AI-native orchestration software for pharma manufacturers
Human-in-the-loop AI agents to generate documents, review documents for GMP compliance, and investigate deviations
AI-native orchestration software for pharma manufacturers
Human-in-the-loop AI agents to generate documents, review documents for GMP compliance, and investigate deviations
AI-native orchestration software for pharma manufacturers
Human-in-the-loop AI agents to generate documents, review documents for GMP compliance, and investigate deviations
AI-native orchestration software for pharma manufacturers
Human-in-the-loop AI agents to generate documents, review documents for GMP compliance, and investigate deviations
Developed by experts from
Developed by experts from
Developed by experts from
Developed by experts from
Technology
Introducing Cytara GxP Reviewer
Designed to work within your systems
Cytara runs in the system tray and can be activated with a single key press. It can view your screen and identify what you are working on
Auto-reviews documents for GxP compliance
Cytara fetches relevant, supporting documents from QMS, EDMS, and ERP systems to perform context-aware document reviews in <1 min
Generates traceable review annotations
Annotates the document like a real reviewer while providing comment explanations with verifiable sources and suggesting corrections where appropriate
Works for all GxP documents
Review Assistant supports end-to-end GxP documentation review—from batch records and SOPs to deviations, CAPAs, validations, and regulatory submissions
Technology
Introducing Cytara GxP Reviewer
Designed to work within your systems
Cytara runs in the system tray and can be activated with a single key press. It can view your screen and identify what you are working on
Auto-reviews documents for GxP compliance
Cytara fetches relevant, supporting documents from QMS, EDMS, and ERP systems to perform context-aware document reviews in <1 min
Generates traceable review annotations
Annotates the document like a real reviewer while providing comment explanations with verifiable sources and suggesting corrections where appropriate
Works for all GxP documents
Review Assistant supports end-to-end GxP documentation review—from batch records and SOPs to deviations, CAPAs, validations, and regulatory submissions
Technology
Introducing Cytara GxP Reviewer
Designed to work within your systems
Cytara runs in the system tray and can be activated with a single key press. It can view your screen and identify what you are working on
Auto-reviews documents for GxP compliance
Cytara fetches relevant, supporting documents from QMS, EDMS, and ERP systems to perform context-aware document reviews in <1 min
Generates traceable review annotations
Annotates the document like a real reviewer while providing comment explanations with verifiable sources and suggesting corrections where appropriate
Works for all GxP documents
Review Assistant supports end-to-end GxP documentation review—from batch records and SOPs to deviations, CAPAs, validations, and regulatory submissions
Technology
Introducing Cytara GxP Reviewer
Designed to work within your systems
Cytara runs in the system tray and can be activated with a single key press. It can view your screen and identify what you are working on
Auto-reviews documents for GxP compliance
Cytara fetches relevant, supporting documents from QMS, EDMS, and ERP systems to perform context-aware document reviews in <1 min
Generates traceable review annotations
Annotates the document like a real reviewer while providing comment explanations with verifiable sources and suggesting corrections where appropriate
Works for all GxP documents
Review Assistant supports end-to-end GxP documentation review—from batch records and SOPs to deviations, CAPAs, validations, and regulatory submissions
Drive impact
Reduce Review Cycle Times by 75%
Cytara automates cross-referencing against internal procedures, identifying errors, and documenting findings, minimizing the tedious work that consumes the majority of your reviewers’ time today.
Accelerate Time to Market
When reviews take hours instead of days, everything downstream moves faster - lab results, batch release, tech transfers, change implementations, regulatory submissions, and product launches.
Avoid Costly Compliance Mistakes
Move beyond human-only review. Cytara adds a high accuracy AI safeguard alongside your reviewers, strengthening GxP oversight and dramatically reducing the risk of costly compliance gaps.
Drive impact
Reduce Review Cycle Times by 75%
Cytara automates cross-referencing against internal procedures, identifying errors, and documenting findings, minimizing the tedious work that consumes the majority of your reviewers’ time today.
Accelerate Time to Market
When reviews take hours instead of days, everything downstream moves faster - lab results, batch release, tech transfers, change implementations, regulatory submissions, and product launches.
Avoid Costly Compliance Mistakes
Move beyond human-only review. Cytara adds a high accuracy AI safeguard alongside your reviewers, strengthening GxP oversight and dramatically reducing the risk of costly compliance gaps.
Drive impact
Reduce Review Cycle Times by 75%
Cytara automates cross-referencing against internal procedures, identifying errors, and documenting findings, minimizing the tedious work that consumes the majority of your reviewers’ time today.
Accelerate Time to Market
When reviews take hours instead of days, everything downstream moves faster - lab results, batch release, tech transfers, change implementations, regulatory submissions, and product launches.
Avoid Costly Compliance Mistakes
Move beyond human-only review. Cytara adds a high accuracy AI safeguard alongside your reviewers, strengthening GxP oversight and dramatically reducing the risk of costly compliance gaps.
Drive impact
Reduce Review Cycle Times by 75%
Cytara automates cross-referencing against internal procedures, identifying errors, and documenting findings, minimizing the tedious work that consumes the majority of your reviewers’ time today.
Accelerate Time to Market
When reviews take hours instead of days, everything downstream moves faster - lab results, batch release, tech transfers, change implementations, regulatory submissions, and product launches.
Avoid Costly Compliance Mistakes
Move beyond human-only review. Cytara adds a high accuracy AI safeguard alongside your reviewers, strengthening GxP oversight and dramatically reducing the risk of costly compliance gaps.
How We Work With You
Diagnose
We start by understanding your manufacturing needs, then map what we can deploy turnkey from our existing platform and what needs to be purpose-built for your operation.
Integrate
Your systems stay at the center. We plug directly into your DMS or QMS, with pre-built connectors for Veeva, OpenText, and L7, and the flexibility to meet your stack where it is.
Configure
We tailor everything to your site: your systems, your templates, and your internal procedures, so the AI understands your operating context from day one.
How We Work With You
Diagnose
We start by understanding your manufacturing needs, then map what we can deploy turnkey from our existing platform and what needs to be purpose-built for your operation.
Integrate
Your systems stay at the center. We plug directly into your DMS or QMS, with pre-built connectors for Veeva, OpenText, and L7, and the flexibility to meet your stack where it is.
Configure
We tailor everything to your site: your systems, your templates, and your internal procedures, so the AI understands your operating context from day one.
How We Work With You
Diagnose
We start by understanding your manufacturing needs, then map what we can deploy turnkey from our existing platform and what needs to be purpose-built for your operation.
Integrate
Your systems stay at the center. We plug directly into your DMS or QMS, with pre-built connectors for Veeva, OpenText, and L7, and the flexibility to meet your stack where it is.
Configure
We tailor everything to your site: your systems, your templates, and your internal procedures, so the AI understands your operating context from day one.
How We Work With You
Diagnose
We start by understanding your manufacturing needs, then map what we can deploy turnkey from our existing platform and what needs to be purpose-built for your operation.
Integrate
Your systems stay at the center. We plug directly into your DMS or QMS, with pre-built connectors for Veeva, OpenText, and L7, and the flexibility to meet your stack where it is.
Configure
We tailor everything to your site: your systems, your templates, and your internal procedures, so the AI understands your operating context from day one.
Privacy and Security built in
Zero Data Retention
Cytara does not train on customer data and enforces Zero Data Retention (ZDR). Disaster recovery controls ensure availability during outages, while enforced data retention limits govern archival and secure deletion.
Enterprise Grade Security
Cytara comes with SAML 2.0 SSO and MFA, integrating with existing enterprise identity and access management systems. Customer data is tenant-isolated and third-party integrations use purpose-scoped service accounts.
Data Stays on Device
The Cytara Review Assistant runs on corporate-secured devices. We apply least-privilege and data minimization principles, transmitting only the minimum required data off-device.
Encrypted in Transit and at Rest
All tool interactions are encrypted in transit (TLS) and at rest (AES-256). No one, including Cytara, has read or write access to your internal data. All access is logged and can be audited by your IT team.
Privacy and Security built in
Zero Data Retention
Cytara does not train on customer data and enforces Zero Data Retention (ZDR). Disaster recovery controls ensure availability during outages, while enforced data retention limits govern archival and secure deletion.
Enterprise Grade Security
Cytara comes with SAML 2.0 SSO and MFA, integrating with existing enterprise identity and access management systems. Customer data is tenant-isolated and third-party integrations use purpose-scoped service accounts.
Data Stays on Device
The Cytara Review Assistant runs on corporate-secured devices. We apply least-privilege and data minimization principles, transmitting only the minimum required data off-device.
Encrypted in Transit and at Rest
All tool interactions are encrypted in transit (TLS) and at rest (AES-256). No one, including Cytara, has read or write access to your internal data. All access is logged and can be audited by your IT team.
Privacy and Security built in
Zero Data Retention
Cytara does not train on customer data and enforces Zero Data Retention (ZDR). Disaster recovery controls ensure availability during outages, while enforced data retention limits govern archival and secure deletion.
Enterprise Grade Security
Cytara comes with SAML 2.0 SSO and MFA, integrating with existing enterprise identity and access management systems. Customer data is tenant-isolated and third-party integrations use purpose-scoped service accounts.
Data Stays on Device
The Cytara Review Assistant runs on corporate-secured devices. We apply least-privilege and data minimization principles, transmitting only the minimum required data off-device.
Encrypted in Transit and at Rest
All tool interactions are encrypted in transit (TLS) and at rest (AES-256). No one, including Cytara, has read or write access to your internal data. All access is logged and can be audited by your IT team.
Privacy and Security built in
Zero Data Retention
Cytara does not train on customer data and enforces Zero Data Retention (ZDR). Disaster recovery controls ensure availability during outages, while enforced data retention limits govern archival and secure deletion.
Enterprise Grade Security
Cytara comes with SAML 2.0 SSO and MFA, integrating with existing enterprise identity and access management systems. Customer data is tenant-isolated and third-party integrations use purpose-scoped service accounts.
Data Stays on Device
The Cytara Review Assistant runs on corporate-secured devices. We apply least-privilege and data minimization principles, transmitting only the minimum required data off-device.
Encrypted in Transit and at Rest
All tool interactions are encrypted in transit (TLS) and at rest (AES-256). No one, including Cytara, has read or write access to your internal data. All access is logged and can be audited by your IT team.
Tailored to customer needs
We've heard all the pain points and created Cytara to address them.
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
Tailored to customer needs
We've heard all the pain points and created Cytara to address them.
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
Tailored to customer needs
We've heard all the pain points and created Cytara to address them.
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
Tailored to customer needs
We've heard all the pain points and created Cytara to address them.
“We’re pretty much always overloaded with reviews. We’re always operating past what we consider our healthy work-in-progress.”
Associate Director, Quality
Top 5 Global Biopharma
“I was in meetings for six hours today, and then I’m trying to do real review work in half-hour gaps. That’s not sustainable.”
Associate Director, Quality
Top 10 Global Biopharma
“For me, I’m almost reviewing it like grammar—are there initials, dates, boxes checked. Things that could absolutely be reviewed automatically.”
Director, Product Intelligence
Top 5 Global Biopharma
“Inspection prep is pulling documents from multiple systems, reviewing them, remembering what we wrote years ago. It’s very manual.”
Regulatory Inspection Readiness Lead
Top 5 Global Biopharma
“Some of our SOPs are 40 pages long. I don’t know how anyone efficiently flips through those to find what they need.”
Associate Director, Quality
Top 5 Global Biopharma
“[Our company’s] systems kind of suck. There are multiple systems that don’t really talk to each other.”
Associate Principal Scientist, Regulatory Affairs
Top 20 Global Biopharma
“It’s hard because documents live in different systems—EVAL, Veeva, MEDS, SAP. You’re manually pulling everything.”
Associate Director of Quality
Top 5 Global Biopharma
“Searching documents across systems is slow. Everything is spread out, and it takes forever to find what you need.”
Manufacturing Engineer
Global CDMO
"There's nothing that would irk me more than having to send something for another round of review. And each piece had four or five cycles of review."
Former Associate Director, Marketing
Top 10 Biopharma
Frequently Asked Questions
How can I trust the GxP Reviewer findings?
Every comment is tied back to source material, so reviewers can verify the basis for the finding. Cytara generates traceable annotations with supporting references, and surfaces the context behind each comment.
Is GxP Reviewer designed to replace human reviewers?
No. It is designed to act as a second pair of eyes for qualified reviewers, not replace them. It can be used as a first-pass review to detect potential issues immediately, reduce routine manual work, and cross-check source documents faster.
Can Cytara work with our internal SOPs and guidelines?
Yes. When integrated with your QMS, DMS, or ERP, Cytara automatically identifies & pulls in the supporting documents needed for each review. This allows reviews to be grounded in your internal procedures and versioned documents, not just public regulatory text.
How is Cytara deployed?
Cytara is delivered as a secure, enterprise-grade SaaS platform. It integrates with your existing systems without requiring changes to you to your current infrastructure.
Frequently Asked Questions
How can I trust the GxP Reviewer findings?
Every comment is tied back to source material, so reviewers can verify the basis for the finding. Cytara generates traceable annotations with supporting references, and surfaces the context behind each comment.
Is GxP Reviewer designed to replace human reviewers?
No. It is designed to act as a second pair of eyes for qualified reviewers, not replace them. It can be used as a first-pass review to detect potential issues immediately, reduce routine manual work, and cross-check source documents faster.
Can Cytara work with our internal SOPs and guidelines?
Yes. When integrated with your QMS, DMS, or ERP, Cytara automatically identifies & pulls in the supporting documents needed for each review. This allows reviews to be grounded in your internal procedures and versioned documents, not just public regulatory text.
How is Cytara deployed?
Cytara is delivered as a secure, enterprise-grade SaaS platform. It integrates with your existing systems without requiring changes to you to your current infrastructure.
Frequently Asked Questions
How can I trust the GxP Reviewer findings?
Every comment is tied back to source material, so reviewers can verify the basis for the finding. Cytara generates traceable annotations with supporting references, and surfaces the context behind each comment.
Is GxP Reviewer designed to replace human reviewers?
No. It is designed to act as a second pair of eyes for qualified reviewers, not replace them. It can be used as a first-pass review to detect potential issues immediately, reduce routine manual work, and cross-check source documents faster.
Can Cytara work with our internal SOPs and guidelines?
Yes. When integrated with your QMS, DMS, or ERP, Cytara automatically identifies & pulls in the supporting documents needed for each review. This allows reviews to be grounded in your internal procedures and versioned documents, not just public regulatory text.
How is Cytara deployed?
Cytara is delivered as a secure, enterprise-grade SaaS platform. It integrates with your existing systems without requiring changes to you to your current infrastructure.
Frequently Asked Questions
How can I trust the GxP Reviewer findings?
Every comment is tied back to source material, so reviewers can verify the basis for the finding. Cytara generates traceable annotations with supporting references, and surfaces the context behind each comment.
Is GxP Reviewer designed to replace human reviewers?
No. It is designed to act as a second pair of eyes for qualified reviewers, not replace them. It can be used as a first-pass review to detect potential issues immediately, reduce routine manual work, and cross-check source documents faster.
Can Cytara work with our internal SOPs and guidelines?
Yes. When integrated with your QMS, DMS, or ERP, Cytara automatically identifies & pulls in the supporting documents needed for each review. This allows reviews to be grounded in your internal procedures and versioned documents, not just public regulatory text.
How is Cytara deployed?
Cytara is delivered as a secure, enterprise-grade SaaS platform. It integrates with your existing systems without requiring changes to you to your current infrastructure.
Procurement
Manufacturing
Regulatory
Supply Chain
Quality
Commercial
Lab Operations
Get started with Cytara
Procurement
Manufacturing
Regulatory
Supply Chain
Quality
Commercial
Lab Operations
Get started with Cytara
Procurement
Manufacturing
Regulatory
Supply Chain
Quality
Commercial
Lab Operations
Get started with Cytara
Procurement
Manufacturing
Regulatory
Supply Chain
Quality
Commercial
Lab Operations