Pharma / Biotech

cGMP + GCP + Part 11, in one platform

FDA 21 CFR 210 / 211 cGMP, 21 CFR Part 11 e-records, ICH Q7-Q12 quality guidelines, ICH E6 GCP, EU Annex 1 sterile, USP monographs, GAMP 5 CSV, DSCSA serialization, PAT / QbD. Built for pharma, biotech, CDMO, and clinical-site programs.

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8 lifecycle phases

27 auto-seeded gate criteria

18 SysML stencil blocks

18 program templates

Methodology-backed bycGMP / ICHNASA SE HandbookINCOSE SE v5ISO/IEC/IEEE 15288

Methodology

21 CFR 210 · 211 · Part 11 · ICH Q7-Q12 · E6 GCP · Annex 1

Every pharma program runs through the same 8-phase lifecycle — Discovery, Pre-clinical, Clinical, Submission, Approval, Manufacturing, Post-market, Lifecycle. 30+ gate criteria cover 21 CFR 211 cGMP, 21 CFR Part 11 e-records, ICH Q7-Q12 quality guidelines, ICH E6 (R2/R3) GCP, EU Annex 1 sterile, GAMP 5 CSV, DSCSA serialization, and pharmacovigilance per ICH E2A/B/D. Built for pharma, biotech, CDMOs, and clinical-site programs.

Discovery

Discovery & Target ID

Pre-clinical

Pre-clinical & IND Enabling

Clinical

Clinical Trials (Phase I-III)

Submission

Regulatory Submission

Approval

Approval & Launch

Manufacturing

Commercial Manufacturing

Post-market

Post-market Surveillance

Lifecycle

Lifecycle Management

What's Included

Everything programs in your industry actually need

📋

Gates Out-of-the-box

27 readiness criteria auto-seeded on every new program. No blank-page starts.

🧱

Native MBSE Stencils

SysML palette with 18 blocks specific to your domain — drop and go.

🎯

Program-type Templates

18 archetypes pre-configured so you start from the right place.

🤖

AI-assisted, Domain-aware

Our AI advisor knows cGMP / ICH — not generic SE. Prompts, references, and deliverables frame themselves correctly.

Built for

Program archetypes we support

💊

Small Molecule NCE

New chemical entity — small molecule drug

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Biologic / mAb

Monoclonal antibody or biologic program

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Vaccine

Prophylactic or therapeutic vaccine

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Gene / Cell Therapy

AAV / lentiviral / CAR-T / gene-editing therapy

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Sterile Injectable

Aseptic fill-finish (Annex 1 scope)

🧑‍⚕️

Clinical Trial

Phase I / II / III clinical study

Inside the pack

Every tool your program needs, shipping today

Every GMP record, Part 11 audit trail, stability study, and CAPA gets a dedicated page. Full doc-gen (VMP, APR/PQR, PPQ Protocol, Deviation/CAPA, Part 11 Assessment). No more Veeva / TrackWise / MasterControl data prisons.

cGMP & Quality 21 CFR 211 · ICH Q7 · Q9 · Q10 · Q12

The quality system that auditors actually review — not a SOP database.

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cGMP 21 CFR 211 Checklist

Per-subpart evidence tracker for buildings, equipment, processes, materials, packaging, labeling.

21 CFR 211 Subparts B-K

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ICH Q9 Quality Risk Management

QRM toolset — FMEA / FTA / risk-matrix with cross-reference to CQAs and CPPs.

ICH Q9 (R1)

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ICH Q10 Pharma Quality System

PQS components — management responsibility, resource, process performance, continual improvement.

ICH Q10

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EU Annex 1 Sterile

Contamination Control Strategy + QRM + EM program per revised Annex 1 (2022).

EU Annex 1 (2022)

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Annual Product Review

APR / PQR covering batches, trends, stability, deviations, changes, supplier perf, regulatory.

21 CFR 211.180(e) / ICH Q7 Cl. 2.5

Compliance / CSV Part 11 · GAMP 5 · ALCOA+

The electronic-records story — validated systems, ALCOA+ data integrity, Part 11 audit trails.

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21 CFR Part 11 E-Records

Per-system Part 11 assessment with 11.10 / 11.30 / 11.50 / 11.70 / 11.200 / 11.300 compliance.

21 CFR Part 11

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CSV / GAMP 5

Risk-based CSV per GAMP 5 (2nd ed) with category-specific deliverables.

ISPE GAMP 5

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VMP / IQ / OQ / PQ

Validation Master Plan with IQ/OQ/PQ protocol + summary register for each qualified asset.

EU Annex 15 / ICH Q7

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Data Integrity (ALCOA+)

ALCOA+ assessment across systems with audit-trail review cadence and gap-closure.

MHRA / FDA / WHO

Regulatory IND · NDA · BLA · ANDA · eCTD

Submission tracking — from IND through NDA/BLA/MAA with CTD Module 1-5 structure.

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IND / CTD Tracker

IND + CTA submission + amendments + annual reports with hold status tracking.

21 CFR 312 / ICH M4

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NDA / BLA / ANDA

Path declaration (505(b)(1) / 505(b)(2) / ANDA) with Module 1-5 assembly status.

FDA CDER / CBER

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EMA MAA / eCTD

Module 1 EU-specific + centralized / decentralized / MRP procedure tracking.

EMA eCTD

Clinical & PV ICH E6 GCP · ICSR · Aggregate Reports

Clinical operations and pharmacovigilance — GCP-compliant trial + post-market safety.

🧑‍⚕️

Clinical Trial (GCP)

Per-study TMF / protocol / IB / IRB-EC / DSMB + site monitoring log.

ICH E6 (R2/R3)

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Pharmacovigilance

ICSR + SAE logging + aggregate report (PADER / PBRER / DSUR) + signal management.

ICH E2A/B/D

Operations Deviations · CAPA · Change Control · Stability · Batches

The operational GMP lifecycle — every deviation, every batch, every supplier traced.

⚠️

Deviation / CAPA

GMP deviation + CAPA tracker with root-cause + effectiveness-check cycle.

ICH Q10 / 21 CFR 211.192

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Change Control (ICH Q12)

Established conditions + post-approval change management per ICH Q12 + PACMP.

ICH Q12

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Batch Record / eBR

Master + executed batch records with in-process control and release decision log.

21 CFR 211.186 / 211.188

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Stability Study

ICH Q1 A/B/C/D/E stability protocol + pull schedule + results tracking.

ICH Q1A-E

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Supplier Qualification

Approved supplier list with risk tiering + audit schedule + TSE/BSE where applicable.

ICH Q7 Cl. 7

Supply Chain DSCSA · USP · PAT

Serialization, compendial compliance, and process analytical tech.

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DSCSA Serialization

Serialization + EPCIS events + suspect-product investigation + verification.

FDA DSCSA

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USP Monograph

Per-monograph compliance tracker for API + excipients + drug products.

USP/NF / Ph.Eur. / JP

Depth 16 starter requirements · 18 SysML blocks · 5 doc templates

Pack ships deep. Starter requirements cover cGMP, Part 11, CSV, DI, stability, APR, Annex 1, GCP, PV, DSCSA, supplier, Q12, inspection. SysML palette — Drug Product, API, Excipient, CQA, CPP, Mfg Step, Clinical Study, Site, Suite, Cleanroom, Equipment, Computerized System, Batch Record, Stability, Supplier, Deviation. Doc-gen for VMP, APR, Deviation/CAPA, PPQ, Part 11 Assessment.

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Starter Requirements

16 starter requirements across cGMP, Part 11, CSV, DI, stability, APR, Annex 1, GCP, PV, DSCSA, supplier, Q12, inspection.

FDA / ICH / EMA

🧱

Pharma SysML Palette

18 pre-configured blocks for drug product, API, excipients, mfg steps, CQAs/CPPs, clinical studies, GMP suites, computerized systems, deviations.

OMG SysML

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Doc-gen Templates

Validation Master Plan · Annual Product Review · Deviation/CAPA · PPQ Protocol · Part 11 Assessment — real content, not stubs.

Regulatory boilerplate

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Program Archetypes

18 templates — Small Mol NCE, mAb, Biosimilar, Vaccine, Gene/Cell Therapy, mRNA, ANDA, OTC, Combination Product, API, Sterile Injectable, Solid Dose, Clinical Trial, CDMO, DSCSA, APR, Site Transfer.

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✔30-day pilot. No credit card required.

✔Your data in, your data out. Standard formats only.

✔Self-hosted option for classified programs.

Your first industry pack is free.

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