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Switching to a fully-set-up workspace no longer gets silently overridden by a half-configured one when the auth token refreshes or you navigate back to /app.

• fixedFixed a bug where selecting a configured workspace (e.g. Naeem Bakery), navigating away, and returning to /app would auto-switch you back to a workspace still on the Industry & Compliance setup step — and then redirect to /app/setup/industry. The membership loader was reading a stale tenant id from the initial render, so token refreshes overwrote your choice.
• improvedWhen the app has to pick a default workspace (e.g. your stored choice no longer exists), it now prefers a workspace that has an industry configured over one still in setup, so you never get stranded mid-onboarding.

Hide zero / negative / expired / blocked stock with one click, see when each lot was received and how old it is, sort FEFO/FIFO/qty, and export the current view as CSV.

• newToggle pills above the list: Hide zero, Hide negative, Hide expired, Hide blocked (quarantine/on-hold/rejected), Only near-expiry (≤60d), Only below reorder point. Defaults to 'Hide zero on'. Preferences persist per tenant in this browser.
• newBy Lot table now shows Received date + age (days on hand), Expiry with days-to-expiry, and Supplier / supplier lot reference inline — the columns operators actually ask for during a cycle count.
• newSort menu (FEFO / FIFO / Qty ↓ / Qty ↑ / Item code / Last movement). Applies across all three views.
• newExport CSV button writes the currently filtered + sorted view to a dated file with warehouse, location, item, lot, supplier, status, received, age, mfg, expiry, days-to-expiry, qty, unit cost and extended value — one file you can hand to finance for an ad-hoc stock take.
• newRow kebab menu on each lot line with quick links to the kiosk Move flow and the item record. Edit-expiry and adjust-qty (with e-signature) are coming in the next release.

When an import finishes 'partial', open the run from History to see exactly which rows failed and why, and download them as a fix-and-reupload CSV.

• newEvery CSV run with a failed count now has a 'View failed' button in History → opens a dialog listing each rejected row with row number, error message and the original payload.
• new'Download failed rows (CSV)' inside the dialog exports just the rejects (with _row and _error columns prepended) so you can fix them in Excel and re-upload, instead of re-uploading the whole file.
• improvedRetry failed and View failed sit side-by-side on every partial run so the recovery path is one click instead of digging through logs.

Import opening on-hand stock from CSV. Resolves item + bin + lot, writes a reconciliation adjustment so the ledger and balance stay consistent.

• fixedCSV import of the Inventory entity used to finish silently with 0 rows persisted (no per-row error visible). The inventory upserter is now implemented end-to-end.
• newInventory import resolves item by item_code, bin by location_code, creates the lot if lot_number is new (status = released, optional expiry / manufacture date), then posts an 'adjust' inventory_transaction equal to (csv qty − current on-hand) so on_hand_inventory rolls forward via the existing ledger trigger.
• improvedRows where qty already matches are reported as updated (no-op) instead of silently skipped, so reconciliations show the true delta.

For shops with no ERP: project finished-good demand from work-order history, explode through formulas, see what to buy by vendor.

• newDemand forecast at Planning → Demand forecast — 13-week trailing average + trend vs the prior 13 weeks, projected 4 / 8 / 13 / 26 weeks ahead per SKU, with a rough MAPE confidence band.
• newMRP at Planning → MRP requirements — explodes the forecast through each finished good's approved formula, nets against on-hand + open POs + safety stock, groups net requirements by preferred vendor, and drafts a PO per vendor in one click.
• improvedBoth run on data you already have — work orders, formulas, inventory, vendors. No ERP feed required.

Lightweight project management built in. Track CAPAs, NPI, validation rollouts, kaizen and any cross-functional work without leaving V5.

• newNew Projects hub at Team & Roles → Projects. Create projects with status, due date and colour; tasks live inside each project.
• newThree views per project: Kanban (drag tasks between To-do / In-progress / Blocked / Done), Gantt (timeline with start + due dates) and List.
• newLightweight by design — no e-signature required to close a task, so it works for internal improvement work as well as bigger initiatives.

One-click translation of every public page (home, industries, pricing/ordering, glossary, compare) into 25 languages.

• newFloating language picker (bottom-left) on every marketing and ordering page — Spanish, French, German, Italian, Portuguese, Polish, Dutch, Japanese, Korean, Chinese, Arabic and more.
• improvedPrices already render in the visitor's local currency with tax — now the surrounding copy translates too, matching the experience on sgsystemsglobal.com.

Closed five security findings across realtime, storage, AI-generated HTML, and the ERP cron endpoint.

• fixedRealtime channel subscriptions are now scoped to your workspace — other tenants can no longer listen in on work-order, signoff, deviation, or lot activity.
• fixedBrand assets in storage are now readable only by members of the owning workspace, matching upload/edit rules.
• fixedAI-generated audit briefings and prospect email bodies are sanitized with DOMPurify before render, eliminating stored XSS via prompt-injected HTML.
• fixedThe ERP job-queue cron endpoint now requires a dedicated CRON_SECRET; the public publishable key is no longer accepted.

Wave 101 — the sterile-process + validation-lifecycle spine: Media fill / APS (Annex 1 §9.32-§9.46 + USP <1116> + PDA TR-22/TR-28 + intervention-register coverage + zero-positive 2022 expectation + per-operator gowning qualifier + product-impact-back-to-last-good-APS), Moist-heat sterilization validation (ISO 17665-1 + EN 285 + USP <1229.1/.2> + overkill/bioburden/half-cycle + F0 cold-spot + Bowie-Dick daily check + saturated-steam-quality + pulsed vacuum), ICH Q3B(R2) drug-product degradation impurities (RT/IT/QT keyed off MDD + qualification routes + M7 mutagenic overlay + Q1A stability interaction), Lyophilization validation (Tc/Tg'/Te + Pikal heat-mass model + design space + edge-of-failure + per-position residual moisture + dryer-to-dryer Kv characterisation), USP <790>/<1790> visual inspection of injectables (binary 'essentially free' + 2000-3750 lux + black+white background + 10-20s viewing + Knapp test inspector qualification + AQL release + automated Eisai/Bosch systems), and EU GMP Annex 15 qualification + validation umbrella (URS→DQ→IQ→OQ→PQ + traditional/continuous/hybrid PV + cleaning + transport + CSV + revalidation + change-control + periodic review).

• newPillar pages for Media fill / Aseptic Process Simulation, Moist-heat sterilization validation, ICH Q3B(R2) drug-product impurities, Lyophilization validation, USP <790>/<1790> visual inspection of injectables, and EU GMP Annex 15 qualification + validation umbrella — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.571.

Wave 100 — the sterile / aseptic / cross-contamination control spine: ICH Q3A(R2) drug-substance impurities (RT/IT/QT thresholds tied to max daily dose + qualification ladder + M7 mutagenic overlay), EU GMP Annex 1 (2022 revision — CCS Contamination Control Strategy + Grade A/B/C/D + isolators/RABS + media fills + PUPSIT + single-use systems), Microbial identification (MALDI-TOF + 16S/ITS sequencing + objectionable-organism judgement + in-house isolate library), Container-closure system qualification (USP <659>/<660>/<661>/<671>/<381>/<1207> + E&L + Q1A stability-by-CCS + bridging stability on change), Pharmaceutical water systems (PW / WFI / WFI by membrane post-2017/2019 + turbulent flow + 3D dead-leg + ozonisation + Phase 1/2/3 qualification), and Cleaning validation MAC (10 ppm / 1/1000 / HBEL per EMA 2014 + PIC/S PI 046-1 + worst-case bracketing + DHT/CHT + three-run contract).

• newPillar pages for ICH Q3A(R2) drug-substance impurities, EU GMP Annex 1 (2022) sterile manufacture, Microbial identification, Container-closure system qualification, Pharmaceutical water systems (PW/WFI), and Cleaning validation MAC/HBEL — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.570.

Wave 99 covering oral-solid-dose unit operations, dissolution, recall hazard tiers, label-claim litigation and the ICH stability backbone: Tablet compression (rotary-press CPPs + dwell time + capping/lamination/sticking + TSM/EU tooling + §111.70(e) finished-product-spec linkage), Fluid-bed granulation (5 CPPs + LOD endpoint + NFPA 654 / ATEX explosion overlay + spray-rate-per-plate-area scale-up), USP <2040> Disintegration & Dissolution of Dietary Supplements (decision tree + apparatus/media + S1/S2/S3 stage-wise acceptance + multi-ingredient/probiotic/fat-soluble edge cases), FDA recall classification (Class I/II/III + market withdrawal vs stock recovery + Part 7 framework + 24/72-hour clocks + Level A/B/C effectiveness checks), 'Natural' claim (FDA 1991 informal policy + USDA FSIS definition + UDAP class actions + CLRA/FAL/§17533.7 + reasonable-consumer survey defence), and ICH Q1A(R2) Stability (long-term/intermediate/accelerated + climatic zones I–IVb + 3-batch primary + Q1B photostability + Q1D bracketing/matrixing + Q1E shelf-life assignment).

• newPillar pages for Tablet compression (supplements), Fluid-bed granulation, USP <2040> Disintegration & Dissolution, FDA recall classification (Class I/II/III), 'Natural' claim (supplements), and ICH Q1A(R2) stability storage conditions — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.569.

Wave 98 covering the next ring of supplement / food-manufacturer high-intent topics: FDA 483 response (15-business-day window + Warning Letter escalation ladder + per-observation anatomy), Mock recall program (GFSI 4-hour reconciliation + Walmart / Costco 2-hour scorecards + scenario-design discipline), Gluten-free labeling (21 CFR 101.91 + 20 ppm threshold + R5 ELISA Mendez + wheat-starch trap + oats), Softgel encapsulation (rotary-die CPPs + gel-fill compatibility + cross-linking + per-die statistics), Food facility registration (§415 + biennial renewal 1 Oct – 31 Dec even years + U.S. agent + §301(dd) exposure), and Kosher / halal certification (OU / OK / Star-K / KOF-K / IFANCA / JAKIM / GSO 2055 + ingredient + equipment + mashgiach + label control).

• newPillar pages for FDA 483 response, Mock recall program, Gluten-free labeling, Softgel encapsulation, Food facility registration, and Kosher / halal certification — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.568.

Wave 97 supplement-manufacturer pillars: Tamper-evident packaging (§211.132 + §111.430 + post-Tylenol regime + retailer-shelf gating), Pesticide residue (USP <561> + EPA tolerances + Codex MRLs + multi-residue LC-MS/MS panels), Mycotoxin control (aflatoxin / OTA / fumonisin / DON / ZEN / citrinin + AOAC 977.16 composite sampling + storage humidity), Stability-indicating method (ICH Q2(R2) + forced degradation + peak-purity confirmation), Master + Working cell bank (ICH Q5A/Q5D two-tier banking for probiotic strains), and Reportable Food Registry (21 U.S.C. §350f SAHCODHA + 24-hour clock + §301(e) strict-liability exposure).

• newPillar pages for Tamper-evident packaging, Pesticide residue, Mycotoxin control, Stability-indicating method, Master/Working cell bank and Reportable Food Registry — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.567.

Wave 96 supplement-manufacturer pillars covering the next layer of high-intent buyer questions: Allergen statement & cross-contact (FALCPA 2004 + FASTER Act sesame + 117 Subpart C cross-contact controls + #1 recall category), Probiotic CFU labelling (USP <2750> + first-order decay math + strain-level identity + worst-strain-governs overage), Toll manufacturing (§111.12 re-allocation when brand supplies components + CM identity-test obligation survives), Pure & highly concentrated caffeine (2018 FDA guidance + 0.4% / 0.01% safe-harbour thresholds + 2014-2018 overdose trigger), Botanical extract characterization (standardised vs full-spectrum DER + multi-assay identity stack + marker-spiking trap), Adulteration (§402) vs misbranding (§403) (two FFDCA enforcement pathways + overlap cases + remediation routing), and Qualified health claim (Pearson v. Shalala + LOED programme + non-paraphrasable qualifying language).

• newPillar pages for Allergen statement & cross-contact (supplements), Probiotic CFU labelling, Toll manufacturing (supplements), Pure & highly concentrated caffeine, Botanical extract characterization, Adulteration vs misbranding, and Qualified health claim — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.566.

Wave 95 supplement-manufacturer pillars covering the high-intent topics that sit alongside Part 111: NSF Certified for Sport + Informed Sport (WADA/NCAA/league panels + per-lot testing + facility audit), Microbial limits (USP <2021>/<2022>/<2023> + matrix-tier limits + probiotic selective-method trap + USP <1223> rapid-method validation), USDA Organic (7 CFR Part 205 + four labelling tiers + National List + 2024 SOE rule), Subpart K laboratory operations (§§111.303–.325 + USP <1058> instrument tiering + outsourced-lab management), Class-action exposure (slack-fill 21 CFR 100.100 / Cal §17533.7 + protein-spiking / Kjeldahl exploit + 'natural' UDAP cases), and Third-party cGMP audit (NSF/ANSI 173 + NPA + USP Verified + UL — programme comparison + audit cycle + brand-side use).

• newPillar pages for NSF Certified for Sport, Microbial limits (supplements), USDA Organic (supplements), Subpart K laboratory operations, Class-action exposure and Third-party cGMP audit — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.565.

Wave 94 supplement-manufacturer pillars targeting the highest-intent buyer questions a contract manufacturer or brand owner asks before an FDA inspection: Botanical authentication (111.75(a)(1)(i) orthogonal-method requirement + HPTLC + microscopy + DNA + reference-standard chain + ABC-AHP Adulterants watchlist), Heavy metals (USP <2232> + Prop 65 + ICP-MS + per-serving math + matrix-risk catalogue), Own-label distributor (§111.12(a) bilateral compliance + quality-agreement structure + Amazon-FBA trap), Contract manufacturer (§111.12 bilateral + brand-portal economics + 2016 QA guidance), Prop 65 (Cal H&S 25249.5 + MADL/NSRL + 2018 warning rewrite + bounty-hunter enforcement), EMA (FSMA §117.130 + IA Rule distinction + four supplement-specific patterns + VACCP scoring + commodity-price-spike trigger), and cGMP Warning Letter (top-10 Part 111 citation patterns + 483 response anatomy + 5 root-cause patterns + V5-to-citation map).

• newPillar pages for Botanical authentication, Heavy metals (supplements), Own-label distributor, Contract manufacturer (supplement), Prop 65, Economically motivated adulteration and cGMP Warning Letter (supplement) — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.564.

Wave 93 supplement-manufacturer pillars covering foundational statute + the four remaining Part 111 subparts most cited in 483s: DSHEA 1994 (PL 103-417 + §201(ff) definition + burden-of-proof shift + Oct 15 1994 grandfather line + three-tier claims + cGMP authority + 2006 DSNDCPA gap-close), Supplement stability & shelf-life (111.70(e) + 111.260(j) + 111.210(e) overage link + ICH Q1A-adapted protocol + active-loss table + container-closure dependence), Returned supplements 111 Subpart N (§§111.503–535 QC authority + quarantine + salvage assessment + reprocessing MMR + §111.525 investigation trigger), Packaging & labelling 111 Subpart H (§§111.410–430 line clearance + label issuance + reconciliation variance + re-labelling = manufacturing op), Holding & distribution 111 Subpart M (§§111.453–465 conditions + FEFO + reserve-sample storage + consignee records + recall readiness), Sanitation & physical plant 111 Subpart C (§§111.15–35 plant + SSOP + pest trending + water + equipment + §111.30 CSV + personnel hygiene).

• newPillar pages for DSHEA 1994, Supplement stability & shelf life, Returned supplements (111 Subpart N), Packaging & labelling (111 Subpart H), Holding & distribution (111 Subpart M) and Sanitation & physical plant (111 Subpart C) — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.563.

Wave 92 supplement-manufacturer pillars targeting label, import, post-market, and the supplement-specific MMR — all high buyer-intent topics distinct from Part 211 drug analogues: Supplement Facts panel (21 CFR 101.36 + 2016 DV overhaul + Class I/II tolerances + Latin binomial + plant part), Structure/function claim (DSHEA §403(r)(6) + 101.93 disclaimer + 30-day notification + FTC substantiation + 10 disease-claim criteria), Proprietary blend (101.36(c) carve-out + amount-spiking class-action pattern + DV-bearing breakout + retailer full-disclosure policies), FSVP (21 CFR Part 1 Subpart L + hazard analysis + supplier evaluation + verification activities + FSVP vs Part 111 vs Part 211 stack), Supplement AE reporting (DSNDCPA 2006 + §761 + MedWatch 3500A + 15-business-day clock + 6-year retention), MMR 111.205/111.210 (separate MMR per batch size + two-person approval + 12 required content elements + Part 111 vs Part 211 differences), and Component specs 111.70(b) (identity/purity/strength/composition/contamination + 111.75 verification + CoA reliance trap + USP <2232> heavy-metals floor).

• newPillar pages for Supplement Facts panel, Structure/function claim, Proprietary blend, FSVP, Supplement AE reporting, MMR (111.205/111.210) and Component specs (111.70(b)) — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.562.

Shipped supplement-specific pillar pages tuned to the highest buyer-intent 21 CFR Part 111 pain points: Identity testing 111.75(a)(1)(i) (per-lot dietary-ingredient identity, CoA-is-not-enough, FTIR/HPTLC/DNA methods, §111.75(a)(1)(ii) petition reality), Scientifically valid method 111.320 (ICH Q2(R2) + USP <1225>/<1226> verification, fitness-for-matrix, method transfer, system suitability), Reserve sample 111.83 + 111.95 (per-ingredient + per-batch retention, container-closure, 1-year past shelf-life / 2-year no-expiry rule), NDI notification §413 / 21 CFR 190.6 (75-day premarket safety, 'food supply' exemption, master-file strategy, FDA objection-letter reality), Quality Control unit 111.105 + Subpart F (independence, disposition authority, two-person e-sig, small-firm overlap patterns), and Finished product specifications 111.70(e) (five attribute categories, assay window justification, contamination panel by matrix, 111.75(c) sampling-plan path). Each maps to a concrete Warning-Letter pattern and a specific software-buying trigger.

• newPillar pages for Identity testing (111.75), Scientifically valid method (111.320), Reserve sample (111.83/111.95), NDI notification, QC unit (111.105) and Finished product specs (111.70(e)) — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.561.

Shipped pillar pages for NRC (10 CFR 19/20/30/35 + Agreement States + Part 35 medical-use AU/ANP/RSO + written directive + medical-event reporting + Part 37 source security + NRC vs FDA boundary), Cell & Gene Therapy manufacturing (21 CFR 1271 + 600/610 + EU ATMP Reg 1394/2007 + GMP Part IV + autologous chain-of-identity + viral vector + potency/comparability + Annex 1 facility + rapid-sterility conditional release), CMO/CDMO management (ICH Q7 §16 + EU GMP Ch 7 + 21 CFR 200.10(b) + FDA 2016 Quality Agreement guidance + RACI + scorecard + release models + filing triggers), Risk matrix (ICH Q9(R1) 2023 + ISO 14971 + ISO 31000 + scale anchoring + Cox/Hubbard critique + range compression + risk reversals), WO (ISA-95/88 + 211.188 mmr_snapshot rule + lifecycle state machine + kiosk interlocks + industry-profile terminology + lot genealogy), and Yield reconciliation (211.103 + 211.186(b)(7) + 211.192 + permissible variance bands + step-level vs final + net/gross tare governance + unaccounted-material trigger).

• newPillar pages for NRC, Cell & Gene Therapy manufacturing, CMO/CDMO management, Risk matrix, WO and Yield reconciliation — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.560.

Shipped pillar pages for ALARA (10 CFR 20.1003 + NRC RG 8.10 + ICRP 103 + time/distance/shielding tools + administrative investigation & action levels + dosimetry programme + radiopharmacy workflow), Half-life (NIST/ICRP 107 decay data + 17 medical isotopes + calibration-time anchor + decay-in-storage > 10 t½ + parent–daughter generators), Decay correction (A(t)=A₀·e^(−λt) + worked FDG example + EOB→EOS→bulk→unit-dose→administered reconciliation + Bateman for generators + ±5–10 % tolerances), SOC 2 (AICPA Trust Services Criteria 2017/2022 + Type 1 vs Type 2 + 9 Common Criteria + carve-out vs inclusive sub-services + CUECs + SOC 2 vs ISO 27001 vs Part 11), SSO/SAML (SAML 2.0 + OIDC + SCIM lifecycle + step-up MFA for Part 11 11.200 + break-glass + IdP-initiated CSRF traps), and RBAC (NIST ANSI INCITS 359-2004 + hierarchical + constrained + static & dynamic SoD + least privilege + training-gate + joiner/mover/leaver + V5 default role catalogue).

• newPillar pages for ALARA, Half-life, Decay correction, SOC 2, SSO/SAML and RBAC — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.559.

Shipped pillar pages for Allergen control (9 US allergens incl. sesame under FASTER Act + EU FIC 14 + 21 CFR 117.135(c)(2) + validated cleaning + label control + rework discipline), SSOP (USDA-FSIS 9 CFR 416 + FDA 21 CFR 117.35/117.135 + pre-op + operational + monitoring vs verification + record retention), TACCP/VACCP (PAS 96 + FSMA IA 21 CFR Part 121 KATs + GFSI mandate + anchored scoring + authenticity testing), MedWatch (Form 3500/3500A + device MDR 30/5-day clock + drug ADR 15-day + DSNDCPA + eMDR / FAERS / MAUDE / CAERS), CMMS (21 CFR 211.67/211.68 + 820.70(g) + ISO 13485 §6.3 + equipment-status interlock + calibration as-found/as-left + PM strategy + incumbent-CMMS sync), and HIPAA (45 CFR Parts 160/162/164 + HITECH + Privacy/Security/Breach rules + NIST SP 800-66 Rev 2 + BAA flow-down + HIPAA-vs-Part-11 distinction). ~1 short entry left in the queue.

• newPillar pages for Allergen control, SSOP, TACCP/VACCP, MedWatch, CMMS and HIPAA — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.558.

Shipped pillar pages for Design verification & validation (21 CFR 820.30(f)(g) + ISO 13485 §7.3.6/§7.3.7 + EU MDR Annex II §6 + V-model trace + HF validation interlock), DQ (EU GMP Annex 15 §3.2 + GAMP 5 V-model + URS→FS/DS coverage + supplier-vs-customer split + SaaS delta-DQ), FS (GAMP 5 Cat-4 baseline + customer-addendum + Part 11 / Annex 11 §9 behavioural spec + OQ-traceable), Human factors (IEC 62366-1:2015/AMD 1:2020 + FDA 2016 HF guidance + use-spec + task analysis + critical tasks + formative + ≥15 summative + ISO 14971 feedback), Predicate device (21 CFR 807.92 + FDA 2014 SE guidance + 2023 best-practices draft + SE decision tree + no split-predicate + reference-device rule), and PCQI (21 CFR 117.155 + FSPCA PCHF curriculum + reserved activities + 7-day record review + 3-yr re-analysis + Food Safety Plan + supply-chain program). ~7 short entries left in the queue.

• newPillar pages for Design verification, DQ, FS, Human factors, Predicate device and PCQI — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.557.

Shipped pillar pages for USP (FD&C §501(b) enforceable compendium + General Notices + chapter-number tiers + PDG harmonisation + USP RS lifecycle), BOM (EBOM/MBOM/planning/phantom/costed + 21 CFR 211.186 / 820.181 / 111.205 regulated-formula discipline + WO-release snapshot), FPY (per-step yield + RTY compounding + hidden factory + DPMO/sigma), RFT (batch-level Right First Time + leading-indicator for Stage-3 + ICH Q10 management-review headline metric), Fishbone/Ishikawa (6-M brainstorm tool + ICH Q9(R1) Annex I.4 + RCA-tool-chain pairing with 5 Whys / FTA / Pareto), and HARPC (FSMA 21 CFR 117 Subpart C + PCQI + 5 preventive-control categories + 7-day record review + 3-year reanalysis). ~13 short entries left in the queue.

• newPillar pages for USP, BOM, FPY, RFT, Fishbone (Ishikawa) and HARPC — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.556.

Shipped pillar pages for Traceability matrix (GAMP 5 + Annex 11 §4 + FDA CSA forward + reverse trace + device-software IEC 62304 risk-control trace), OEL/OEB (5-band ladder + HBEL/PDE sibling derivation + SafeBridge SMEPAC containment evidence + air + biological monitoring), Pp/Ppk (σ_overall vs σ_within + Cpk-Ppk gap diagnostics + Western Electric/Nelson rules + non-normal handling), 8D (Ford TOPS 8-step + occurrence + escape dual root cause + D6 effectiveness verification + D7 yokoten cascade), API (ICH Q7 GMP + Q11 starting-material designation + Q3/M7 impurity programmes + DMF/CEP/FMD supply chain), and Excipient (IPEC-PQG + EU 2015/C 95/02 risk-based GMP + IID + nitrosamine source-3 + ICH Q3D elemental contributions). Also fixes a latent wiring bug — Wave 80 (Cp/Cpk, PPQ, CPV, Tech transfer, Gage R&R, MSA) had imports but was missing from the LONGFORM_ENTRIES array, so those six pillars weren't reachable; now wired. ~19 short entries left in the queue.

• newPillar pages for Traceability matrix, OEL/OEB, Pp/Ppk, 8D, API and Excipient — each renders the long-form layout.
• fixedWave-80 pillars (Cp/Cpk, PPQ, CPV, Tech transfer, Gage R&R, MSA) were imported but not registered — now wired into the long-form registry.
• improvedSoftware version — bumped to v5.10.001.555.

Shipped pillar pages for APR/PQR (21 CFR 211.180(e) + EU GMP Ch.1 §1.10 12-item input list + trending discipline + repeat-cause analysis), EU GDP (2013/C 343/01 ten-chapter framework + RP + FMD/EMVS + Chapter 7 Quality Agreements), Cold-chain validation (ISTA 7D/7E + WHO TRS 961 + passive vs active + lane qualification + excursion vs stability budget), Temperature mapping (warehouse/chamber/vehicle qualification + worst-case probe placement + alert/action two-tier alarming), Supplier qualification (ICH Q9 risk tiering + audit + three qualifying lots + EU GMP Ch.7 Quality Agreement), USP <788> (Method 1 LO + Method 2 microscopic + SVP/LVP limits + OOS not retest), and Process validation (FDA 2011 Stage 1/2/3 lifecycle + Annex 15 envelope). Added seven short stubs for A–Z indexing. ~25 short entries left in the queue.

• newPillar pages for APR/PQR, EU GDP, Cold-chain validation, Temperature mapping, Supplier qualification, USP <788> and Process validation — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.554.

Shipped 4,000-word pillar pages for Extractables & Leachables (USP <1663>/<1664> + BPOG single-use), CCIT (USP <1207> deterministic methods + MALL + Annex 1 §8.22), Sterility (USP <71>/<1208>/<1223> + RMM + isolator), Endotoxin (USP <85>/<86> LAL + rFC + K/M formula), Bioburden (USP <61>/<62>/<1111> + ISO 11737-1) and ICH M7 (DNA-reactive impurity 5-class framework + TTC + cohort-of-concern AIs). Added six short stubs so they're indexable from the A–Z. ~32 short entries left in the queue.

• newPillar pages for E&L, CCIT, Sterility, Endotoxin, Bioburden and ICH M7 — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.553.

Shipped 4,000-word pillar pages for QbD (ICH Q8(R2) — QTPP / CQA / CMA / CPP / design space / control strategy), PAT (FDA 2004 framework — process analysers + chemometric model lifecycle + RTRT), Design space (Q8(R2) §2.4 — multivariate vs PARs + edge-of-failure + Q12 lifecycle), Control strategy (ICH Q10 + Q11 §6 — material/process/IPC/facility/finished/monitoring/change-control), ICH Q3D (R2 elemental impurities — 4 classes + PDEs + Options 1/2a/2b/3 + USP <232>/<233>) and Nitrosamines (EMA Art. 5(3) + FDA 2021/2024 + ICH M7 AI + NDSRI source-4). Added six short stubs so they're indexable from the A–Z. ~38 short entries left in the queue.

• newPillar pages for QbD, PAT, Design space, Control strategy, ICH Q3D and Nitrosamines — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.552.

Shipped 4,000-word pillar pages for Cleaning validation (HBEL/PDE-derived MACO, swab + rinse + recovery factors, DHT/CHT/campaign-length, ASTM E3106 lifecycle), Stability programme (ICH Q1A(R2) conditions, Q1E extrapolation, annual ongoing commitment), USP <797> (2023 revision — Categories 1/2/3, BUD tables, gloved-fingertip + media-fill, Designated Person), USP <800> (NIOSH hazardous-drug containment, AoR, C-SEC/C-PEC/CSTD, wipe sampling), Environmental monitoring (Annex 1 2022 revision — Grade A <1 CFU, species-level ID, alert vs action, excursion flow), and AQL (ISO 2859-1 / ANSI Z1.4 — code letters, switching rules, OC curves). Added short stubs for the five new entries so they're indexable from the A-Z. ~44 short entries left in the queue.

• newPillar pages for Cleaning validation, Stability programme, USP <797>, USP <800>, Environmental monitoring and AQL — each renders the long-form layout.
• improvedSoftware version — bumped to v5.10.001.551.

Shipped 4,000-word pillar pages for Cp/Cpk (with the Cp-vs-Cpk diagnostic gap and the Western Electric / Nelson rules), PPQ (FDA Stage 2 — protocol content, elevated sampling, three-batch rationale), CPV (FDA Stage 3 — rolling Ppk, OOT signals, APR feed), Tech transfer (ICH Q10 §2.3 + WHO TRS 961 — SU/RU, knowledge package, comparability, regulatory matrix), Gage R&R (AIAG 10×3×3, %GRR/%P/T/NDC, attribute kappa), and MSA (the umbrella: bias, linearity, stability, repeatability, reproducibility). 50 short entries left in the queue.

• newPillar pages for Cp/Cpk, PPQ, CPV, Tech transfer, Gage R&R and MSA — each renders the long-form layout instead of the short card.
• improvedSoftware version — bumped to v5.10.001.550.