# Ketryx for Pharma & Biotech

## One validated platform, total compliance.

From validating the computerized systems that support IND-enabling studies through to commercial release and post-market surveillance, Ketryx automates GxP validation evidence, traceability, and audit readiness so your teams spend less time on documentation and more time on science.

30 minutes · No commitment · Tailored to your regulatory requirements

## The Reality

### Traditional compliance is a bottleneck.

Audit readiness treated as an event, not a continuous state.

Without continuous compliance monitoring, teams scramble to reconstruct evidence packages before inspections. Early-stage biotech companies and CDMOs face the same regulatory scrutiny as large pharma, with a fraction of the resources.

Data integrity gaps across systems, sites, and vendors.

ALCOA+ obligations are difficult to enforce consistently when audit trails are disconnected, electronic signature workflows are inconsistent, and record-keeping is manual. Non-compliance remains one of the most common causes of FDA warning letters and EMA inspection findings.

Fragmented toolchains and manual CSV processes.

Spreadsheets, Word documents, and shared drives create brittle, audit-vulnerable records. Traditional computerized system validation is slow, expensive, and increasingly misaligned with FDA's risk-based CSA framework. Teams spanning GLP, GMP, and GCP environments have no unified compliance view.

## How Ketryx Works

### One platform that connects regulatory compliance to development.

#### Aligned with CSA and GAMP 5

Ketryx replaces static validation documents with living, auto-generated records. Requirements, risks, test protocols, and results are captured, traced, and versioned automatically, supporting URS, FS, DS, IQ, OQ, and PQ documentation aligned with FDA CSA (February 2026) and GAMP 5 2nd Edition, with structured validation evidence always ready to support BLA and NDA submission preparation.

#### ALCOA+ enforced at every touchpoint

Ketryx enforces ALCOA+ at every touchpoint, automatically attributing, timestamping, and immutably storing every change, approval, and test result across GLP, GMP, and GCP systems. Electronic signatures support 21 CFR Part 11 and Annex 11 with multi-factor authentication, full versioning, and a complete, defensible audit trail.

#### Connected workflows so nothing falls through the cracks

Ketryx connects change control and CAPA workflows natively, automatically linking Change Requests to affected systems, validation records, risks, and test cases. CAPA traces from root cause to effectiveness check, with instant notification to responsible owners when follow-up validation activity is required.

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#### Supplier qualification, SBOMs, and vulnerability management

Pharma and biotech organizations depend on complex vendor, cloud, and third-party software ecosystems. Ketryx manages supplier qualification, vendor testing evidence, SBOM generation, and software inventory in one place. Vulnerability scanning runs continuously against GHSA, with NVD available on request, and supplier records link directly to your system inventory. Forward compatible with EU GMP Annex 22 AI system requirements, subject to final regulatory guidance.

## Results

### Trusted by 4 of the Top 5 Life Science Leaders

0%
Reduction in manual trace matrix maintenance

0%
Audit-ready, 100% of the time

0x
Faster documentation cycles

Hours
Time-to-value, not months

### Integrations

#### Connects to the tools your team already uses.

Ketryx overlays your existing development and compliance tools — no rip-and-replace required. Your engineers stay in the tools they already use.

### How Aignostics is Accelerating AI Development in Pathology with Ketryx

Aignostics is a global artificial intelligence (AI) company that turns complex multi-modal pathology data into transformative insights. With an expanding portfolio of AI-powered pathology products, Aignostics needed a streamlined, integrated solution to support their regulated software development processes and ISO 13485 certification. By transitioning to Ketryx, Aignostics was able to cut their release time down to three months while staying compliant.

**Compliance Breadth**

## Built for the Frameworks That Govern Your Work

| Standard or Filing | What It Requires | How Ketryx Helps |
| --- | --- | --- |
| **FDA 21 CFR Part 11** | Electronic records and electronic signatures, audit trails, access controls, and tamper-evident record integrity for GxP electronic systems | Complete audit trails across all connected tools, role-based access enforcement, and electronic signature workflows |
| **FDA CSA Guidance** | Risk-based Computer Software Assurance with validation effort proportional to software risk, leveraging automated testing and objective evidence | Risk-based validation workflows, automated evidence generation, and continuous validation records aligned with CSA's outcome-focused model |
| **EU GMP Annex 11** | Computerized systems in GMP environments including data integrity, audit trails, electronic signatures, and supplier qualification | Validation lifecycle management, system-wide audit trails, change control, and supplier qualification evidence |
| **EU GMP Annex 22** | Forthcoming — AI and machine learning systems in GMP manufacturing including risk classification, monitoring, and validation of AI-generated decisions | Traceability and risk documentation for AI-assisted decisions — subject to final guidance |
| **GAMP 5, 2nd Edition** | GxP software validation methodology using a risk-based approach across software categories | IQ/OQ/PQ protocol support, V-model traceability, and risk category-based validation scoping |
| **ICH Q9** | Quality Risk Management: risk-based approach to pharmaceutical quality decisions from change control to deviation management | Risk-based workflows for change control, CAPA, deviation management, and validation scoping |
| **ICH Q10** | Pharmaceutical Quality System: integrated quality management, CAPA, change control, and management review across the product lifecycle | PQS lifecycle management, CAPA workflows, change control, and quality KPI tracking |
| **FDA Data Integrity Guidance** | ALCOA+ requirements for all FDA-regulated electronic and paper records | Attributed records, immutable audit trails, contemporaneous capture, and electronic signatures |
| **EMA Data Integrity Guidance** | EU data integrity expectations for GMP records, consistent with FDA ALCOA+ framework | Same underlying capabilities as FDA data integrity support, applied to EU GMP record-keeping |
| **PIC/S PE 009** | International GMP guide for computerized systems, aligned with Annex 11 and GAMP 5 | Full support through Annex 11 and GAMP 5 alignment |

## Frequently Asked Questions

### We already have an eQMS. Why do we need Ketryx?

### Does Ketryx support the shift from CSV to CSA?

### Can we adopt Ketryx on a product already in development?

### Is Ketryx validated for use in a regulated environment?

### Does Ketryx support both FDA and EU regulatory submissions?

### How does Ketryx handle third-party software components?

### We already use an ALM. Why do we need Ketryx?

### Does Ketryx support drug-device combination product standards?

# Ketryx for Pharma and Biotech

## Ready to Make Audit Readiness Your Default State?

Every week spent on manual compliance documentation is a week not spent building the drugs that patients need. Ketryx gives that time back.