Reduce deviation risk and audit exposure with documented reliability architecture. Protect controlled environments, prevent environmental drift, and support compliance reporting—with infrastructure designed for validation.
Free assessment · Compliance-ready documentation · Phaseable deployment
15 minutes. Map your compliance risks. Get an audit-ready summary.
Who it's for: GMP and medical-grade manufacturing facilities concerned about audit exposure and deviation risk from power events. What it solves: Provides documented, phaseable reliability architecture that protects controlled environments, prevents environmental drift during power events, and delivers compliance-ready documentation for auditors and regulators. Next step: Book a free 15-minute Risk & Uptime Assessment to get your Controlled-Environment Risk Map and executive-ready compliance summary packet.
Watch how the Compliance Uptime Infrastructure Plan protects your operation
Power events become compliance events. Compliance events become business events.
Per deviation investigation (direct + opportunity cost)
Of documentation burden per environmental excursion
Observations for inadequate environmental controls
Every power event creates a documentation trail. Auditors and inspectors look for patterns. Multiple environmental excursions signal inadequate infrastructure—turning routine audits into investigations.
When power fluctuates or fails, HVAC systems cycle. Cleanrooms lose pressure. Temperature and humidity drift outside spec. Every minute of drift is a minute you have to document, investigate, and defend.
Your validated processes assume stable infrastructure. When the infrastructure fails, you're not just investigating a power event—you're questioning whether the process remained in a validated state.
Deviation investigations consume quality resources. Each event requires root cause analysis, impact assessment, CAPA development, and executive review. Your quality team spends weeks on paperwork instead of quality improvement.
The timing windows are closing. The scrutiny is increasing.
Regulators are coming. Your infrastructure documentation should be ready before they arrive.
Near-misses are warnings. The next event might not be a near-miss.
Build reliability into your expansion. Retrofitting is harder than building it right.
Carriers are asking harder questions. Documented infrastructure reduces premiums and risk.
Three steps to compliance-ready infrastructure.
15-minute call to map your controlled environments, compliance requirements, and documentation needs. We create your Risk Map.
We develop your phaseable reliability roadmap with deviation prevention strategies and audit-ready documentation.
We deploy during planned maintenance windows, prioritizing your most critical controlled environments. Full IQ/OQ documentation included.
Built for compliance-critical environments. Documented for auditors.
The Compliance Uptime Infrastructure Plan delivers documented, phaseable reliability architecture specifically designed for regulated manufacturing. Unlike generic power solutions:
Your complete Risk & Uptime Assessment includes:
Focused call to understand your controlled environments, compliance requirements, and regulatory timeline.
Visual mapping of your critical areas and where power events create the most compliance exposure.
Strategies to prevent environmental excursions and mitigate impact when prevention isn't possible.
Realistic timeline for protecting critical areas first, with expansion path for full-facility coverage.
Professional documentation package suitable for regulatory submissions, insurance reviews, and executive presentations—ready for your next audit.
If we can't produce an audit-ready mitigation summary from assessment inputs, you receive the written packet free—no strings attached.
From regulated facilities that stopped worrying about infrastructure gaps.
Controlled Environment Assessment: [Overview of controlled areas assessed]
Risk Identification: [Summary of deviation risk factors]
Mitigation Recommendations: [Phased approach summary]
Compliance Documentation: [IQ/OQ protocol overview]
This multi-cleanroom facility experienced 4-6 environmental excursions per year due to power events, each requiring 40-80 hours of quality team investigation time. After deploying infrastructure reliability systems, they achieved [X] consecutive months with zero power-related deviations. [PLACEHOLDER: Include specific metrics on deviation reduction, audit outcomes, or documentation time savings.]
"[Quote from Quality Director or Compliance Director about audit readiness, reduced deviation burden, or regulatory confidence.]"
"[Quote from VP Manufacturing or COO about operational confidence, documentation quality, or ROI from avoided deviations.]"
Phase 1 protection for priority controlled environments typically deploys within 90-120 days. If you have an imminent audit, we can prioritize documentation deliverables to support your preparation even before physical installation.
You receive professional documentation in both PDF and editable formats, structured for easy integration into your existing quality management system. Documentation follows standard pharmaceutical/medical device formatting conventions.
Yes. If you've received observations related to environmental controls or business continuity, our documentation package can support your corrective action response by demonstrating a systematic approach to infrastructure reliability.
Complete the form below for your comprehensive Risk & Uptime Assessment.
Get your free assessment and audit-ready compliance summary—before your next inspection.
Book a 15-minute Risk & Uptime AssessmentQuestions? Email us at compliance@forerunnerenergy.net