Certos offers a part 11 compliant device management cloud as a white label solution
CertosCloud is a cloud-based device management cloud. GXP and Part 11 compliant automatic backup storage, data visualization, device configuration, and remote service.
Superior cloud solution
Frontend: React native
Backend: Java
Database: Choose between: PostgreSQL, MongoDB, Cadandra
The Certos HMI framework meets the requirements of FDA Part 11. It requires that the device manufacturer implements very secure software and controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data. For example:
– 21 CFR Part 11 compliance
– Encrypted databases
– Secure Network protocols (e.g. 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 authorized individuals
– Password expiration and reset
– Multilevel user roles
– Force complex passwords
– Password history
– User blocking techniques
– PDF signatures with single and double opt-in options
– Verification of individuals by RFID, Barcode, or password
– Secure timestamps
– Printouts according to GMP/GLP requirements
– Electronic Signature
CertosCloud supports a rich library of React UI components for lab equipment demands, and we are adding more all the time.
Stop reinventing the wheel and start using the Certos React UI framework to increase your productivity and reduce development time.
The rich widget library of Certos is useful for any laboratory equipment and scientific instruments. Additionally, you can easily add your widgets to the platform using your in-house capabilities
– User Management (Manufacturer Login, Service Login, End-Customer-Admin-Login, End-Customer Login)
– User Authorization
– Download of signed PDF reports
– Visual representation of the device internal data such as log files, audit trail, device configuration, device backups
– Real-time connection and statistics
– Data import and export via Excel or CSV
– Secure Backups of the laboratory device
– Cloud audit trail
API limitations
HTPPS2 protocol
SSL certificates
double-opt in option
Customizable token time limitations
Autoblock users
Behavior monitoring
The AI-part of the CertosCloud backend is written in python. Based on that programming language, the AI applications can run on different Machine Learning Algorithms. The best-performing algorithms are:
– Linear Regression.
– Logistic Regression.
– Decision Tree.
– SVM.
– Naive Bayes.
– kNN.
– K-Means.
– Random Forest
Certos Team found out that for Predictive Maintenance based on sensor data from internal components of laboratory equipment, the Random Forest algorithm shows the best performance yet.
The Cloud software can be installed on a local server using Docker. Installation takes 1 minute only. No internet is required.
The online cloud software can be used. No installation is required. The cloud is available at a custom domain such as
https://certosfrontend.herokuapp.com/
www.raypacloud.com
www.certocloud.com
https://lyncstore-ui.herokuapp.com/
OPTION 1: Remote control by humans manually:
Manual remote control via TeamViewer:
Certos Framework supports TeamViewer QuickSupport integration. This integration allows remote training, remote configuration, and remote service. The instrument enables remote screen sharing via Desktop PCs or mobile devices via CertosCloud.
Manual remote control via CertosCloud:
The CertosCloud web interface allows users to authenticate and to remote configure the device too. It is also possible to browse through the data of the laboratory device.
OPTION 2: Automated remote control by third party software:
CertosCloud comes with a REST-API and FTP, HTTP2 protocols that allow external software such as ERP systems or LIMS to send and receive data from the laboratory equipment in realtime and data history.
Certos can control multiple devices at the same time via the CertosCloud
Certos cloud comes with a standard communication protocol based on HTTP2, including Swagger-UI documentation. That means connecting the laboratory device to Laboratory Information Management Systems (LIMS) or other third-party software is easy. New protocols such as ANML and SILA2 are also supported. If a new communication standard arrives to market, it will be supported via a software update.