Full restoration after a device failure
Quality control employees are delighted by full system and data restoration after device failure, leveraging Certos Cloud real-time backups.
Certos white label cloud
A Part 11 compliant device management cloud, under your brand
CertosCloud is a cloud-based device management platform: GxP and Part 11 compliant automatic backup storage, data visualisation, device configuration and remote service.
Superior cloud solution
Everything a device fleet needs, with your logo on it
Built around one key challenge: automatically fulfil the 21 CFR Part 11 and GMP requirements, and turn your lab equipment into a compliant solution.
State-of-the-art software stack
- Frontend
- React
- Backend
- Java
- Database
- Choose between PostgreSQL, MongoDB or Cassandra
- Analytics
- Python machine-learning services
21 CFR Part 11 compliance
The Certos framework meets the requirements of FDA Part 11, which requires the device manufacturer to implement very secure software and controls: audits, system validations, audit trails, electronic signatures and documentation for the software and systems that process the electronic data.
- 21 CFR Part 11 compliance
- Encrypted databases
- Secure network protocols (HTTPS, FTPS)
- System test reports according to FDA
- Secure electronic records
- Audit trail
- Verified accurate and complete data transfer
- Validated data integrity
- Device-specific encrypted data backups on external servers
- Limitation of access to authorised individuals
- Password expiration and reset
- Multilevel user roles
- Forced complex passwords
- Password history
- User blocking techniques
- PDF signatures with single and double opt-in
- Verification of individuals by RFID, barcode or password
- Secure timestamps
- Printouts according to GMP/GLP requirements
- Electronic signature
Widgets and self-help coding
CertosCloud supports a rich library of React UI components for laboratory equipment demands, and we are adding more all the time. Stop reinventing the wheel — use the Certos React UI framework to increase productivity and reduce development time.
The widget library is useful for any laboratory equipment and scientific instrument, and you can add your own widgets to the platform using your in-house capabilities.
Default cloud features
- User management: manufacturer login, service login, end-customer admin login, end-customer login
- User authorisation
- Download of signed PDF reports
- Visual representation of device internal data such as log files, audit trail, device configuration and backups
- Real-time connection and statistics
- Data import and export via Excel or CSV
- Secure backups of the laboratory device
- Cloud audit trail
High security of the cloud service
- API limitations
- HTTP/2 protocol
- SSL certificates
- Double opt-in option
- Customisable token time limitations
- Auto-block users
- Behaviour monitoring
Machine-learning based analytics
The AI part of the CertosCloud backend is written in Python, so the applications can run on different machine learning algorithms. The best-performing ones are linear regression, logistic regression, decision tree, SVM, naive Bayes, kNN, k-means and random forest.
For predictive maintenance based on sensor data from internal components of laboratory equipment, the Certos team found that the random forest algorithm shows the best performance yet.
Cloud or on-premise
The cloud software can be installed on a local server using Docker. Installation takes one minute, and no internet connection is required.
Alternatively the online cloud can be used with no installation at all, available on a custom domain of your choosing.
Remote access via tablet and smartphone
Option 1 — remote control by humans. The framework supports TeamViewer QuickSupport integration for remote training, configuration and service, with screen sharing from desktop or mobile. The CertosCloud web interface also allows users to authenticate, configure the device remotely and browse its data.
Option 2 — automated remote control by third-party software. CertosCloud comes with a REST API plus FTP and HTTP/2 protocols, so ERP systems or a LIMS can send and receive real-time and historical data from the laboratory equipment.
Controlling multiple devices
Certos can control multiple devices at the same time via CertosCloud.
Connectivity with external devices
Certos Cloud comes with a standard communication protocol based on HTTP/2, including Swagger UI documentation, so connecting the laboratory device to a LIMS or other third-party software is easy. New protocols such as AniML and SiLA2 are also supported, and any new communication standard arriving on the market will be supported via a software update.
End-user value
Certos delivers significant value to end users
Configure devices without walking to them
Laboratory staff can remotely configure devices via Certos Cloud, with no need to travel and spend countless hours in the lab.
All device data behind one REST API
IT admins have all connected device data easily accessible via REST API, leading to rapid system integration and maintenance.
Compare the real process to the SOP
Quality assurance staff are in control, using process mining to its full potential to compare the working process to the SOP.
Feature set
Certos white-label cloud features
Book a free consultation
Are you in the development or production phase for a pharma or industrial product?
Let’s talk about the opportunities for collaboration. The first consultation is free — bring your specification, your existing controller, or just an idea.