Part 11 compliant temperature monitoring: five systems read against the storage record
Published , reviewed
Verdict
- Best overall
- Centron PresidioIt logs readings and events and reports how alarms were handled, and its own pages describe the audit trail, validation documents and two-component signing (3 of 10 rows verified): the closest fit here for a site that signs excursion reviews in the monitoring system.
- Best for a small lab
- elproCLOUDCloud monitoring for sites that want it without on-site servers, so a small lab has no server to run. Its own help pages describe role-based access (1 of 10 verified); its signature and audit-trail rows are claims to test in your own validation.
- Best for GMP storage and cleanrooms
- Vaisala viewLincMade for labs, warehouses and GMP facilities monitoring storage and cleanroom conditions, with the audit trail, role-based access and validation documents described on its own pages (3 of 10 verified). Vaisala notes that monitoring systems do not typically use electronic signatures for data review.
Fig. 01In a drug warehouse, a stability chamber or a GLP study room, the storage record is no longer a paper chart on the fridge door. It is a monitoring system that logs readings, raises alarms and keeps who did what about them. When a predicate rule requires that record and you keep it in the system, Part 11 applies to it § 11.1(b).
We read what five monitoring vendors publish about each Part 11 control on their own pages and set it against the record one storage excursion leaves behind. Each system is sold with sensors and loggers; this page reads the record-keeping software only. For lab data beyond storage conditions, see data integrity software for GxP labs.
Which rules make a temperature record
Part 11 adds no monitoring duty of its own. The duty to control and show storage conditions comes from the predicate rules; these nine are the ones a monitoring system usually serves.
Scroll sideways for all columns
| Where the reading matters | Rule | What it asks | The record you keep |
|---|---|---|---|
| Drug warehouse, cold room, fridge | § 211.142(b) | Written warehousing procedures that include storage “under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected” | The storage-condition data your warehousing SOP says you keep |
| Equipment that controls temperature | § 211.46(b) | Equipment for “adequate control over air pressure, micro-organisms, dust, humidity, and temperature” when appropriate for holding a drug product | Readings that show the equipment held its range |
| Aseptic processing areas | § 211.42(c)(10)(ii), (iv) | “Temperature and humidity controls” and “A system for monitoring environmental conditions” | The monitoring system's data for each aseptic room |
| Stability chambers | § 211.166(a)(2), § 211.194(e) | A written stability program that includes “Storage conditions for samples retained for testing”; “Complete records shall be maintained of all stability testing” | Chamber conditions as part of the stability record |
| The monitoring system itself | § 211.68(a) | Electronic equipment is “routinely calibrated, inspected, or checked according to a written program”, and “Written records of those calibration checks and inspections shall be maintained” | Calibration and check records for probes and loggers |
| GLP study rooms and equipment | § 58.61, § 58.3(k) | Equipment “used for facility environmental control” of appropriate design; raw data “may include … recorded data from automated instruments” | Readings that form part of a study's raw data |
| GLP test and control articles | § 58.105(c), § 58.107(a) | Containers labelled with the “storage conditions necessary to maintain the identity, strength, purity, and composition”; handling procedures that ensure “There is proper storage” | Storage data for each test article's location |
| GLP archives | § 58.190(b) | “Conditions of storage shall minimize deterioration of the documents or specimens” | Archive room conditions over the retention period |
| EU GMP storage areas | EU GMP Ch. 3.19 | “Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.” | Monitoring data for every area with special conditions |
Common misreading
“The CFR requires continuous monitoring every five minutes.” None of the US sections above sets an interval, a number of probes or an alarm delay: they ask for appropriate conditions, written procedures and records. EU GMP Chapter 3 says “checked and monitored”, also without an interval. Interval, probe placement and alarm delays come from your own risk assessment and SOP.
FDA's 2003 guidance says it does not intend to enforce the Part 11 versions of validation, audit trail, copies and retention, but it enforces every predicate rule, including § 211.68(b) (changes only by authorized personnel, an exact and complete backup), and the signature sections in full.
One excursion, record by record
A fridge runs warm overnight. These seven events each leave a record, and most of them are made by people, not the logger. That is where Part 11 bites. What a trail on those entries has to capture is covered in what an audit trail is in GxP.
- 0102:14 UTC
A reading leaves the range
Fridge 07, probe 2: 8.6 °C (limit 2.0 to 8.0 °C)
The reading is the data, not an audit-trail entry: the logger makes it, no operator does. FDA lists a date/time stamp and an instrument ID among the metadata that make a value meaningful; in a GLP study such readings can be raw data, which “may include … recorded data from automated instruments” § 58.3(k).
Check: Does each stored reading carry the probe ID and the time it was taken, and can anyone edit or delete it?
- 0202:24 UTC
The system raises an alarm
Alarm HIGH, fridge 07, delay 10 min, SMS to on-call list
FDA's 2018 Q&A names “alert records” among the audit trails that may be appropriate to review on a risk-based frequency. Whether an alarm is an incident is your SOP's call; Annex 11 asks that “All incidents, not only system failures and data errors” be “reported and assessed” Annex 11 § 13.
Check: Is the alarm, its delay and every notification sent kept as a record, not only shown on screen?
- 0302:41 UTC
Someone acknowledges the alarm
Acknowledged by on-call technician, 02:41 UTC
An operator action, so it belongs in the time-stamped trail § 11.10(e), made only by someone authorised § 11.10(d), (g). Annex 11 expects systems to record who confirms data “including date and time” Annex 11 § 12.4.
Check: Does the acknowledgement name one person, or a shared login kept at a desk?
- 0402:55 UTC
A comment explains the excursion
“Door left ajar after restock. Stock moved to fridge 03.”
An operator entry that creates a record. A later edit to it “shall not obscure previously recorded information” § 11.10(e), and Annex 11 wants the reason for a GMP-relevant change documented Annex 11 § 9.
Check: Can the comment be required before the alarm closes, and is the first wording kept after an edit?
- 0509:30 UTC
QA reviews and signs off
Reviewed by QA, meaning: Reviewed, 09:30 UTC
If your SOP makes this an electronic signature, it shows name, date and time, and meaning § 11.50, stays linked to the excursion record § 11.70 and uses two components § 11.200(a). Where the excursion is an unexplained discrepancy in a drug batch's records, § 211.192 asks for a thorough investigation and a written record.
Check: Is the sign-off a true e-signature with a meaning, or a tick box with a user name beside it?
- 06Next day
Someone widens the alarm limit
High limit changed from 8.0 to 8.5 °C, fridge 07
A change to the system's configuration: Annex 11 wants it made “only in a controlled manner in accordance with a defined procedure” Annex 11 § 10, and authority checks decide who may alter it § 11.10(g).
Check: Do limit, delay and probe-offset changes land in the same trail as the readings, with the old value shown?
- 07Month end
The report goes to QA or an inspector
PDF and export for fridge 07, readings, alarms and trail
Accurate and complete copies in human-readable and electronic form § 11.10(b), retrievable for the retention period § 11.10(c), which comes from the predicate rule, e.g. § 211.180(a) or § 58.195. The trail is kept as long as the record § 11.10(e).
Check: Does the export carry the alarms, comments and trail with the readings, or the readings alone?
Takeaway
Run this scenario in every vendor demo and ask for the report at the end. If the excursion comment, the acknowledgement and the limit change are not in it, they are not in your record either. The audit trail review checklist turns the events into a review routine once the system is live.
Time stamps, gaps and buffered readings
A monitoring record carries two kinds of time. The reading's own stamp is metadata: FDA's 2018 Q&A gives “a date/time stamp documenting when the data were acquired” as an example, alongside the instrument ID. The audit trail's stamps record “the date and time of operator entries and actions” § 11.10(e), such as the acknowledgement and the comment. A logger that uploads late should keep the first kind as the time of acquisition, not the time the server received it.
Time zones matter once you run more than one site or a cloud server abroad. FDA's 2003 guidance says “we do not expect you to record the signer's local time”, but your documentation should explain the time-zone reference. Pick one rule (local time with offset, or UTC) and state it in the SOP and on the report.
Gaps are where storage records fail. FDA's ALCOA asks for data that is “contemporaneously recorded”, and the four attributes listed in PIC/S PI 041-1 add “Complete”: nothing lost or deleted, metadata included. Drug CGMP wants backup data “exact and complete” § 211.68(b), and Annex 11 asks systems that exchange data electronically, as a logger and a server do, to include “appropriate built-in checks for the correct and secure entry and processing of data” Annex 11 § 5. To test a record against all five ALCOA attributes and the four added ones, use the ALCOA+ record check.
Most gaps come from a network or server outage while the logger keeps measuring. Whether the record has a hole then depends on the logger's memory, its logging interval and what it does when the memory fills.
Logger buffer check
Example values. Use your logger's datasheet and your longest likely outage.
Gap in the record
12 h 40 min of readings lost
1152 readings fall due during the outage; the memory holds 1000 (83 h 20 min). The last 12 h 40 min of the outage will be missing from the record, never recorded.
Solid: readings held and uploaded later. Hatched: readings missing. Assumes the memory was empty when the outage began.
Common misreading
A trend line drawn straight across a gap looks complete. Ask whether the chart, the PDF report and the export each mark missing readings as missing, and whether the system raises an alarm when a logger stops reporting, not only when a value goes out of range.
Takeaway
Put an outage in your OQ: cut one logger's connection for longer than its alarm delay, then check the trend, the report and the audit trail for the gap, the alarm and the upload. The IQ OQ PQ template has a test-step format for it.
Calibration records
A reading is only as good as the probe behind it. The rules ask for a written calibration program and records of every calibration and check; the monitoring software is where those readings are judged.
- § 211.160(b)(4)
- Calibration of “instruments, apparatus, gauges, and recording devices at suitable intervals” under a written program with “specific directions, schedules, limits for accuracy and precision, and provisions for remedial action”. Devices not meeting their specifications “shall not be used.”
- § 211.194(d)
- “Complete records shall be maintained of the periodic calibration of laboratory instruments, apparatus, gauges, and recording devices”.
- § 211.68(a)
- Electronic equipment is calibrated, inspected or checked under a written program, and “Written records of those calibration checks and inspections shall be maintained.”
- § 58.63(b), (c)
- SOPs set the methods and schedules for calibration and the remedial action on failure, and name the person responsible. Records carry “the date of the operation”; for a repair after a failure, “the nature of the defect, how and when the defect was discovered, and any remedial action taken”.
- § 58.195(f)
- Those maintenance and calibration records are kept for the same period as the study records under § 58.195(b).
- EU GMP Ch. 3.41
- “Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
What these rules do not say
None of these sections names a standards body, an accreditation or a “traceable” certificate. Whether you require certificates traceable to a national standard is a decision for your calibration SOP, and the SOP is where an inspector will look for it.
Ask each vendor whether the software holds each probe's calibration due date, flags readings from a probe past it (a device that fails its limits “shall not be used”), and puts any offset typed into the software in the audit trail. An offset changes every reading after it.
Requirement by requirement
Ten rows, each read on the vendor's own pages, with the audit-trail and copy rows first: for most monitoring records they carry more weight than the signature rows, unless your SOP signs reviews in the system. A row is verified only where the vendor's documentation describes the control.
Scroll sideways for all vendors
| Requirement | Vaisala viewLinc | Centron Presidio | elproCLOUD | Kaye LabWatch Pro | XiltriX |
|---|---|---|---|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified | verified | stated | verified | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated | stated | stated | stated | stated |
| Access and authority checks by role§ 11.10(d), (g) | verified | stated | verified | 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 | verified | verified |
| Signature shows name, date and time, and meaning§ 11.50 | not stated | stated | stated | stated | stated |
| Signature linked to its record so it cannot be moved§ 11.70 | not stated | stated | stated | stated | stated |
| Two distinct components to sign§ 11.200(a) | not stated | verified | stated | stated | stated |
| Open-system controls: encryption, digital signatures§ 11.30 | not stated | stated | not stated | stated | not stated |
| EU Annex 11 statementEU GMP Annex 11 | stated | not stated | not stated | not 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.
How much each vendor documents
The table, counted, with the rows each vendor describes rather than claims. Vaisala viewLinc and Centron Presidio document the most, 3 of ten rows each.
- Vaisala viewLinc
- 3 verified, 3 stated, 4 not stated
- Described on its own pages: the audit trail, validation documents and role-based access.
- Centron Presidio
- 3 verified, 6 stated, 1 not stated
- Described on its own pages: two-component signing, the audit trail and validation documents.
- Kaye LabWatch Pro
- 2 verified, 7 stated, 1 not stated
- Described on its own pages: the audit trail and validation documents.
- XiltriX
- 2 verified, 6 stated, 2 not stated
- Described on its own pages: the audit trail and validation documents.
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.
Why Centron Presidio over Vaisala viewLinc overall: it is the only system here whose own page describes two-component signing, while Vaisala's signature rows are not stated. For a site that signs excursion reviews in the system, that row decides it. If you sign reviews elsewhere, the two read closer, and Vaisala viewLinc's documented role-based access counts for more.
Running several sites? Nothing in our vendor records covers multi-site set-ups, so ask each vendor whether sites share one server or run one each, which time zone each site's reports use, and whether QA can review every site's alarms from one place. Hosted options also raise the open or closed question in the FAQ below.
Vendor by vendor
Software only
Each card covers the record-keeping software. Sensors, loggers and calibration services are sold alongside and were not read against these rows; their calibration is covered by your own program.
Vaisala viewLinc
monitoring- What it is
- The software part of Vaisala's continuous monitoring system, giving alarms, trend data and reports for temperature, humidity, CO2 and differential pressure. It is sold with Vaisala sensors and data loggers; this entry covers its record-keeping software only.
- Who it fits
- Labs, warehouses and GMP facilities monitoring storage and cleanroom conditions.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified |
| Two distinct components to sign§ 11.200(a) | 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.
Check with the vendor
Some rows above are stated or not stated on Vaisala's own pages. Ask Vaisala for its validation documentation and test the control in your own validation before you rely on it.
Vaisala's own Part 11 pageread 2026-10-22
Centron Presidio
monitoring- What it is
- The software of Rees Scientific's Centron Presidio environmental monitoring system, which logs readings and events and reports how alarms were handled. The system includes monitoring hardware; this entry covers its record-keeping software only.
- Who it fits
- Pharma, biotech and hospital sites that want monitoring together with vendor validation services.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | stated |
| Accurate, complete copies for inspection§ 11.10(b) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified |
| Two distinct components to sign§ 11.200(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 Rees Scientific's own pages. Ask Rees Scientific for its validation documentation and test the control in your own validation before you rely on it.
Rees Scientific's own Part 11 pageread 2026-10-22
elproCLOUD
monitoring- What it is
- Cloud monitoring software for temperature, humidity and other parameters measured by ELPRO's wireless sensors and data loggers, with alarms and reports. The hardware is sold alongside; this entry covers the elproCLOUD record-keeping software only.
- Who it fits
- Pharmacies, labs and storage sites that want cloud monitoring without on-site servers.
| 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) | verified |
| Accurate, complete copies for inspection§ 11.10(b) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | stated |
| Two distinct components to sign§ 11.200(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 ELPRO's own pages. Ask ELPRO for its validation documentation and test the control in your own validation before you rely on it.
ELPRO's own Part 11 pageread 2026-10-22
Kaye LabWatch Pro
monitoring- What it is
- Kaye's environmental monitoring and alarm software for labs, warehouses and stability chambers, keeping a secure archive of monitored values for reports. It runs with Kaye sensors; this entry covers its record-keeping software only.
- Who it fits
- Sites monitoring stability chambers and storage that also want IQ/OQ services from the vendor.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | stated |
| Accurate, complete copies for inspection§ 11.10(b) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified |
| Two distinct components to sign§ 11.200(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 Kaye's own pages. Ask Kaye for its validation documentation and test the control in your own validation before you rely on it.
Kaye's own Part 11 pageread 2026-10-22
XiltriX
monitoring- What it is
- A lab monitoring system that records sensor readings around the clock along with alarms, acknowledgements and configuration changes. XiltriX supplies the sensor network; this entry covers its record-keeping software only.
- Who it fits
- Blood banks, tissue establishments, labs and pharma QC with long record-retention obligations.
| Requirement | Status |
|---|---|
| Secure, computer-generated, time-stamped audit trail§ 11.10(e) | verified |
| Audit trail kept as long as the record§ 11.10(e) | stated |
| Access and authority checks by role§ 11.10(d), (g) | stated |
| Accurate, complete copies for inspection§ 11.10(b) | stated |
| Validation documentation to support the customer's own validation§ 11.10(a) | verified |
| Two distinct components to sign§ 11.200(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 XiltriX's own pages. Ask XiltriX for its validation documentation and test the control in your own validation before you rely on it.
XiltriX'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 an FDA-approved or certified temperature monitoring system?
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 a monitoring system means the vendor states its software supports the controls. You still validate it for your own use § 11.10(a), starting from the vendor's IQ/OQ material if it has any. The IQ OQ PQ template lays out the protocol.
Do the sensors and data loggers fall under Part 11?
Part 11 covers the electronic records and signatures. The probes and loggers are equipment: the drug CGMP and GLP rules want them calibrated under a written program, with records § 211.160(b)(4), § 58.63. The software that stores, alarms on and reports the readings is the computerized system you validate. Every card on this page covers that software only.
Does acknowledging an alarm need an electronic signature?
Not by itself. An acknowledgement is an operator action, so it belongs in the time-stamped audit trail § 11.10(e). The signature sections apply when your procedure makes an entry a signature, for example QA's review of an excursion: then it shows name, date and time and meaning § 11.50 and uses two components § 11.200(a). Vaisala notes that monitoring systems do not typically use electronic signatures for data review. Decide in your SOP which entries are signatures before you compare vendors on the signature rows.
We print a weekly chart and sign it on paper. Does the software still need Part 11 controls?
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. Once alarms are reviewed on screen, or the system holds the only complete data, it does. FDA recommends you document that decision, for example in an SOP.
How long do we keep monitoring data and its audit trail?
Part 11 sets no period of its own; the trail is kept as long as the record it covers § 11.10(e). The period comes from the predicate rule: for drug CGMP records tied to a batch, at least one year after the batch expires § 211.180(a); for GLP study records, the shortest of the periods in § 58.195(b), which also applies to equipment calibration records § 58.195(f).
Is a cloud monitoring system an open system?
It depends on who controls access, not on where the server sits: a closed system is one where access is controlled by the people responsible for the records § 11.3(b)(4). The open vs closed system check walks through it, and Part 11 for cloud and SaaS systems covers what to agree with the vendor.
Sources
Regulation text from the eCFR and EudraLex; guidance from FDA and PIC/S. Vendor sources are linked on each vendor card. General information, not regulatory advice.
- 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
- 21 CFR Part 211, CGMP for Finished Pharmaceuticals, eCFRread 2026-10-22
- 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, eCFRread 2026-10-22
- Part 11, Electronic Records; Electronic Signatures: Scope and Application (guidance, 2003), FDAread 2026-10-22
- Data Integrity and Compliance With Drug CGMP: Questions and Answers (2018), FDAread 2026-10-22
- EudraLex Volume 4, Annex 11: Computerised Systems (2011), European Commissionread 2026-10-22
- EudraLex Volume 4, Chapter 3: Premises and Equipment, European Commissionread 2026-10-22
- PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PIC/Sread 2026-10-22