Calibration management software: five systems read against Part 11
Published , reviewed
Verdict
- Best overall
- GAGEtrak with FDA Compliance ManagerIts FDA Compliance Manager permanently turns on security, the audit trail and electronic signatures, the trail is preserved indefinitely, and it ships a validation guide and checklist: four of the 10 rows on this page are described on CyberMetrics' own pages.
- Best with field calibrators
- Beamex CMXIt takes results from Beamex documenting calibrators and the bMobile app, user-group permissions limit who performs each operation, and Beamex offers to write the validation plan and run IQ, OQ and PQ with you.
- Best inside a quality suite
- Qualityze Calibration ManagementCalibration connects to Qualityze's CAPA, change management and document control modules on one Salesforce-based platform; its Part 11 support is stated, not described, on the pages we read.
Fig. 01Calibration management software keeps the instrument register, the schedule, every calibration result and the action taken when an instrument fails. In a GMP, GLP or device setting that record is required by a predicate rule, so once software holds it in place of paper it is a Part 11 record: its edits need a trail, and the technician's and reviewer's sign-offs are electronic signatures.
This page follows one failed calibration through the system, sets out what the rules ask the record to hold, works out what a failure puts in question, and reads five calibration management systems against the 10 rows of our Part 11 register. Monitoring probes have their own page: the temperature monitoring comparison covers calibration records for logger probes.
One failed calibration, field by field
A calibration that passes tells you little about a system. A failed one shows whether it keeps the first reading, takes the instrument out of use and asks what the instrument measured while it was out. Here is one, as the record should hold it.
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| Field | In the record | What the system has to do |
|---|---|---|
| Instrument | PG-114, pressure gauge, filling line 2 | One identity tied to its location and its calibration procedure. Only named roles add or edit instruments § 11.10(g). |
| Interval and due date | 180 days, due 2026-10-22 | An interval is part of the written program. For a drug maker, changes to records go in “only by authorized personnel” § 211.68(b), and every change lands in the trail § 11.10(e); route it through change control. |
| Reference standard | DPC-07, own calibration due 2027-03-01 | Records which standard was used and its own status. If your SOP bars a standard past its date, the system can enforce that order of steps § 11.10(f). |
| As-found reading | Test point 6.00 bar, read 6.21 bar, limit ±0.10 bar: OUT | Kept exactly as first recorded, with the technician and the time. “Record changes shall not obscure previously recorded information” § 11.10(e); our guide to GxP audit trails covers what each entry holds. |
| Status | Out of service, 2026-10-21 09:42 UTC | An instrument that misses its limits “shall not be used” § 211.160(b)(4). The status change is trailed like any other entry. |
| Impact on product | DEV-0291 opened: lots measured since 2026-04-25, the last pass | The remedial action your program provides for. The former device rule asked whether there was “any adverse effect on the device's quality” § 820.72(b). Link the two records both ways, and to the CAPA if the cause needs fixing. |
| Adjustment and as-left reading | Adjusted; read 6.02 bar: IN | A second reading beside the as-found one, never in its place. |
| Performed by | e-signed by the technician, 2026-10-21 10:15 UTC, meaning: performed | Printed name, date and time, and meaning, on screen and on every printout § 11.50; two components to sign § 11.200(a). FDA does not expect the signer's local time, but your documents should say which time zone the system uses. |
| Reviewed by | e-signed by QA, 2026-10-21 14:03 UTC, meaning: reviewed | A second signature with its own meaning, linked to this record so it cannot be copied to another § 11.70. |
| Next due date | Interval cut to 90 days, due 2027-01-19 | A shortened interval after a failure is a change to the program: same authority checks and trail as the interval row above. |
Inspection risk
An as-found reading replaced by the as-left one. The record then shows an instrument that was always in tolerance, and nothing prompts the question of what it measured while it was out. If anything measured with it reached product, that question belongs in your deviation process.
What a calibration management system must hold
Three rule sets reach a calibration record, and the one that named its fields most plainly is no longer in the CFR: the device rule § 820.72 was removed on February 2, 2026. The table keeps it as a field list, beside the drug CGMP and GLP sections still in force.
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| The record holds | Drug CGMP (21 CFR 211) | GLP (21 CFR 58) | Devices, former § 820.72 (until 2026-02-02) |
|---|---|---|---|
| A written program with directions and schedules | “an established written program containing specific directions, schedules” § 211.160(b)(4); equipment checked “according to a written program” § 211.68(a) | SOPs setting “the methods, materials, and schedules” § 58.63(b) | Procedures so that equipment “is routinely calibrated, inspected, checked, and maintained” § 820.72(a) |
| Limits for accuracy and precision | “limits for accuracy and precision” § 211.160(b)(4) | Not named in the section; set it in your SOP | “specific directions and limits for accuracy and precision” § 820.72(b) |
| A record of each calibration and its date | “Complete records” of the periodic calibration § 211.194(d) | Written records of each operation, “containing the date of the operation” § 58.63(c) | “calibration dates” § 820.72(b)(2) |
| Who performed it | Not named in the section; set it in your SOP | SOPs “shall designate the person responsible” for each operation § 58.63(b) | “the individual performing each calibration” § 820.72(b)(2) |
| The next due date | Not named in the section; set it in your SOP | Not named in the section; set it in your SOP | “the next calibration date” § 820.72(b)(2) |
| What happens when a calibration fails | “provisions for remedial action”; equipment not meeting specifications “shall not be used” § 211.160(b)(4) | Remedial action “in the event of failure or malfunction” § 58.63(b); repair records give “the nature of the defect, how and when the defect was discovered” § 58.63(c) | Remedial action, and “evaluate whether there was any adverse effect on the device's quality” § 820.72(b) |
| Reference standards | Records of “testing and standardization of laboratory reference standards” § 211.194(c) | Not named in the section; set it in your SOP | Standards “traceable to national or international standards” where practical § 820.72(b)(1) |
What replaced § 820.72
Since February 2, 2026 a device maker's calibration duty sits in ISO 13485, which Part 820 incorporates by reference § 820.7. FDA's inspection program for device makers lists “Control of Monitoring and Measuring Equipment” against Clause 7.6. ISO sells the standard, so we do not restate it; the old field list is a fair checklist to read against your copy.
EU GMP asks the same in one sentence: equipment “should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained” EU GMP Ch. 3.41. None of these rules names software. They name a program, limits, records and an answer to a failure, and a calibration management system earns its place by holding all four in one record.
What a failed calibration puts in question
A failed as-found check does not date the drift. All you know is that the instrument passed on one day and failed on another, so everything it measured in between is in question until your assessment says otherwise. Enter the two dates and what the instrument was used for.
Window: 2026-04-25 to 2026-10-21, 179 days
Used for: Testing drug product for release
- 01Take the instrument out of use now: equipment that misses its limits “shall not be used” (§ 211.160(b)(4)).
- 02Keep the as-found reading and add the as-left one beside it: record changes “shall not obscure previously recorded information” (§ 11.10(e)).
- 03Pull every record made with this instrument from 2026-04-25 to 2026-10-21. A system that stores the instrument ID on each result gives you that list in one search.
- 04Every result in the window is suspect until shown otherwise. Your SOP decides whether that is a deviation; for a batch already released, § 211.192 asks that a discrepancy be “thoroughly investigated, whether or not the batch has already been distributed”.
- 05Review the interval: this instrument went out of limits somewhere inside 179 days. A shorter interval is a change to the program, made by an authorized role and trailed.
Step 03 is where calibration software earns its keep or does not: if results carry the instrument ID, the list is one search; if they do not, it is a week in the archive. Ask each vendor how a result in your LIMS or batch record points back to the instrument and its calibration status.
Calibration checks to run in a demo
Every vendor will demo a calibration that passes. Ask for the failure paths instead, on the vendor's system with your own instrument types. We read no vendor's pages on these checks, so the register gives them no status.
- 01
An overdue instrument is stopped
Do: Let an instrument pass its due date, then try to record a reading with it or schedule its use.
Passes if: The system blocks or flags it, and the attempt shows in the trail.
Equipment not meeting specifications “shall not be used” § 211.160(b)(4)
- 02
As-found survives the adjustment
Do: Enter an out-of-limit as-found result, adjust, then enter the as-left result.
Passes if: Both readings stay visible on the record and on the certificate, and the status went to out of service in between.
Changes “shall not obscure previously recorded information” § 11.10(e)
- 03
A failure opens the impact question
Do: Close a failed calibration without answering what the instrument measured since its last pass.
Passes if: The system will not close it, or it links the record to a deviation or impact assessment you can open from either side.
The system enforces the order of steps you set § 11.10(f)
- 04
The reference standard is checked too
Do: Calibrate with a reference standard whose own calibration has lapsed.
Passes if: The system refuses or flags it, and every record names the standard that was used.
Your SOP sets the rule; the system enforces it § 11.10(f)
- 05
Limits and intervals are controlled
Do: Change a tolerance limit or an interval as an ordinary user, then as an administrator.
Passes if: Only a named role can, the change is approved, and the trail shows old value, new value and who. A reason field covers EU sites.
§ 11.10(g); reason for change Annex 11 § 9
- 06
Calibrator data arrives untouched
Do: Import a result from a documenting calibrator or a mobile app.
Passes if: No retyping, and the record names the device the data came from.
Device checks on the source of data input § 11.10(h)
- 07
One record, exported whole
Do: Export a signed calibration record with its trail.
Passes if: A readable copy and an electronic copy, each showing every signer's name, date and time and meaning.
§ 11.10(b); § 11.50(b)
Write the checks you need into your user requirement specification, then run them again in your own validation; the IQ OQ PQ template lays out the protocol.
Requirement by requirement
The rows run in the order a calibration record meets them: the trail and who may touch the record, then the two signatures, then copies, validation support and the EU statement.
Scroll sideways for all vendors
| Requirement | GAGEtrak with FDA Compliance Manager | Beamex CMX | ProCal | Qualityze Calibration Management | IndySoft |
|---|---|---|---|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified | stated | verified | stated | stated |
| Audit trail kept as long as the record§ 11.10(e) | verified | stated | stated | stated | stated |
| Access and authority checks by role§ 11.10(d), (g) | verified | verified | stated | stated | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated | stated | stated | stated | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | stated | stated | stated | stated | stated |
| Two distinct components to sign§ 11.200(a) | stated | stated | stated | stated | stated |
| Accurate, complete copies for inspection§ 11.10(b) | stated | stated | stated | stated | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified | verified | stated | not stated | not stated |
| Open-system controls: encryption, digital signatures§ 11.30 | stated | not stated | not stated | not stated | not stated |
| EU Annex 11 statementEU GMP Annex 11 | not stated | not stated | not stated | not stated | not stated |
verified: read on the vendor's own documentation on 2026-10-24. stated: the vendor claims it; we did not check. not stated: nothing published.
How much each vendor documents
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| Vendor | verified | stated | not stated | Described on its own pages |
|---|---|---|---|---|
| GAGEtrak with FDA Compliance Manager | 4 of 10 | 5 of 10 | 1 of 10 | audit trail, trail retention, validation support, access by role |
| Beamex CMX | 2 of 10 | 6 of 10 | 2 of 10 | validation support, access by role |
| ProCal | 1 of 10 | 7 of 10 | 2 of 10 | audit trail |
| Qualityze Calibration Management | 0 of 10 | 7 of 10 | 3 of 10 | none |
| IndySoft | 0 of 10 | 7 of 10 | 3 of 10 | none |
verified: read on the vendor's own documentation on 2026-10-24. stated: the vendor claims it; we did not check. not stated: nothing published.
GAGEtrak with FDA Compliance Manager documents 4 of 10 rows (audit trail, trail retention, validation support and access by role), the most here, and takes best overall: its Part 11 mode is a companion product that turns security, the trail and signatures on permanently. Beamex CMX documents 2 (validation support and access by role) and fits where technicians already carry Beamex documenting calibrators.
Of the rest, ProCal describes its audit trail (every action logged with a timestamp) and states seven of the other rows; IndySoft claims Part 11 support in general words and describes none of the rows on the pages we read. A stated row is a question for the demo, not a gap: ask to see it.
Vendor by vendor
Each card shows the six rows a calibration record leans on most. Some vendors we tried to read are not here: their sites refused our requests on the read date, or their calibration pages make no Part 11 statement. A missing vendor is not a verdict on it.
GAGEtrak with FDA Compliance Manager
calibration- What it is
- Calibration management software from CyberMetrics. Its companion FDA Compliance Manager switches a GAGEtrak database to FDA mode, which permanently turns on security, audit trails, login timeout and electronic signatures.
- Who it fits
- Device makers and labs that run gage calibration in house and want the Part 11 controls locked on.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | verifiedThe Part 11 version enables the audit trail and preserves it indefinitely. |
| Access and authority checks by role§ 11.10(d), (g) | verified |
| Signature shows name, date and time, and meaning§ 11.50 | statedSignature history keeps the date, time and signer; the page does not name the meaning. |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedA validation guide and checklist for your own validation, plus on-site validation services. |
verified: read on the vendor's own documentation on 2026-10-24. 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 CyberMetrics' own pages. Ask CyberMetrics for its validation documentation and test the control in your own validation before you rely on it.
CyberMetrics' own Part 11 pageread 2026-10-24
Beamex CMX
calibration- What it is
- Calibration management software that holds the instrument and reference-equipment register, plans calibrations and stores every result. It takes results from Beamex documenting calibrators and the bMobile app, and installs on premises or in a cloud service such as Microsoft Azure.
- Who it fits
- Process plants and pharma sites that calibrate field instruments with documenting calibrators.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | verifiedUser-group permissions limit who can access the system and perform each operation. |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verifiedBeamex offers to write the validation plan and run IQ, OQ and PQ with the customer. |
verified: read on the vendor's own documentation on 2026-10-24. 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 Beamex's own pages. Ask Beamex for its validation documentation and test the control in your own validation before you rely on it.
Beamex's own Part 11 pageread 2026-10-24
ProCal
calibration- What it is
- Calibration management software that plans intervals by date or usage, runs guided test routines with automated calculations and pass or fail against tolerances, and keeps records and certificates. It connects to ERP and EAM systems such as SAP and Maximo, CMMS and LIMS.
- Who it fits
- Manufacturers that want calibration tied into their ERP, EAM or maintenance system.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verifiedEvery action is logged with timestamps. |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | statedValidation and compliance testing is listed as a service; no package is described. |
verified: read on the vendor's own documentation on 2026-10-24. 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 TMA Systems' own pages. Ask TMA Systems for its validation documentation and test the control in your own validation before you rely on it.
TMA Systems' own Part 11 pageread 2026-10-24
Qualityze Calibration Management
calibrationeQMS- What it is
- A calibration module of the Qualityze quality suite, built on Salesforce: calibration schedules, certificates and history on one platform. Qualityze connects it to its CAPA, change management, document control and maintenance modules.
- Who it fits
- Teams that want calibration in the same quality system as their CAPA and change control.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | not stated |
verified: read on the vendor's own documentation on 2026-10-24. 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 Qualityze's own pages. Ask Qualityze for its validation documentation and test the control in your own validation before you rely on it.
Qualityze's own Part 11 pageread 2026-10-24
IndySoft
calibration- What it is
- Calibration, maintenance and asset tracking software with configurable workflows, automated recall notices and alerts when equipment fails calibration. It runs on premises or as the hosted IndySoft Cloud.
- Who it fits
- Teams that want to set their own calibration workflow and sign-off rules.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | stated |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | stated |
| Signature shows name, date and time, and meaning§ 11.50 | stated |
| Two distinct components to sign§ 11.200(a) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | not stated |
verified: read on the vendor's own documentation on 2026-10-24. 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 IndySoft's own pages. Ask IndySoft for its validation documentation and test the control in your own validation before you rely on it.
IndySoft's own Part 11 pageread 2026-10-24
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 2026-10-24. 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 calibration management software?
No. FDA keeps no list of certified or approved Part 11 software. Part 11 binds the people who use a system, so “Part 11 compliant” on calibration software 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). A vendor's own audit or certificate does not change that.
When is a calibration record a Part 11 record?
When a predicate rule requires the record and you keep it electronically in place of paper, or rely on the electronic copy. Drug makers keep calibration records under § 211.194(d), GLP labs under § 58.63(c). FDA's 2003 guidance says that paper printouts you rely on, made with a computer, do not trigger Part 11; it recommends you document that decision in an SOP. For device makers, the CSA guidance says that if a manufacturer keeps a document required under Part 820 in electronic form, “then Part 11 generally applies.” The Part 11 applicability checker walks through it for one record.
Can we run calibration on a spreadsheet?
Yes, if the spreadsheet only schedules work and the signed record lives on paper. Once the spreadsheet is the record, it needs the same controls as any system: a time-stamped trail that keeps the old value, access by role and, if people sign in it, signatures that meet § 11.50 and § 11.70. That is hard to do in a shared workbook; see Excel spreadsheets under Part 11.
What did the QMSR change for a device maker's calibration program?
The old calibration section, § 820.72, is gone since February 2, 2026. Part 820 now incorporates ISO 13485:2016 by reference § 820.7, and FDA's device inspection program lists “Control of Monitoring and Measuring Equipment” as an element checked against Clause 7.6. ISO sells the standard, so we do not restate the clause; read your copy against the field list above. FDA does not require ISO 13485 certification. Our QMSR guide for small device makers covers the switch.
Do calibration standards have to be traceable to NIST?
The drug CGMP and GLP sections do not name NIST or any standards body: § 211.194(c) asks for records of the “testing and standardization of laboratory reference standards”. The former device rule did ask for standards “traceable to national or international standards” where practical § 820.72(b)(1). Whatever you require, put it in your calibration SOP and make the system record which standard each calibration used.
How long do we keep calibration records and their audit trail?
Part 11 sets no period of its own: the trail is kept at least as long as the record § 11.10(e), and the record's period comes from the predicate rule. GLP calibration records follow the study-record periods § 58.195(f), the shortest of those in § 58.195(b). For drug makers, the 1-year-after-expiry rule in § 211.180(a) covers records “specifically associated with a batch”; a calibration record belongs to an instrument, so set its period in your SOP and make it cover the batches the instrument measured.
Does the calibration system itself need validation?
Yes, for its intended use § 11.10(a), and the effort can follow the risk. A system that only reminds people of due dates carries less risk than one that decides pass or fail and blocks overdue instruments. Vendor test scripts or an IQ and OQ pack are a starting point, never the whole job; the CSV guide for small labs sizes the work.
Sources
- 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
- 21 CFR Part 211, CGMP for Finished Pharmaceuticals (§§ 211.68, 211.160, 211.180, 211.194), eCFRread 2026-10-24
- 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (§§ 58.63, 58.195), eCFRread 2026-10-24
- 21 CFR 820.72, Inspection, measuring, and test equipment (text in force before February 2, 2026), eCFRread 2026-10-24
- 21 CFR Part 820, Quality Management System Regulation, eCFRread 2026-10-22
- Medical Devices; Quality System Regulation Amendments, final rule, 89 FR 7496 (2024), Federal Registerread 2026-10-22
- Compliance Program 7382.850, Inspection of Medical Device Manufacturers (Attachment A), FDAread 2026-10-24
- Part 11, Electronic Records; Electronic Signatures: Scope and Application (guidance, 2003), FDAread 2026-10-22
- Computer Software Assurance for Production and Quality Management System Software (guidance, 2026), FDAread 2026-10-22
- EudraLex Volume 4, Chapter 3: Premises and Equipment, European Commissionread 2026-10-22
- EudraLex Volume 4, Annex 11: Computerised Systems (2011), European Commissionread 2026-10-22