QFacts blog
Notes on document control, training and the work behind a well-run quality system.
What counts as a GMP deviation, what 21 CFR 211, EU GMP and ICH Q10 require, and how to record, contain, classify, investigate and close deviations in a way that stands up to inspection.
What small pharma, biotech and medical device teams actually pay for an eQMS: how vendors price, the prices that are public in October 2026, an illustrative ten-person example, and the implementation, validation and internal costs to budget for.
SharePoint can hold GMP documents, but approvals with signature meaning, effective dates, training before use and audit trail review are yours to build and validate. Here is what Microsoft 365 provides, what it leaves to you, and when an eQMS becomes worth it.
What makes a GMP change record traceable? The regulatory basis in EU GMP, ICH Q10 and Q9(R1), 21 CFR 211 and ISO 13485, the elements every record needs, and the gaps inspectors look for.
ISO 9001:2026 was published on 16 September 2026, with a transition deadline of 30 September 2029. Here is what was revised, what stayed the same, and what it means for your documents, management review and internal audits, with a transition checklist.
QFacts 1.4.0 introduces the Checklist Module. Build checklist templates once, get them reviewed and approved, and launch them by hand or on a schedule. Answers are graded automatically and every step is signed. Also new: saved filters, one Export menu for every table, and Microsoft sign-in.
