Pharmaceutical Grade Labs & Clean Room Compliance
Pharmaceutical and medical device laboratories operate under strict regulatory standards and require specialized compliance solutions to maintain industry approval. Lab Assist Inc. provides expert regulatory guidance, validation support, and cleanroom compliance services, ensuring alignment with ISO 13485, ISO 14644-2, and 21 CFR 820.
📢 Regulatory Update:
The FDA issued a final rule regarding harmonization between the CFR and ISO, which will be effective February 2, 2026. We stay ahead of regulatory changes to ensure our clients are prepared for upcoming industry shifts.
Audit Preparation & Regulatory Compliance
✔ Mock inspections & compliance gap analysis
✔ FDA, ISO 14644-2, ISO 13485, & 21 CFR 820 regulatory support
✔ Corrective actions & documentation recommendations
Instrument, Equipment & Environmental Validation
✔ Development of validation plans for new equipment & instruments
✔ Assay validation & process control improvements
✔ Cleanroom qualification & environmental validation
Cleanroom Compliance & Environmental Monitoring
✔ Air, surface, water, & climate monitoring
✔ Room classification & validation per ISO standards
✔ Monthly monitoring implementation & temperature mapping
SOP Writing & Documentation Support
✔ Development of Standard Operating Procedures (SOPs)
✔ Regulatory documentation support for ISO & FDA requirements
✔ Process compliance & training documentation updates
Our Expertise in Regulatory Standards
✅ ISO 14644-2 – Cleanrooms & associated controlled environments
✅ ISO 13485 – Medical Devices Quality Management Systems / 21 CFR 820 Quality Systems Regulation
✅ ISO 9001:2015 – Quality Management Systems
Contact
Need expert guidance for your lab’s compliance and validation needs? We’re here to help!
(562) 343-0967