AL Engineering
Consultancy focused on pharma, biopharma/biotech and medical devices with more than 20 years of experience. Services include qualification and validation of facilities, equipment and processes; regulatory compliance and audits (EU/US); cleanroom and environmental monitoring; quality management system support; supplier documentation; and risk analysis.
Industries
Nr. of Employees
small (1-50)
AL Engineering
Services
End-to-end support for validation planning and execution (VPL, URS, DQ/IQ/OQ/PQ, FAT/SAT, RTM, protocols and reports).
Internal and supplier audits; compliance assessment and implementation support for EMA/FDA, MDR/IVDMDR and 21 CFR requirements.
Design and execution of environmental monitoring programs, routine monitoring, sampling strategy, trend reports and cleanroom validation (ISO 14644 references).
QMS implementation, optimization, training and support for standards such as ISO 9001 and ISO 13485 and CE-technical file preparation.
Preparation of supplier-facing documentation including QPP, FAT/SAT documentation, IQ/OQ/PQ packages, RTM and SOPs to meet customer and authority requirements.
Execution of FMEA/FMECA and HAZOP analyses and support for ISO 14971-based medical device risk management.
End-to-end support for validation planning and execution (VPL, URS, DQ/IQ/OQ/PQ, FAT/SAT, RTM, protocols and reports).
Internal and supplier audits; compliance assessment and implementation support for EMA/FDA, MDR/IVDMDR and 21 CFR requirements.
Design and execution of environmental monitoring programs, routine monitoring, sampling strategy, trend reports and cleanroom validation (ISO 14644 references).
QMS implementation, optimization, training and support for standards such as ISO 9001 and ISO 13485 and CE-technical file preparation.
Preparation of supplier-facing documentation including QPP, FAT/SAT documentation, IQ/OQ/PQ packages, RTM and SOPs to meet customer and authority requirements.
Execution of FMEA/FMECA and HAZOP analyses and support for ISO 14971-based medical device risk management.
Expertise Areas
- Qualification & validation lifecycle management
- Regulatory compliance (EMA/FDA, MDR, 21 CFR)
- Cleanroom and environmental monitoring
- Quality management systems (QMS) and audits
Key Technologies
- FAT/SAT/IQ/OQ/PQ testing and protocols
- Cleanroom classification and environmental monitoring
- Risk analysis techniques (FMEA/FMECA, HAZOP)
- Process control and PLC/SCADA systems
News & Updates
Profile interview celebrating a consultant's 10-year anniversary covering transition from laboratory technician to consultant and company culture.
Profile of the company founder discussing company history, growth and strategic supplier agreements.
Article summarizing production, contamination and environmental considerations for adopting single-use disposable processing equipment.
Profile interview celebrating a consultant's 10-year anniversary covering transition from laboratory technician to consultant and company culture.
Profile of the company founder discussing company history, growth and strategic supplier agreements.
Article summarizing production, contamination and environmental considerations for adopting single-use disposable processing equipment.