Radio HPLC software satisfies CFR Part 11

All LabLogic software implements the full requirements of the ruling in FDA 21 CFR Part 11 relevant to radio HPLC systems, as used by drug metabolism laboratories

Drug metabolism laboratories grappling with the implications of the FDA 21 CFR Part 11 for their radio HPLC systems can be confident that current versions of all LabLogic software implement the requirements of the ruling.

The enhancements the company has made, which were discussed at length with users before introduction, encompass the ADME laboratory information management system Debra; Laura, for data collection and analysis; Seescan (QWBA image analysis); Trace (genealogy method development); and Jane, for liquid scintillation counters.

All are classed as closed systems and the six controls defined by the FDA operate in accordance with CFR Part 11 in every case, as described in full on the website.

The key features can be as summarised as follows.

· Validation - unique instrument interface details validate raw data and ensure it came from the correct source.

· Security Controls - a combination of usernames and passwords ensures that only authorised individuals can use the system.

· Audit Trails - accurate and complete copies of records can be generated in both human-readable and electronic form.

· Electronic Signatures - each area that could require a signature is configurable, allowing a wide range of options for administrators without loss of compliance.

· Signature/Record Linking - when a user signs the details are recorded, and the signature cannot be transferred to another set of data.

· Identification Components - each user must have both a user name and a password, ensuring that at least two distinct identification components are employed.

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