Role of Analytical Instrument Qualification in Data Integrity with 2017 USP <1058>
Regulated laboratories must demonstrate that the analytical instruments they use are suitable for their intended use, and performing AIQ is the best way to do this. A well implemented AIQ process reduces potential audit risks associated with laboratory instruments and safeguards the data they generate. If the instrument is not performing as expected, the analytical results generated may be invalid.
The changes to USP <1058> in the 2017 version are significant and require laboratories to fundamentally re-evaluate their AIQ processes, or risk regulatory non-compliance. The 2017 version contains many similarities to the 2008 version, and there is a risk that laboratories make the following erroneous interpretation:
“The changes appear to be small and evolutionary in nature; we already complied with <1058>, so the changes have minimal impact on our laboratory.”
Agilent’s white paper series highlights and explains changes in the 2017 version of USP <1058>, so that laboratories realize the impact of the changes and implement appropriate updates to their AIQ processes and procedures (or risk a potential non-compliance in a regulatory audit).
The third white paper highlights the role of AIQ in data integrity with the 2017 version of USP <1058> by providing information on:
- AIQ and Data Integrity <1058> - why AIQ is an important component of data integrity
- Laboratory Data Integrity - discussion of the 4-layer data integrity mode
- Compliance of Analysis - the impact of data integrity on analytical instruments and systems
- Operational Qualification -where user requirements are tested and verified
- Audit Findings - laboratory FDA and EudraGMDP data integrity findings
Part 1 : What Has Changed with the 2017 Version of USP <1058>?
Download Part 3 of our white paper series to learn how Agilent can help make your lab compliant with USP <1058>.
Please complete the form below to download.