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Software Validation and Compliance in Regulated Environments

ACD/Labs provides compliance-ready software for use in both GxP (good laboratory practice—GLP, good manufacturing practice—GMP) and CFR21 Part 11 compliant environments. We have supported numerous customers through the complicated process of validation and managed successful software audits.

Compliance for laboratory software systems means consistent and reliable results to assure quality, traceability, integrity, and validity.

How we do it

Software on the ACD/Spectrus Platform has been designed with features necessary for regulatory compliance. We can help with installation of our software and solutions in regulated environments and are happy to provide an advisory level of support based on our experience.

Validation

GxP Compliance features in Spectrus® Software:

CFR21 Part 11 Compliance

CFR21 Part11 compliance is necessary when you are sending electronic information directly from ACD/Labs software to regulatory authorities

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