Nestlé
Food manufacturingUses:Mindlabs Anchor
Real-time temperature and humidity monitoring with alerts when any area goes out of range.
Compliance
21 CFR Part 11 Compliant Temperature Monitoring System
Mindlabs temperature and environmental monitoring is built for FDA-regulated environments — with electronic records, secure time-stamped audit trails, role-based access, and validation (CSV) documentation. Everything you need to support a 21 CFR Part 11-compliant monitoring programme across pharma manufacturing, cold chain, and laboratories.
Secure audit trails
Role-based access control
CSV validation documentation
Made in India
Part 11-Ready Across the Range
21 CFR Part 11
Anchor
GoAudit trail · Access control · CSV validatedPart 11-ready
The Regulation
What Is 21 CFR Part 11?
21 CFR Part 11 is the US FDA regulation governing electronic records and electronic signatures. It sets the requirements a computerised system must meet for its electronic records to be considered trustworthy, reliable, and equivalent to paper — covering data integrity, audit trails, access control, and system validation. For temperature monitoring, it means every reading, alarm, and change is captured, attributable, and tamper-evident, so your data holds up under inspection. It's also why auditors now ask who changed a setpoint, and when, not just whether every reading was logged.
Requirements
The Core Requirements
Electronic records
Accurate, complete, retrievable, and protected for the retention period.
Secure audit trails
Computer-generated, time-stamped logs of who did what and when, without obscuring prior data.
Electronic signatures
Unique to the individual, linked to the record, with name, date/time, and meaning.
Access & authority controls
System access limited to authorised users, with role-based permissions.
System validation (CSV)
Documented validation (IQ/OQ/PQ) that the system performs as intended.
Data integrity (ALCOA+)
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available.
How Mindlabs Supports Each Requirement
| 21 CFR Part 11 requirement | How Mindlabs supports it |
|---|---|
Electronic records | Temperature, humidity & environmental data captured and stored electronically — accurate, retrievable, and retained per your policy. |
Secure, time-stamped audit trail | Computer-generated audit trail logging configuration changes, user actions, and alarm acknowledgments, without overwriting previous entries. |
Electronic signatures | Not yet implemented — the platform provides electronic records, audit trails, and role-based access control under Part 11 today; e-signature support is on the roadmap. |
Access & authority controls | Role-based user accounts; only authorised users can view or change settings and thresholds. |
System validation (CSV) | IQ/OQ/PQ validation documentation available to support your Computer System Validation. |
Data integrity (ALCOA+) | Tamper-evident, attributable, contemporaneous records with original values preserved. |
Accurate copies | Export human-readable PDF and CSV, plus electronic copies, for audits and inspections. |
Record retention | Configurable retention with data available throughout the retention period. |
Time stamps (§11.10(e)) | Every reading and every user action is recorded with a computer-generated time stamp. |
Record protection and retention (§11.10(c)) | Data is stored on AWS so records can be retrieved accurately throughout the retention period. |
Data security (§11.30) | Data is encrypted on AWS. |
Compliance status, visible in real time
Every device's compliance state, audit trail activity, and alert history — tracked live from the Mindlabs cloud dashboard. For CROs that matters twice over: under ICH E6(R3), sponsors now audit your lab data as well as regulators.
https://app.mindlabs.cloud/dashboard
Live
How to Validate a Wireless Temperature Monitoring System for Part 11
Validating a wireless monitoring system follows the same risk-based approach as any GxP computerised system, with extra tests for the wireless link. A typical sequence:
- 1
User requirements: define what you monitor, where, alarm limits, who responds, and how long records must be kept.
- 2
Supplier assessment: review the vendor's quality system, software documentation and data security.
- 3
Risk assessment: identify what could compromise data or product (sensor failure, network loss, power cuts, unauthorised access) and set controls for each.
- 4
Installation qualification (IQ): confirm devices are installed as specified, calibration certificates are on file, and every device connects to the network.
- 5
Operational qualification (OQ): test alarms, audit trail entries, user roles and permissions, time synchronisation, and what happens when a device loses and regains its network connection.
- 6
Performance qualification (PQ): run the system under normal operating conditions and confirm it records and alerts as required.
- 7
SOPs and training: write procedures for alarm response, user access and data review, and train every user.
- 8
Periodic review: re-check the system on a set schedule and after any change to software, devices or locations.
Mindlabs provides CSV documentation to support your IQ and OQ. Your QA team owns the validation.
Which Mindlabs Products Are Part 11-Ready
Looking at the full range? compare all temperature data loggers and prices, or see the complete pharmaceutical temperature monitoring system.
Build a 21 CFR Part 11-Compliant Monitoring Programme
Talk to the Mindlabs compliance team about Part 11-ready monitoring and validation documentation for your regulated environment.
Customers
Trusted by 200+ Companies
Pharma, healthcare, food and logistics companies across India and worldwide.
Case Studies
Trusted by Pharma Quality Teams
Ferrero
Food manufacturingUses:Mindlabs Anchor
Real-time temperature and humidity monitoring with alerts when any area goes out of range.
Aurobindo
PharmaTemperature mapping of storage areas with Nova, and single-use PDF records on shipments with Lite Plus.
Biological E
Pharma & vaccinesUses:Mindlabs Nova
Temperature mapping of storage areas, with PDF and CSV reports for audits.
Celcius
Cold chain logisticsUses:Mindlabs Go
Live temperature, humidity and GPS tracking of shipments, with alerts on any excursion.
Gadre Marine
Seafood exportsReal-time monitoring at site and a PDF temperature record for every export shipment.
Transis Global (TGF)
Transis Global (TGF)
Freight & logisticsUses:Mindlabs Go
Live temperature, humidity and GPS tracking of shipments, with alerts on any excursion.
Jeelani
Jeelani
ShipmentsUses:Mindlabs Go
Live temperature, humidity and GPS tracking of shipments, with alerts on any excursion.
Algor
Algor
ShipmentsUses:Mindlabs Go
Live temperature, humidity and GPS tracking of shipments, with alerts on any excursion.
Aspiro
Apollo
Apollo
HospitalUses:Mindlabs Anchor
Real-time temperature and humidity monitoring with instant alerts to hospital staff.
KIMS
HospitalUses:Mindlabs Anchor
Real-time temperature and humidity monitoring with instant alerts to hospital staff.
AIG Hospitals
HospitalUses:Mindlabs Anchor
Real-time temperature and humidity monitoring with instant alerts to hospital staff.
Part 11 for Indian Exporters
If you export to the US, your electronic temperature records fall under 21 CFR Part 11 whenever FDA rules require that record. The same records also support two other frameworks Indian manufacturers work under:
- Revised Schedule M (G.S.R. 922(E)) brings Indian GMP closer to WHO GMP, including expectations for validated computerised systems and reliable records.
- EU GMP Annex 11 sets the equivalent rules for computerised systems for EU-bound products.
One validated monitoring system with audit trails, access control and complete records can support all three.
Frequently Asked Questions
It is the US FDA regulation on electronic records and electronic signatures, defining what a computerised system must do for its electronic data to be trustworthy and inspection-ready — covering audit trails, data integrity, access control, and validation.
There is no official Part 11 certification. Mindlabs is Part 11-ready: the system provides core capabilities — electronic records, audit trails, and access control — and the regulated user validates and operates it to achieve compliance.
A secure, computer-generated, time-stamped log of every relevant action — configuration changes, user access, and alarm acknowledgments — that cannot obscure previously recorded data.
Yes. Mindlabs provides IQ/OQ/PQ validation support documentation for regulated customers to underpin Computer System Validation.
A framework for trustworthy data: Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available.
Anchor and Go, backed by the Mindlabs cloud platform, provide electronic records, audit trails, and access controls that support a Part 11-compliant programme.
It applies to organisations that create, modify, or store electronic records for FDA-regulated activities — for example, pharma manufacturers and exporters to the US market. Your quality/regulatory team defines the scope for your operation.