Real Workflows Across Every Pack
End-to-end workflows across 20 industry packs — aerospace CDR, defense MS B, 510(k) + DHF, grid COD, banking SR 11-7 validation, automotive ASIL release, FedRAMP authorization, FSMA recall, pharma APR/PQR, offshore SEMS, and more.
LEO Earth Observation CDR Review Package
The Challenge
CDR is six weeks out. The PM needs full requirements traceability from mission objectives through subsystem specs, current mass / power / ΔV margins, risk status, and phase-gate readiness. Today this means pulling data from four tools, cross-referencing spreadsheets, and assembling a deck that takes two engineers two weeks to build.
The Workflow
The Aerospace Pack auto-seeds SMAD’s 8-phase lifecycle, 104 gate criteria, and 50+ spacecraft calculators. Requirements, risks, and budgets link into the SMAD phase structure from day one.
Connect requirements to the mass, power, link, and ΔV budgets. Associate risks with affected requirements. The RTM builds itself as you work.
CDR readiness items are pre-seeded from the aerospace pack. Mark each Red, Yellow, Green or N/A. See the gate readiness percentage at a glance.
One-click PDF export of the CDR package — requirements trace, budget margins, risk summary, gate readiness. The deliverable your review board expects, assembled in minutes.
The Outcome
A complete CDR review package that used to take two weeks, delivered in an afternoon. Requirements fully traced, margins current, risks linked to gate items.
Tactical UAS Milestone B Readiness Review
The Challenge
MS B is 90 days out. The program needs a validated CDD, approved Acquisition Strategy, completed TRA, CMMC Level 2 posture in place, and DoDAF architecture views baselined. Today this means juggling DOORS for requirements, Cameo for DoDAF, spreadsheets for CMMC, and SharePoint for CDRLs.
The Workflow
Auto-seeds DoD 5000.02 milestones (MDD → FOC), 58 gate criteria, DoDAF stencils, CMMC tracker, and the CDRL / SDRL manager. Terminology switches to Program / Milestone Review.
Draft OV-1, OV-2, OV-5a, SV-1, SV-4 in the integrated viewpoint browser. Link views to requirements and risks. 52 views tracked against baselining status.
Walk the 37 CMMC Level 1/2 practices. Attach evidence (policies, procedures, test records). Each "Open →" button in the tracker opens the matching document in the register.
One-click export of the MS B readiness package — CDD, Acquisition Strategy, TRA, CMMC posture, DoDAF baseline, open CDRLs. CDRL-formatted PDFs the way the reviewer expects.
The Outcome
MS B entry approval on the first board presentation. No scramble for evidence on audit day, no last-minute CDRL assembly.
Class II Infusion Pump 510(k) + DHF Compilation
The Challenge
Submitting a 510(k) for a Class II infusion pump with Class B embedded software. The team needs a compiled DHF (21 CFR 820.30), an ISO 14971 risk file with residual-risk evidence, a SOUP register with CVE status, predicate analysis with substantial-equivalence justification, and complete V&V evidence. Today the pieces live across Jama, a RiskFile spreadsheet, a NetBoard SBOM, and a Notion page.
The Workflow
IEC 62304 lifecycle (Planning → PMS) seeds with 53 gate criteria. Terminology switches to Device / Design Review. Hazard analysis, DHF builder, SOUP register, and 510(k) predicate search are wired together.
Capture hazards with severity × probability on the 5×5 residual-risk matrix. Each hazard can promote to a mission risk with one click. Missing risk-control items show up as open gate criteria.
Walk the 20 DHF sections (design inputs / outputs / reviews / V&V / transfer). Attach evidence links. SOUP items flagged by CVE status and safety class. "Open →" buttons jump to linked documents.
One-click export of the DHF package, risk management file, SOUP register, and predicate analysis memo — each as a formatted PDF ready for FDA submission.
The Outcome
A 510(k) submission package assembled inline with the engineering work, not as a three-month pre-submission scramble.
50 MW Solar + BESS Interconnect to COD
The Challenge
A 50 MW AC solar PV site co-located with a 25 MW / 100 MWh BESS needs to move from LGIA execution through commissioning to COD. The team needs to track the SIS, FIS, LGIA milestones; IEEE 1547-2018 conformance evidence; NERC CIP-003 through CIP-013 posture for BES cyber assets; and FAT / SAT / point-to-point commissioning results. Today this lives in PowerWorld exports, SEL relay config spreadsheets, and contractor PDFs.
The Workflow
NERC / IEEE 1547 lifecycle seeds with 45 gate criteria across Concept → Interconnect → Design → Build → Commissioning → Operations. Grid interconnect workflow, reliability roll-up, and NERC CIP tracker pre-wired.
Track each of the 11 interconnect milestones (Application → LGIA → COD). Each milestone surfaces action chips into Phase Gate / Documents / Risks / Verification, plus an inline + Doc button that creates a documents-register entry.
Walk NERC CIP-003 → CIP-013 with an impact-tier filter (High / Medium / Low). Attach policy / procedure / test-record references to each requirement. Export the evidence bundle for the regional audit.
The substation commissioning tracker walks FAT → SAT → P2P → Protection Functional → Integrated System tests with phase-filter chips and pass/fail/retest status. One-click + Doc generates the commissioning report.
Generate the COD authorization package — LGIA, SIS/FIS, IEEE 1547 test reports, NERC CIP evidence, commissioning records — each as a formatted PDF in the document register.
The Outcome
COD declared on schedule with the utility’s witness-test evidence already assembled. NERC CIP posture stays audit-ready through operations, not a quarterly scramble.
SR 11-7 Annual Model Validation + Board Reporting
The Challenge
The annual SR 11-7 validation cycle is starting. 40 tier-1/2 models need independent validation, DORA TLPT results need to feed board reporting, and SOX ITGC controls for the model platform need to be tested. Today: validation memos live in Word, model inventory in Excel, DORA results in a PDF scan, board packs in PowerPoint.
The Workflow
27 gate criteria across SR 11-7, DORA, Basel, SOX, BSA/AML, FFIEC. Model inventory, validation workflow, ICT resilience, SOX ITGC, and exam-prep tools pre-wired.
Per-model validation memo template: conceptual soundness + outcomes analysis + process verification + ongoing monitoring. Tier, materiality, and findings roll up.
TLPT scenario coverage + ICT incident register + third-party dependency map. Each finding links to remediation + residual risk.
One-click export: model inventory, validation status by tier, DORA resilience posture, SOX deficiencies, AML KYC metrics. Formatted for the Audit Committee.
The Outcome
Board meeting presented on schedule with a complete, audit-defensible package. Validation evidence stays live for the next exam, not reassembled from scratch.
ASIL-D Brake Controller Release with ISO 21434 Cybersecurity Case
The Challenge
Releasing an ASIL-D electric brake booster for SOP. ISO 26262 safety case needs to close with HARA + ASIL decomposition + safety case argument. ISO/SAE 21434 cybersecurity case needs TARA + verification. ASPICE SWE.1-5 assessment is 60 days out. R155 CSMS certificate must stay valid.
The Workflow
28 gate criteria + ASIL decomposition + HARA + TARA + SOTIF + ASPICE + R155/156 + ALKS R157 + IATF 16949 tools ready.
GSN argument structure with evidence links. HARA hazards map to safety goals → functional safety requirements → hardware/software requirements → verification. Each node open to open findings.
TARA attack paths + threat model with countermeasures. Cyber verification evidence (pen test, fuzz, supply-chain SBOM) rolls up against R155 CSMS clauses.
One-click SOP readiness package: safety case, cyber case, ASPICE assessment evidence, APQP/PPAP Part Submission Warrant. Ready for the OEM gate.
The Outcome
SOP released on time with no re-work loops. Tier-1 passed OEM gate on first review with complete safety + cyber traceability.
CBTC Signalling SIL-4 Safety Case Acceptance
The Challenge
A metro CBTC upgrade needs the Generic Application Safety Case (GASC) + Specific Application Safety Case (SASC) accepted by the Designated Body before revenue service. EN 50128 SIL-4 software evidence, EN 50129 cross-acceptance arguments, and independent safety assessor (ISA) actions all need closure.
The Workflow
EN 50126 RAMS + EN 50128 SIL 0-4 + EN 50129 safety case + ERTMS + PTC + FRA 49 CFR tools. 26 gate criteria.
Nested safety case: generic product argument → generic application → specific application. ISA findings tracked with evidence and resolution status.
EN 50128 techniques-and-measures table filled with evidence per SIL. SCADE / MISRA / coverage reports attached per module.
One-click: GASC + SASC + ISA memo + verification evidence + cross-acceptance arguments. Formatted for the Designated Body.
The Outcome
Safety case accepted without follow-up actions. Revenue-service date held.
SMR Construction Permit (10 CFR 50) Application Assembly
The Challenge
An SMR design-certification applicant is filing for a Construction Permit. Chapters 1-19 of the PSAR need to close with NQA-1 QA program evidence, PRA Level 1+2 results, IEEE 603 Class 1E evidence, and ASME Section III design reports — all tied to 10 CFR 50 General Design Criteria.
The Workflow
28 gate criteria + PSAR chapter tracker + NQA-1 QA program + PRA + IEEE 603 + ASME III + Reg Guide 1.174 + NEI 08-09 cyber.
Each chapter maps to GDCs + Reg Guides + SRP sections. Open findings, audit notes, and rev-status visible at a glance.
NQA-1 18-criteria table with procedure + audit + NCR trace. IEEE 603 safety system requirements linked to V&V records.
One-click export of the PSAR + QA program + PRA summary + environmental report + ITAACs. Indexed as the NRC expects.
The Outcome
CP application accepted for docketing on first submission. No RAI cycle on missing evidence.
ANDA Annual Product Review (APR) + ICH Q1 Stability
The Challenge
An oral solid-dose ANDA product APR is due in 45 days. Batch record review across 40 commercial batches, deviation + change-control review, APR trend analysis, ICH Q1 stability data-pull, complaint trending, and CAPA effectiveness — today this lives across LIMS exports, deviation Word memos, stability Excel workbooks, and a vendor quality portal.
The Workflow
30 gate criteria + 21 CFR 211 cGMP + ICH Q7-Q12 + Part 11 + GCP + Annex 1 + ICH Q1 stability + FDA submission tools.
Batch genealogy + yield trend + deviation + change-control + OOS/OOT + complaints + CAPAs — all linked to the product in one place.
Time-point stability data across lots (long-term + accelerated + intermediate) with trend + shelf-life projection.
One-click APR narrative with trend graphs + deviation summary + change-control summary + CAPA effectiveness + stability conclusions. ANDA-ready format.
The Outcome
APR filed on time without the Friday-night assembly grind. Trend signals flagged live, not at year-end.
Refinery Turnaround + API 510 Pressure-Vessel Inspection
The Challenge
A 5-year refinery turnaround ahead. 200 pressure vessels on the API 510 inspection schedule, 300 piping circuits on API 570, PSM 14-element PHA refresh, IEC 61511 SIS proof tests, and EPA RMP Program 3 re-evaluation — all need to close during the outage window.
The Workflow
26 gate criteria + API 510/570/653 + IEC 61511 SIS + OSHA PSM + EPA RMP + API 754 + BSEE SEMS tools.
Per-vessel and per-circuit inspection due-date, last-RT/UT, corrosion-rate, T-min, fitness-for-service. Risk-based inspection tiering visible.
HAZOP / LOPA nodes with open scenarios, IPLs, and SIL target vs. verified. Each gap rolls into the turnaround punch list.
One-click: inspection records + PHA memo + SIF proof-test results + RMP update + API 754 Tier 1-4 metrics. Ready for the next PSM audit.
The Outcome
Turnaround closed on schedule with zero PSM audit findings at the next compliance review.
Newbuild LNG Carrier Delivery + EEXI / CII Compliance
The Challenge
A newbuild 174K-cbm LNG carrier approaches delivery. IMO + class society (DNV / ABS / LR) surveys, ISM + ISPS code certification, BWMS commissioning, EEXI + CII attained-vs-required, and MLC 2006 seafarer compliance — all need to close before flag acceptance.
The Workflow
26 gate criteria + IMO SOLAS/MARPOL + ISM/ISPS + IACS URs + USCG + BWMS + EEXI/CII + MLC tools.
Per-survey item (hull, machinery, load line, safety equipment) with status, finding, and clearance date. Flag-state-specific additions tracked.
Energy Efficiency Existing Ship Index + Carbon Intensity Indicator calculation with vessel particulars and annual voyage data. Required-vs-attained delta + rating.
One-click: class certificate bundle + flag compliance + EEXI/CII report + ISM/ISPS certificates + crew STCW + MLC evidence. Ready for vessel acceptance.
The Outcome
Vessel delivered on schedule with clean certificates and CII rating A. No delayed acceptance at first port.
LCRR Lead Service Line Inventory + AWIA §2013 RRA
The Challenge
A mid-size utility must submit the LCRR lead service line initial inventory to the state + EPA, refresh the AWIA §2013 Risk & Resilience Assessment, update the Emergency Response Plan, and close CWA NPDES pretreatment findings from the last state inspection.
The Workflow
24 gate criteria + LCRR LSL inventory + AWIA RRA/ERP + CWA NPDES + AWWA G-series + CUPSS + Ten States Standards.
Per-service-line classification (lead / galvanized / non-lead / unknown) with evidence method + replacement priority. Connection-count rollup + map.
Vulnerability assessment across cyber, physical, natural-hazard, and intentional threats. ERP updated + certified. Findings link to capital-plan budgets.
Per-IU inspection cycle + sampling results + violation log + SNC determination. Each NOV links to a corrective action.
One-click: LCRR inventory + AWIA RRA certification + ERP + NPDES annual report. Formatted per EPA / state template.
The Outcome
LCRR deadline met. No NOV at next sanitary survey. ERP accepted by state DHS on first review.
5G NR Small-Cell Rollout + FCC Part 25/27 + NENA 911
The Challenge
A CBRS + C-band small-cell densification across a metro. FCC Part 27 licensing + Part 25 backhaul satellite coordination + CBRS SAS/CPI + 3GPP 5G NR parameter-set testing + O-RAN fronthaul + NENA i3 911 routing — today each lives in a different tool.
The Workflow
24 gate criteria + FCC Part 15-90 + 3GPP 5G/6G + O-RAN + NENA + ITU-R + CBRS SAS/CPI + antenna PIM + backhaul tools.
Per-site license / STA + CBRS SAS grant + PAL/GAA allocation + CPI certification. Site inventory rolls up.
Per-gNB throughput/latency KPI tests against 3GPP NR spec. O-RAN OFH C/U/M-plane conformance logs.
Per-site routing table + ESRP cutover + NENA i3 conformance test + PSAP acknowledgment.
One-click: FCC license bundle + CBRS grant list + 3GPP test reports + O-RAN conformance + NENA i3 evidence. Ready for regulator + customer.
The Outcome
Phase 1 rollout launched on schedule. Regulator audit clean. Customer SLA met from day one.
Hospital Addition TCO + LEED v4.1 Gold Certification
The Challenge
A 200-bed hospital addition targeting LEED v4.1 Gold + WELL Silver + TCO under local AHJ. IBC occupancy compliance, ACI 318 concrete + AISC 360 steel submittals, NFPA 13/25/70 fire + life safety, ASCE 7 seismic, ADA accessibility, and OSHA 1926 safety observations — all during a 90-day closeout.
The Workflow
26 gate criteria + OSHA 1926 + IBC/IFC/IRC + ACI 318 + AISC 360 + NFPA 13/25/70 + ASCE 7 + LEED v4.1 + ADA tools.
Per-submittal (concrete, steel, fire-sprinkler, electrical) with review + SI / RFI tie + AHJ approval status.
Per-door, per-fixture, per-route accessibility compliance with evidence + corrective cycle.
Per-credit submittal status + evidence + points awarded. Pre-certification review + GBCI audit-ready.
One-click: submittal close-out + LEED scorecard + OSHA log + final AHJ walk results. Ready for hospital occupancy.
The Outcome
TCO issued on schedule. LEED Gold certified, WELL Silver on track. Zero OSHA recordables during closeout.
Specialty Chemical TSCA PMN + OSHA PSM Launch
The Challenge
A new specialty monomer launches in 180 days. TSCA PMN (90-day review) + EU REACH registration + OSHA PSM 14-element program + EPA RMP Program 3 (threshold exceeded) + CCPS RBPS baseline + IEC 61511 SIF verification + GHS SDS — all on the critical path.
The Workflow
26 gate criteria + TSCA/REACH + PSM 14-element + RMP + CCPS RBPS + IEC 61511 + GHS HazCom tools.
PMN Section A-G + technical data + SNUR evaluation + EPA 90-day clock. REACH dossier + SVHC check parallel.
Process safety information + HAZOP + LOPA + SIS + operating procedures + training + mechanical integrity + MOC + incident investigation + emergency response. RMP Program 3 hazard + offsite consequence.
IEC 61511 per-SIF PFDavg + proof-test. GHS label + SDS per region + language.
One-click: PMN receipt + REACH registration number + PSM program binder + RMP submission + SIS report + SDS pack. Ready for start-up readiness review.
The Outcome
On-schedule launch with clean PMN / REACH + PSM audit pass at month 6.
AEC-Q100 Automotive IC Tapeout + JEDEC Qualification
The Challenge
A 28nm automotive MCU tapeout targets ASIL-B supplier. JEDEC JESD22 reliability qual + AEC-Q100 stress tests + ISO 14644 Class 5 cleanroom compliance + ANSI/ESD S20.20 HBM/CDM + SEMI S2/S8 equipment safety + CHIPS Act export controls — all gating PPAP.
The Workflow
26 gate criteria + SEMI S2/S8/S14 + JEDEC JESD22/JESD47 + ISO 14644 + ANSI ESD S20.20 + AEC-Q100/200 + CHIPS + IPC tools.
Per-test (HTOL, THB, TC, PC, AC, ESD, EMC) sample size + readpoint + failure count + FA. Rolls up per-grade qual report.
ISO 14644 particle count + airflow + pressure differential + ESD audit + HBM/CDM test bench.
Per-customer + per-end-use + license determination (EAR / ITAR / BIS) with signed end-use statement.
One-click: JEDEC qual report + AEC-Q100 qual + ISO 14644 cert + ESD audit + CHIPS export list + IATF 16949 APQP. OEM submits in one bundle.
The Outcome
First-pass PPAP acceptance at Tier-1. SOP on schedule. No follow-up data requests.
P&C Carrier ORSA + IFRS 17 Transition + SERFF Filing
The Challenge
A multi-state P&C carrier: annual ORSA report to domiciliary regulator + IFRS 17 opening balance sheet + Q1 homeowners rate filing through SERFF (all 50 states) + NAIC RBC update + MCAS filing — all in Q1.
The Workflow
26 gate criteria + NAIC RBC + ORSA + Solvency II SCR + IFRS 17 + ASOP + MCAS + SERFF + NAIC IDSLMA.
Per-risk category (credit, market, insurance, operational, liquidity, strategic, emerging, climate) inherent + residual + appetite. Capital-vs-appetite analysis + stress scenarios.
Per-contract-group measurement model (GMM / VFA / PAA) + CSM + LRC + LIC + onerous test. GAAP-to-IFRS 17 walk.
Per-state rate + form + rule filing with actuarial justification. Status and filing fees tracked.
One-click: ORSA summary + RBC report + IFRS 17 transition memo + MCAS + SERFF receipts. Domiciliary + FIFTY-state ready.
The Outcome
ORSA accepted without follow-up RFIs. IFRS 17 transition certified clean. Q1 rate filings approved in 42 of 50 states.
Coal Mine SMCRA Permit Renewal + GISTM TSF + MSHA Audit Prep
The Challenge
A surface coal mine: 5-year SMCRA permit renewal through OSMRE + state regulator, GISTM TSF annual conformance review, MSHA Part 77 + Part 70 audit prep, NPDES outfall monitoring, and blasting + fugitive-dust controls — all on overlapping timelines.
The Workflow
27 gate criteria + MSHA Parts 46/48/56/57/70/75/77 + SMCRA/OSMRE + GISTM + NPDES + CAA NESHAPs + blasting + ICMM tools.
Per-section (exploration, operations, processing, reclamation, water, air, wildlife) current + revision status + bond adjustment.
Engineer of Record + Responsible Tailings Facility Engineer + Design Basis Report + dam breach analysis. Annual review closeout.
Part 46/48 training currency + Part 70 respirable dust + Part 77 impoundment 77.216 + Part 75/77 electrical + ground control. Citation history + POV risk.
One-click: SMCRA permit renewal + GISTM TSF dossier + MSHA Part 77 folder + NPDES annual + ICMM sustainability. Ready for each regulator.
The Outcome
SMCRA renewal approved without RFI. GISTM conformance certified. MSHA audit: zero S&S citations.
FSMA Sec 204 Traceability Go-Live + Mock Recall Drill
The Challenge
A leafy-greens processor: FSMA Sec 204 (Jan 2026) go-live for FTL commodities with CTE + KDE capture, FSVP re-approval for 40 foreign suppliers, SQF audit prep, annual mock recall, and PCHF food safety plan reanalysis — all in one quarter.
The Workflow
27 gate criteria + FSMA PCHF + Produce + FSVP + Sec 204 + HACCP + cGMP + USDA FSIS/Organic + FIFRA + GFSI tools.
Per-commodity on the Food Traceability List: TLC assignment + CTE (harvest, cooling, pack, first receiver, transformation, ship, receive) + KDE capture + 24-hr FDA response capability.
Per-foreign-supplier: hazard analysis + evaluation + verification activity (audit, sample, records) + frequency. Overdue suppliers flagged.
End-to-end recall simulation from first consumer call → FDA 24-hr notification → effectiveness check % → units recalled. Drill closeout memo + lessons learned.
One-click: Sec 204 go-live readiness + FSVP dossier + PCHF reanalysis + SQF evidence + mock recall report. Ready for the next audit.
The Outcome
Sec 204 go-live on schedule. Mock recall closed in 2 hours vs. target 4. SQF audit scored Excellent.
FedRAMP Moderate JAB P-ATO + CMMC L2 + Annual ConMon
The Challenge
A SaaS CSP chasing FedRAMP Moderate JAB P-ATO: SSP + SAP + SAR + POA&M, 3PAO pen test, continuous monitoring monthly cadence, parallel CMMC L2 C3PAO certification for DoD contracts, Privacy Act PIA + Section 508 VPAT, and CISA BOD 22-01 KEV patching.
The Workflow
29 gate criteria + FedRAMP package + FISMA RMF + NIST 800-53r5 + 800-171 + 800-172 + CMMC L1/2/3 + FAR/DFARS + CISA BOD + Privacy + 508 + StateRAMP + CJIS + IRS 1075 tools.
Per-control (AC / AT / AU … SR family) implementation + responsible role + inheritance + evidence. SSP builds automatically. POA&M tracks finding → remediation SLA.
3PAO SAP → assessment fieldwork → SAR findings → POA&M. Each finding severity → SLA (Critical 30d / High 30d / Moderate 90d / Low 180d).
CMMC L2 110-practice self-assessment → C3PAO review. PIA + SORN published. VPAT + WCAG 2.1 AA remediated.
Per-month: OS/DB/Web vuln scan + POA&M update + significant-change requests + CISA KEV status. Continuous-monitoring monthly report generated.
One-click: SSP + SAR + POA&M + ConMon + CMMC L2 assessment + PIA + VPAT + CISA BOD evidence. Ready for the JAB review board.
The Outcome
JAB P-ATO granted on first review. CMMC L2 certified. Monthly ConMon cadence live without heroics.
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