Full compliance for 21 CFR part 11 and EU Annex 11 is supported now by LabX.
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. 21CFR Part 11 and EU Annex 11 are complex regulations, requiring technical, administrative and procedural controls to be implemented to ensure compliance. The regulations define the measures that must be in place to protect the integrity, trustworthiness and reliability of the electronic records.
LabX, together with the validation products and services offered by Mettler Toledo, can take you most of the way to reach compliance for 21 CFR part 11 and EU Annex 11. LabX has all the technical controls implemented making it compliance ready to support the lab to meet the regulations. Compliance for 21 CFR and EU Annex can be assured with only a few additional administrative and procedural controls.
In this white paper, the regulations are described in detail, including clarification on questions that a computerized system must answer, and concluding with an explanation of how LabX supports this specific compliance.