Regulatory & Compliance
Compliance is not a static milestone; it is an ongoing operational commitment that protects your product, your patients, and your business.
Cleanroom facilities operate within a complex web of international standards and regional regulations. Lapses in compliance can lead to product recalls, regulatory fines, and facility shutdowns. CleanTech Facility Services provides the technical guidance needed to navigate ISO 14644, FDA 21 CFR, EU GMP Annex 1, and USP 797/800 standards with confidence.
We help you translate abstract regulations into actionable operating procedures (SOPs), ensuring your facility is always "audit-ready."
Audit Prep
Mock audits and gap analysis for FDA/GMP readiness.
SOP Dev
Validation-grade Standard Operating Procedures.
Validated Docs
Compliant record-keeping and log management.
Navigating Global Standards
Our compliance experts specialize in synchronizing your facility operations with the strictest industry frameworks:
- ISO 14644-1:2015 Particle Classification
- FDA / CGMP Validation (IQ, OQ, PQ support)
- EU GMP Annex 1: Manufacture of Sterile Products
- USP <797> & <800> Pharmacy Compounding
Our Compliance Approach
- Risk-based contamination control strategies (CCS)
- Technical writing for cleanroom SOPs and cleaning logs
- Change control assessment for facility modifications
- Technician qualification and training documentation
Comprehensive Compliance Services
We provide the specialized oversight needed for high-stakes environments where compliance is the foundation of quality.
Gap Analysis & Risk Assessment
We conduct thorough site inspections to identify physical and operational vulnerabilities. Using FMEA (Failure Mode and Effects Analysis) and other risk assessment tools, we prioritize remediation efforts based on their impact on product sterility and regulatory standing.
Audit Readiness Programs
Don't wait for a regulator to find a flaw. Our "Mock Audit" services simulate the intensity of an unannounced FDA or ISO inspection, testing your team's gowning discipline, documentation accuracy, and environmental control performance.
SOP Optimization & Training
Static SOPs often fail during real-world operations. We develop streamlined, clear, and validated work instructions tailored to your specific process equipment and facility layout, ensuring technicians can execute tasks with 100% repeatability.
Regulatory Focus
- Data integrity & ALCOA+
- Operator health & safety
- Environmental protection
- Sterility assurance level
Our Core Assets
- Certified ISO auditors
- GMP subject matter experts
- Technical writing team
- Compliance-only focus
Safeguarding Your Reputation
CleanTech Facility Services acts as an independent compliance partner, providing the objective technical data needed to support your Quality Assurance (QA) and Quality Control (QC) teams. We turn compliance from a hurdle into a competitive advantage.
Request a Quality Audit
Concerned about an upcoming inspection or looking to baseline your existing cleanroom operations? Contact our compliance specialists to schedule a confidential gap analysis.
SCHEDULE A QUALITY AUDITPreparing for an FDA Inspection?
CleanTech Facility Services provides the documentation and operational support needed to ensure audit success.