AI in GMP systems: what the EU GMP draft Annex 22 means for your QMS and LIMS
What the EU GMP draft Annex 22 on artificial intelligence expects, what it means for AI in your QMS, LIMS and eBMR, and the questions to ask vendors.
Blog13 practical guides
Compliance — practical guides.
Practical guides for QA, QC, production and IT teams — written by the people who build Swat iQua Suite, for the people who run inspections.
Latest articles
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Data integrity findings in MHRA and FDA inspections — and how to avoid them
Common failures behind data integrity warning letters and MHRA findings — shared logins, deleted data, unreviewed audit trails — and how to prevent them.
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ALCOA+ explained with examples from the QC lab
ALCOA+ examples from the QC lab: what each data integrity principle means at the bench, the failures inspectors find and the controls that prevent them.
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21 CFR Part 11 checklist for electronic records and signatures
A practical 21 CFR Part 11 checklist: closed-system controls, audit trails, electronic signatures and passwords, and what the vendor vs your company owns.
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EU GMP Annex 1 (2022): a practical contamination control strategy checklist
A practical Annex 1 contamination control strategy checklist: what a CCS must cover, how to structure it, keep it current and show inspectors the evidence.
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Revised Schedule M: what Indian manufacturers must change, and how software helps
Revised Schedule M requirements in plain terms: the PQS, risk, PQR, validation and data integrity changes Indian plants must make, and how software helps.
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