/ Lab Management

Enabling Compliance in GxP Labs

TetraScience Lab Monitoring is now 21 CFR Part 11 ready

Author:
Salvatore Savo, Co-Founder, TetraScience

Since its inception, TetraScience's Lab Monitoring Application has been assisting the life sciences industry with monitoring of critical equipment. Our best-in-class Lab Monitoring Application is used by top global pharmaceutical and biotech organizations to monitor freezers and CO2 incubators. Over the years we have saved our customers millions of dollars and countless numbers of equipment and in potential losses.

What's new

Over the last several months, our team has been working tirelessly to take the product to the next level so that we could also add value to GxP labs. We are excited to announce that our Lab Monitoring Application is now 21 CFR part 11 ready and can enable your lab to be GxP compliant.

For decades, life science organizations have relied on paper based records as the only source of truth. With the advent of electronic records, the life sciences industry had to adopt guidelines to ensure that the digital data could be trusted. The 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records by the Food and Drug Administration (FDA).

These are some of the most relevant new product features and services that we have introduced:

  • Audit trail
  • Electronic signature
  • Session inactivity timeout
  • Multi-factor authentication
  • System validation and IQ/OQ/PQ
  • NIST traceable sensors
  • Annual sensors certification and calibration

Record Keeping and Auditability
The TetraScience Audit Trail chronologically catalogs events to provide support documentation and history used to authenticate operational actions. These records provide proof of compliance and operational integrity. These are the some of the critical elements contained in the audit records for each event:

  • Event description
  • User
  • Date & time of event

IMAGE: Example of an Audit Trail report in the TetraScience Lab Monitoring application
audittrail

Security
In order to enable the highest level of security and to prevent fraud, the TetraScience Lab Monitoring application supports multi-factor authentication. This adds a second layer of security to protect user accounts and personal information. Additionally, users will be asked to prove their identity by entering username and password when performing critical actions. Lastly, administrators have the possibility to require users to re-enter their credentials in case of prolonged inactivity using the dashboard.

Service
In addition to innovating the product, we have also introduced a new set of services that will allow us to fully support GMP and GLP labs with their monitoring needs. Contact us to learn more about our validation and sensor calibration programs.

Why this is important

Whether you are planning to build a new manufacturing facility or working in an existing one, you need to make sure to use the most reliable Lab Monitoring system on the market to keep your samples safe while being compliant. TetraScience Lab Monitoring combines the best-in-class cloud-based software user experience, with the most reliable hardware that supports 5GHz Wi-Fi, cellular, and hardwired connection, all built on an infrastructure that ensures your data is always accessible and never compromised, thus meeting your data integrity requirements.

What innovations we are bringing to the GxP world

Superior User Experience
The Lab Monitoring application is designed to be intuitive and easy to use. Whether you are monitoring one piece of equipment or hundreds of pieces of equipment, you'll be able to seamlessly integrate our monitoring system with your internal workflows.

Customer-centric
We work with you and your QA team through every step of the process, and are always available to assist you. Our modern dashboard includes a live chat feature for communicating with our customer support team in real time when you have questions or emergencies.

Low Onboarding Maintenance Overhead
Traditional monitoring systems require you to manage and configure the alerting system. We do everything for you, from equipment data entry and instrument naming to alert configuration.

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