The landscape for regulatory requirements is continually evolving, and inspectors are asking more and more questions about data. Keeping up with current and potential future requirements for audit review and data integrity is a never-ending challenge. If your pharma or biopharma QA/QC lab is seeking a way to have more confidence in data compliance, consider the latest release of Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS) (version 7.3.1), which enables you to meet the latest regulatory requirements while still improving productivity.
1. How can Chromeleon CDS alleviate your regulatory compliance concerns?
Compliance with regulatory requirements is critical for a business; yet it’s often regarded as something that can add significant cost to the company. With the acquisition of a chromatography data system (CDS) that provides all of the necessary functionality built-in to one easy-to-use package, the effort required to achieve compliance with 21 CFR Part 11 is significantly reduced.
2. What about audit trails?
Audit trails provide an accurate history that enables full traceability in the form of actions. Chromeleon CDS delivers extensive coverage, capturing the who, what, when and why, with powerful easy-to-use audit trail search capabilities that allow event reconstruction to maintain data integrity.
3. How does Chromeleon CDS help with validation?
Chromeleon CDS can help your validation efforts go smoothly with built-in Installation Qualification (IQ) and Operational Qualification (OQ) tools for the software as well as select Thermo Scientific hardware components. The built-in Performance Qualification (PQ) tools allow for periodic checks to verify that both software and hardware are working as intended.
4. Our lab has multiple users with different roles and access needs. How can Chromeleon CDS help?
It offers centralized administration through the Chromeleon Administration Console, which serves as the central access point for all administration tasks. This console manages users, roles, privileges and access control throughout your lab, while also allocating and controlling licenses at a global or organizational unit (e.g., site, lab, department) level. It also defines global policies with controlled devolution of admin tasks, and manages Chromeleon Domain resources including servers, PCs and printers.
5. Our lab is on a fast growth track. Is Chromeleon CDS scalable?
Yes. As a part of modern business IT system, Chromeleon CDS can easily scale to meet your needs, from a few PCs in a single lab to a large network that spans hundreds of instruments over multiple continents, while still allowing the control necessary to meet regulatory requirements.
6. What happens during a network outage? Will our data be protected?
Chromeleon Software provides a unique, resilient architecture to prevent data loss or corruption during network outage, tracking all actions and enforcing control to preserve the integrity of your data. Automatic Network Failure Protection (NFP) using unique XVault technology ensures continuous operation and data security should network or central resources become unavailable.
Download the eBook: Are you audit ready? Ensuring trustworthy data
White paper: Using Chromeleon 7 Chromatography Data System to Comply with 21 CFR Part 11
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