"TotalLab's 21 CFR implementation is probably the best I've ever seen and administered on-site"
David Morton
Associate OT Specialist
Lonza
Could you sell more software or equipment if you were able to offer your customers 21 CFR Part 11/GMP compliance?
Are you a device manufacturer or software developer with an existing product you wish to launch into the lucrative pharmaceutical industry but are struggling to obtain compliance? Do you have an existing customer that needs a compliant version of your existing product?
TotalLab can help.
We’ve already had our software accepted by the regulatory departments of some of the world’s largest pharmaceutical companies, so we know exactly what they want in terms of features and usability beyond basic audit trails and other base-level requirements of 21 CFR Part 11/GMP regulations:
This means you can be confident that your final product will meet and exceed even the strictest regulatory requirements, ready for active use in industry.
Taking your existing product, be it existing software or instrumentation, and making it compliant can be a significant undertaking for a business – often requiring the investment of time, money and even potentially requiring the hiring of new specialist staff.
Here at TotalLab we already have an industry-proven solution that can be applied to your existing product, reducing time to market, business risk and the required upfront financial investment. We’ll work with you to support your entry into the market and help you and your sales teams understand the software and opportunities presented when working in regulated industries.
Our software is flexible enough to be wrapped around nearly any existing software or hardware, enabling OEMs a shortcut to gain access to the lucrative pharmaceutical or manufacturing markets with no regulatory knowledge required themselves.
We’re already trusted with providing compliant solutions for equipment/software developed by the following businesses:
"TotalLab's 21 CFR implementation is probably the best I've ever seen and administered on-site"
David Morton
Associate OT Specialist
Lonza
Our module complies by implementing the following features:
Our GxP Module eliminates project overwriting through our check-in/check-out system. This means that analysts can collaborate on a project, without risk of overwriting each other’s contributions, leading to a streamlined and easy-to-use process.
Our solution provides an easy-to-read, time-stamped audit trail which contains a complete history of projects created, retrieved and approved.
With our full analysis audit trail/report you can easily reproduce analyses.
The solution also comes equipped with an access log. This automatically tracks critical signature and system access actions such as:
All of this information is held to hand, so if called upon you can easily demonstrate your compliance through electronic reports.
21 CFR part 11.10(d) refers specifically to secure sign-ins and limiting system access to only authorised individuals. This includes controlling who can use the system, sign off a project and view and alter a record.
Our compliant system has the following features to enable users to meet compliance:
AuditSafe is TotalLab’s answer to one of the major pain points in introducing regulatory compliance in a manufacturing site – difficulty in integrating the solution within your existing network.
Here at TotalLab we’ve been creating and selling FDA 21 CFR Part 11/GxP-compliant software for the pharmaceutical and other regulated industries (such as hospitals) worldwide for years now with an incredibly robust and feature-rich software solution however the hardest part of the installation and validation of the software on site has always been navigating the existing users network/IT configuration.
From blocked ports to user permission headaches preventing end users from setting up the software themselves without their own IT professionals to hand, we thought there must be an easier way for our users to become compliant.