GRC Built to Manage Risk from Lab to Market
Archer centralizes regulatory obligations, evidence, and risk across your organization so you stay audit-ready and inspection-prepared at every stage of your product lifecycle.
Trusted by 1,500+ enterprises · 70+ countries · SOC 2 · ISO 27001
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1,500+
Clients across 48 countries
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50%
Of clients in the Fortune 500
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65%
Of organizations putting more effort into quantification
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15,000+
Members in the Archer risk community
Constant pressure, compliance and scrutiny
Life sciences companies face relentless regulatory demands from FDA, EMA, and GxP standards. While AI governance has shifted from emerging concern to active requirement, data integrity and supply chain oversight require more and more audits. This demanding environment results in risks of delays, warning letters, recalls, or market bans.
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Stringent global regulations (FDA, EMA, ICH, GCP, GMP/cGMP, GLP) with constant rule changes
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ALCOA+ data integrity and traceability across product lifecycle
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AI governance now a defined regulatory requirement with FDA-EMA guiding principles
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Third-party and supply chain compliance oversight across CROs, suppliers, distributors
Everything you need to stay inspection-ready
Archer delivers enterprise capabilities for companies of all sizes.
Obligations library and mapping
Compile FDA, EMA, ICH, and GxP standards into one structured library and link each obligation directly to your policies, SOPs, and controls.
Data integrity and audit trails
Store and version-control critical compliance documents with full change history to maintain ALCOA+ principles and satisfy inspection requirements.
Regulatory change intelligence
Automatically flag new FDA guidances, EMA updates, and ICH standards so teams know exactly which controls and documents need updating.
Built to solve life sciences compliance challenges
Archer is specifically designed to meet the needs of GRC teams and business users.
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Global regulatory coverage
Map controls once to FDA CFRs, EMA guidelines, ICH GxP standards, and ISO certifications and keep them continuously monitored.
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ALCOA+ data integrity
Maintain audit trails, version control, and document traceability across R&D, manufacturing, and clinical trials to satisfy inspection requirements.
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Third-party compliance
Track supplier, CRO, and distributor certifications, audit results, and compliance questionnaires in one system to prevent supply chain gaps.
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Closed-loop risk and CAPA
Log deviations, trigger investigations, assign corrective actions, and link outcomes back to controls so your CAPA process is fully documented.
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Innovation governance
Anticipate emerging compliance needs in AI governance and data ethics as regulations e faster than frameworks.
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Single source of truth
Replace fragmented spreadsheets and siloed tools with one integrated system that connects obligations, evidence, risk, and audit workflows.
How Archer works across your compliance program
Obligations management
Compile FDA CFRs, EMA guidelines, and ICH standards into one library, map each to your policies and SOPs, and track fulfillment with linked evidence so audits are fast and defensible.
Data integrity and audit trails
Store validated policies, protocols, and training records with full version history and change logs to satisfy ALCOA+ principles and inspection requirements.
Regulatory change monitoring
Automatically scan for new FDA guidances, EMA updates, and ICH standards; alert responsible teams; and suggest which controls and documents need revision.
The images used above are not actual product screenshots.
What your team gains with Archer
Archer enables an integrated strategy across your risk and compliance functions.
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Inspection-ready documentation
Demonstrate how every FDA, EMA, or GxP requirement is satisfied by your procedures and controls with evidence instantly at hand.
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Faster compliance audits
Cut audit prep time by up to 40% with complete, timestamped evidence trails and reusable documentation.
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Proactive risk management
Catch deviations, supply chain gaps, and regulatory changes before they become inspection findings.
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Reduced non-compliance risk
Stay current with global regulations automatically so approval delays, warning letters, and recalls stay off your risk register.
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Simplified vendor oversight
Maintain one inventory of third parties, track certifications and audits, and assess GxP compliance across your supply chain.
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Scales with your organization
Onboard new sites, products, and regions without rebuilding your compliance program from scratch.
Why life sciences teams choose Archer
See how Archer ‘s life sciences focus compares to generic GRC tools and manual compliance processes.
Generic GRC tools
Built for compliance-first enterprises without life sciences depth.
Here’s what you get
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Basic framework templates
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Standard control mapping
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Generic evidence collection
Archer
Purpose-built for life sciences regulatory complexity.
Here’s what you get
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FDA, EMA, ICH, GxP coverage
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ALCOA+ data integrity
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Automated regulatory change scanning
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Closed-loop CAPA workflows
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Third-party compliance tracking
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Life sciences audit readiness
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Integrated risk management
Manual spreadsheets
Fragmented tracking across spreadsheets, shared drives, and email.
Here’s what you get
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No audit trail
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No change history
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No automation
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No evidence linkage
Explore Our Case Studies
Eastern Bank Uses Archer to Drive Business Processes and Streamline Compliance
- View case study:
- View case study: Banorte Bank Gains Accurate Picture of Risk with Archer
- View case study: Intuitive Surgical Migrated to Archer SaaS for their journey to empowered risk management
- View case study: Operational Resilience for Financial Services Institutions
More than 1,500 organizations run on Archer®, including half the Fortune 500 and 37 of the top 50 global banks. See what their teams were up against, what they built, and what changed.
Eastern Bank Uses Archer to Drive Business Processes and Streamline Compliance
Banorte Bank Gains Accurate Picture of Risk with Archer
Intuitive Surgical Migrated to Archer SaaS for their journey to empowered risk management
Operational Resilience for Financial Services Institutions
Trusted by the teams who carry the risk
Risk, compliance, and audit leaders on what changed after Archer Evolv.
We recognized the need for a GRC software platform that would be central to our ability to improve and transform our enterprise risk and compliance processes.
Archer is the source of truth, and it creates a nice audit trail for us. As an insurance company, we're audited by every governmental entity. Now we can say, here's our repository, take a look.
Risk aggregation is a big point for us, to see where our risk is located within the organization, and to give greater visibility for boards and executives.
Turkcell is using Archer as the main GRC tool in the company. It provides us a transparent and safe governance framework.
Archer gives us the ability to boil things down into numbers and specifics versus generalities. It's management by fact versus intuition or feel.
It connects all the different applications together, so you can use those cross-references and connections to make better business decisions, because you have it all in one place.
Questions about Archer for life sciences
Answers to what pharmaceutical and biotech compliance teams ask before choosing Archer.
Yes, Archer ships with FDA, EMA and ISO guidelines coverage so you can link your controls once to all relevant requirements.
Archer stores validated documents with full version history, change logs, and audit trails so you maintain ALCOA+ principles and satisfy inspection evidence requirements.
Yes. Archer’s horizon scanning automatically flags new FDA guidances, EMA updates, and ICH standards and alerts teams on which controls need revision.
Yes. You can maintain supplier inventories, track certifications and audit results, send assessment questionnaires, and flag GxP compliance gaps.
Archer provides a fully integrated system to manage compliance and operational risk processes. Audit, compliance, BC/DR, third party risk, IT and security teams can use it to share data, build workflows and create reports for analysts and executives.
Yes. Archer offers 200+ native integrations and an open API so you connect quality systems, ERPs, and other tools you already use.
