Assess | Validate | Optimize
Comprehensive CSV services designed to fit your unique regulatory journey
Your Path to Compliance Excellence
Why Spyre’s Services?
What Makes Our Services Different:
Unmatched Precision
GAMP5, ALCOA+, ISO 27001, and GxP built into every project.
Faster Delivery
35% reduction in project timelines, without compromising quality.
Global Coverage
Delivered across 25+ countries with local understanding and regulatory insight.
100% Client Satisfaction
We stay until you're audit-ready and beyond.
Our Core Services
1. Regulatory Compliance
Regulations never sleep — and neither do we. Spyre’s Regulatory Compliance services ensure your systems are audit-ready, your data is ALCOA+ aligned, and your operations meet the strictest standards including 21 CFR Part 11 and Annex 11.
What We Deliver
- Computerized System Validation (CSV): Validation for ERP (SAP, Oracle), LIMS (LabWare), cloud platforms (AWS, Azure). End-to-end support using GAMP5 principles — including validation planning, IQ/OQ/PQ testing, traceability matrix, and SOPs.
- IT Infrastructure Qualification: Ensure servers, networks, and SaaS platforms like Veeva Vault and Salesforce meet GxP requirements.
- Spreadsheet Validation: Validate Excel and Google Sheets to ensure ALCOA+ compliance, secure calculations, and data integrity.
- Regulatory Compliance Consulting:Tailored strategies for FDA, EMA, MHRA, PMDA, ISO 13485, and Annex 11 alignment — reducing audit risks by 45%.
Outcomes You Can Expect
- 100% audit success with major regulatory agencies
- 35% faster validation lifecycle delivery
- Savings in potential cost savings from rework avoidance and proactive remediation
- Scalable validation documentation that supports business growth
Scalable validation documentation that supports business growth
Our Process
Assess
your current systems and validation landscape
Strategize
with customized GAMP5 and ALCOA+ validation plans
Execute
IQ/OQ/PQ testing with complete traceability
Document
everything in audit-ready format
Train
your team for lasting compliance
2. Audit & Risk Management
Risks hide in plain sight — until they cost you millions. With 250+ successful audits, Spyre turns potential vulnerabilities into strategic advantages. Our Audit Risk Management services are built to identify, mitigate, and prevent compliance threats before they spiral.
What We Deliver:
- Gap Assessments: End-to-end system and facility assessments that identify compliance blind spots and close them fast.
- Third-Party/Vendor Risk Audits: Evaluate external partners against ISO, GxP, and SDLC standards to eliminate supplier-induced risks.
- Periodic Internal Reviews: Maintain FDA and EMA audit readiness with annual or semi-annual internal audits that catch deviations early.
- Information Security & Data Integrity Advisory: ALCOA+, GDPR, and HIPAA-aligned controls designed to secure sensitive data and build trust.
Outcomes You Can Expect
- Zero-finding audits, even under strict FDA or EMA review
- 45% reduction in overall operational risk exposure
- Bulletproof vendor qualification workflows
- Shortened investigation timelines with traceable reporting structures
Scalable validation documentation that supports business growth
Our Process
Plan
the audit scope, frequency, and focus areas
Assess
systems, vendors, and security practices
Report
findings with crystal-clear remediation priorities
Fix
with guided corrective actions and training
Monitor
with post-audit tracking and compliance metrics
3. Governance
Strong governance is the bedrock of consistent compliance. At Spyre, we design systems that empower your teams, accelerate approvals, and sustain regulatory confidence across operations.
What We Deliver:
- Quality Management Systems (QMS): Develop and deploy scalable, GxP- compliant QMS frameworks for multi-site global operations. Reduce deviations and harmonize quality.
- Regulatory Training Programs: Deliver engaging, effective training on GAMP5, ALCOA+, 21 CFR Part 11, Annex 11, and risk management — both virtually and on-site.
- Agile & DevOps Integration: Align governance frameworks with modern methodologies to streamline delivery cycles by up to 35%.
- Regulatory Impact Assessments: Analyze new and evolving global regulations (e.g., EU MDR, ICH, FDA) and proactively adapt systems to remain compliant.
Outcomes You Can Expect
- 60+ scalable QMS frameworks rolled out globally
- 1,000+ professionals empowered with hands-on training
- 35% acceleration in project delivery through Agile-QMS synergy
- 50% reduction in SOP errors and non-conformances
Scalable validation documentation that supports business growth
Our Process
Assess
current governance and system gaps
Design
a custom-fit governance model aligned with your industry needs
Train
your staff for real-world implementation
Align
QMS with Agile/DevOps workflows
Evaluate
regulatory impact and adjust accordingly
4. Process Development & Definitions
Process gaps are where most compliance issues begin. Spyre’s Process Development services are designed to proactively eliminate those gaps through streamlined, validated documentation workflows, ensuring your teams are always audit-ready.
What We Deliver:
- CAPA Design & Optimization: Build smarter CAPA systems that prioritize risk and prevent recurrence. Integrate with existing QMS and reduce closure cycles.
- Non-Conformance Management: Identify, document, and correct deviations with traceable root-cause analysis and escalation procedures.
- SOP Review & Streamlining: Rewrite and restructure SOPs to enhance clarity, compliance alignment, and user adoption across teams.
- Process Documentation for GxP Compliance: Ensure every process, from R&D to distribution, is mapped, governed, and traceable.
Outcomes You Can Expect
- 45% faster CAPA resolution timelines
- Clear SOPs that reduce human error and improve audit scores
- Scalable documentation that meets GxP and ISO requirements
- Reduced rework and faster deviation closures across departments
Scalable validation documentation that supports business growth
Our Process
Analyze
existing CAPA and SOP frameworks
Redesign
for clarity, speed, and compliance.
Validate
process documentation for audit alignment.
Train
teams on SOP adoption and CAPA execution
Measure
impact via issue resolution KPIs
Industries We Serve
Pharmaceuticals
From drug manufacturing to distribution
Biotechnology
Regulatory readiness for fast-moving innovators
Healthcare
GDPR, HIPAA, ISO 13485 compliance
Information Technology
CSV and infrastructure qualification
Clinical Research Organizations
Trial data integrity, GCP alignment
Ready to Win at Compliance?
Spyre has delivered results for clients in over 25 countries with a flawless audit record. You could be next.
Book a free consultation now and turn your compliance workload into a strategic advantage.