See how Ideagen FastStart Packs deliver enterprise-grade quality management without the enterprise timeline or cost. Request a demo to explore your industry-specific pack and discover why growing SMEs choose FastStart over lengthy implementations.
FDA/EMA-ready quality management in 45 Days. Not 6 months.
Don't let regulatory compliance delay your market entry. Ideagen's FastStart Pack for Life Sciences eliminates the guesswork in FDA/EMA compliance with proven workflows that have passed regulatory scrutiny across multiple successful implementations. All with pricing below £20,000 per year.
Pre-validated. Audit-ready. Regulatory-approved.
Our FastStart Pack for Life Sciences delivers everything you need for FDA, EMA, and ISO compliance, without the complexity or cost of traditional implementations.
Comprehensive regulatory standards coverage
Comprehensive regulatory standards coverage
Pre-validated workflows for FDA 21 CFR Part 820, ISO 13485, EMA requirements, plus ISO 9001, 14001, 45001, 15189, and 17025. Compliance frameworks designed by regulatory experts with audit checklists for all standards.
OOS/OOT investigations and change control
Advanced CAPA templates for Life Sciences
Change management (permanent and temporary), critical/major and minor/other non-conformance tracking, complaints, and opportunities for improvement. Specialized Out of Specification/Trend (OOS/T) investigation templates with multi-level investigation workflows.
All core quality capabilities included
Complete QMS modules
Document control, audit management, training, supplier management, asset tracking, customer management, and administration. All pre-configured with dynamic permissions, automated workflows, and compliance templates.
The challenge for Life Science companies
Complex FDA/EMA regulations requires specialized expertise
Navigating 21 CFR Part 820, ISO 13485, and EMA requirements demands regulatory expertise most SMEs lack. Pre-built compliance frameworks designed by regulatory experts ensure adherence to all requirements without expensive consultants.
Lengthy validation processes delay launches
Traditional validation consumes 6+ months and delays time-to-market. Pre-validated system components reduce validation timeline from 6+ months to 4-6 weeks, accelerating your market entry.
Keeping up with changing regulatory requirements
Regulations evolve constantly, requiring ongoing updates to quality systems. Regular updates to workflows and templates ensure ongoing compliance as regulations change.
Audit preparation consumes a lot of time
Preparing for FDA or EMA inspections diverts critical resources from product development. Automated documentation trails and inspection-ready reports ensure continuous audit readiness without manual preparation.
The FastStart solution
Regulatory expertise embedded in every workflow
Purpose-built with regulatory expertise in every workflow. You get the same level of compliance assurance that Fortune 500 pharma companies rely on—proven frameworks that have passed regulatory scrutiny across multiple successful implementations.
45-day path to regulatory compliance
While competitors struggle with 6+ month validation cycles, you're operational in 45 days. Pre-validated system components that regulatory bodies recognize and trust eliminate traditional validation delays.
Price certainty
Implementation below £20,000. Reduce dependency on expensive regulatory consultants while ensuring continuous compliance with automated checks and inspection-ready documentation.
Built to scale from startup to enterprise
Start with essential functionality for emerging biotech, then scale to enterprise pharma on the same platform. Built on technology trusted by 75% of global pharma companies.
Over 16,000 customers trust Ideagen.
Built for FDA 21 CFR Part 820, ISO 13485, and EMA
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Comprehensive regulatory compliance
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Life Sciences specific investigation workflows
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Complete QMS modules
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Inspection-ready audit management
Eliminate regulatory compliance gaps
✓ Operational FDA/EMA-compliant QMS in 45 days, not 6+ months
✓ Pre-validated workflows regulatory bodies recognize
✓ Reduce validation timeline from 6+ months to 4-6 weeks
✓ Automated documentation trails for inspections
✓ Eliminate manual tracking and spreadsheets
Compliance without consultant fees
✓ Pricing below £20,000 per year
✓ Save £100K+ annually vs. regulatory consultants
✓ Continuous audit readiness from day one
✓ Predictable annual subscription costs
OOS/OOT management that satisfies regulators
✓ Multi-level investigation templates (1a, 1b, 2, 3)
✓ Batch disposition and product impact assessment
✓ Automated compliance checks prevent violations
✓ Complete traceability for regulatory inspections
✓ Built-in controls that pass FDA/EMA scrutiny
Ideagen FastStart Packs get you operational in 30 days with pre-validated workflows and compliance-ready processes. See the difference for yourself.
900 +
hospitals and healthcare facilities
75%
of global pharma companies
65%
of the world's biggest food and drink companies
90%
of the top aerospace and defense companies
Compare Your Options
Which approach is right for your business?
Compare Ideagen FastStart Packs against traditional competitor implementations and manual quality management. See why growing SMEs choose pre-configured, compliance-ready solutions that get them operational in weeks, not months.
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Life Sciences FastStart Pack |
Competitor solutions |
Manual processes |
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Implementation under 6 weeks |
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Pricing below £20,000 |
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Multi-industry pre configuration |
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Complete audit trails & traceability |
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Automated workflows & approvals |
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Pre-validated for regulatory compliance |
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2-day expert training included |
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Scales to enterprise without migration |
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Real time quality metrics & dashboards |
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Electronic signatures & 21 CFR Part 11 |
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Life Sciences FastStart Pack
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Implementation under 6 weeks
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Pricing below £20,000
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Multi-industry pre configuration
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Complete audit trails & traceability
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Automated workflows & approvals
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Pre-validated for regulatory compliance
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2-day expert training included
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Scales to enterprise without migration
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Real time quality metrics & dashboards
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Electronic signatures & 21 CFR Part 11
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Competitor solutions
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Implementation under 6 weeks
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Pricing below £20,000
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Multi-industry pre configuration
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Complete audit trails & traceability
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Automated workflows & approvals
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Pre-validated for regulatory compliance
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2-day expert training included
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Scales to enterprise without migration
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Real time quality metrics & dashboards
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Electronic signatures & 21 CFR Part 11
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Manual processes
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Implementation under 6 weeks
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Pricing below £20,000
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Multi-industry pre configuration
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Complete audit trails & traceability
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Automated workflows & approvals
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Pre-validated for regulatory compliance
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2-day expert training included
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Scales to enterprise without migration
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Real time quality metrics & dashboards
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Electronic signatures & 21 CFR Part 11
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Need a different FastStart pack?
Ideagen FastStart Packs are also available for 9001, Healthcare, Medical Devices and Manufacturing.
ISO 9001 Pack
Multi-standard compliance for ISO 9001, 14001, and 45001. Pre-configured CAPA workflows and audit checklists get you certification-ready in 30 days.
Healthcare Pack
Designed for hospitals and healthcare facilities. Quality management that meets Joint Commission standards without disrupting patient care operations.
Manufacturing Pack
Built for production environments needing ISO compliance. Quality workflows that enable operations instead of creating bottlenecks.
Medical Devices Pack
Purpose-built for medical device development. Complete design history file workflows with integrated risk management and regulatory submission support.
FAQs
Answer: Traditional implementations start from scratch with lengthy discovery, requirements gathering, custom configuration, and extensive testing - consuming 6-12 months. FastStart Packs start with pre-configured, pre-validated workflows proven across hundreds of implementations. You're deploying best practices, not reinventing them. While competitors are still in discovery workshops, you're operational.
Answer: While every company thinks their requirements are unique, 80% of quality management follows standard patterns dictated by regulations like ISO 9001, FDA 21 CFR Part 820, or Joint Commission standards. FastStart Packs handle the regulatory structure that's common across your industry - document control, CAPA, audit management, training. You can adapt specific workflows for true differentiators while building on a proven compliance foundation that auditors recognize and trust.
Answer: Absolutely. FastStart Packs are built on the same enterprise-grade Ideagen platform used by Fortune 500 companies with 50,000+ employees. You start with right-sized functionality for 10-250 employees and scale seamlessly as you grow—no migration required, no platform changes. We scale when you do.
Answer: Everything: industry-specific configuration for your chosen pack (ISO 9001, Life Sciences, Healthcare, Manufacturing, or Medical Devices), all core QMS modules (document control, CAPA, audit management, training, supplier management, change control), pre-validated workflows and compliance templates, 2-day expert-led training covering administration and operations, and ongoing platform access. 5 admin licenses and 10 user licenses. Additional licenses and configurations are avaialble on request.
Answer: We offer five specialized packs: ISO 9001 (covering 9001, 14001, 45001 for general manufacturing), Life Sciences (FDA 21 CFR Part 820, ISO 13485, EMA, ISO 15189, 17025), Healthcare (Joint Commission, CMS requirements), Manufacturing (production-focused ISO compliance), and Medical Devices (FDA, ISO 13485, EU MDR). Each pack includes industry-specific workflows, compliance templates, and audit checklists.
Answer: Most organizations are operational within 30 days. Once you share your user and departmental information, we configure the system and deliver comprehensive 2-day training covering system administration, management, and day-to-day operations. The pre-configured nature of FastStart Packs eliminates traditional implementation delays - no lengthy discovery, no extensive customization, no months of testing.
Answer: You receive ongoing platform access, regular feature updates, and technical support as part of your annual subscription. The system is yours to manage and customize as your needs evolve. Additional training, advanced configurations, and integration services are available as needed, but the core system is ready to use from day one.
Ready to learn more?