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.
Blog13 practical guides
Pharma quality and compliance, explained plainly.
Practical guides for QA, QC, production and IT teams — written by the people who build Swat iQua Suite, for the people who run inspections.
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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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What is a pharma LIMS? Features, compliance and how to choose (2026 guide)
What a LIMS for pharma must do: sample-to-CoA workflow, specifications, stability, data integrity and Part 11 controls — plus a checklist for choosing one.
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