FDA 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Qualtrax is designed with the Technical Controls necessary for 21 CFR Part 11 compliance. The closed system provides robust electronic document and record control, revision tracking, electronic signatures, and audit trails. No software vendor can offer a certified FDA compliant solution, since it is the responsibility of the user to implement the Procedural and Administrative Controls to ensure overall Part 11 compliance. However, Qualtrax does offer services and tools to help with this process.
Qualtrax meets FDA 21 CFR Part 11 technical requirements with the following features:
Qualtrax provides tools and services to help implement the necessary procedural and administrative controls for FDA compliance. The FDA Compliance functionality includes:
Download the FDA Compliance Document using the button below.
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