCFRread 2026-10-22
- 21 CFR 820.100, Corrective and preventive action (text in force before February 2, 2026), eCFRread 2026-10-22
- 21 CFR Part 211, CGMP for Finished Pharmaceuticals (§§ 211.22, 211.100, 211.180, 211.192, 211.198), eCFRread 2026-10-22
- Q10 Pharmaceutical Quality System (guidance, April 2009), FDAread 2026-10-22
- Data Integrity and Compliance With Drug CGMP: Questions and Answers (2018), FDAread 2026-10-22
- Computer Software Assurance for Production and Quality Management System Software (guidance, 2026), FDAread 2026-10-22
- EudraLex Volume 4, Annex 11: Computerised Systems (2011), European Commissionread 2026-10-22