Calibration, Qualification and Validation
for Industry
ASSI Industria is specialized in calibration, qualification and validation in industrial sector, from chemical to food industry, including energy industry, OEM’s, fine chemical and APIs manufacturers as others belonging to the manufacturing chain.
In order to do so ASSI offers a qualified and specialist group of technicians for support and advice in any situation under current applicable regulations. Inquiry any quality service you may require to our specialized technicians.
Service Areas
- FOOD INDUSTRY
- FOOD ANALYSIS LABORATORIES
- FINE CHEMICAL INDUSTRY
- PRIMARY AND SECONDARY PACKAGING MANUFACTURERS
- CHEMICAL INDUSTRY
- ENERGY SECTOR
- OEM MANUFACTURERS
- Qualified and specialized technicians
- Services compliance with applicable regulations: ISO9001, ISO22000, ISO22716, ISO13485, APPCC, BRC, IFS, GxP (EMA, FDA)
- Access to your calibration and qualification plan through our CALIBWEB
- Integral Service
- Recognized company with 3 locations, Barcelona and Madrid, and more than 20 years of experience in your sector
- 100% flexibility and adaptability to customer needs
- Express Service
Commitment
Calibration
- Processes Instrument Calibration. Variables:
- Temperature
- Humidity
- Pressure
- Weight
- Chemical parameters
- Flow
- Time
- Gas Analyzers
- Electrical Signals
- Dimensional
- Strength
- Others…
- Repair and maintenance service: preventive and corrective maintenance, repair and supply of instrumentation.
- Our services: In Situ, Integral Service, BPO. Do you want more information?
- Calibration Audit Plan: audit and advice for compliance of calibration plan to applicable regulations.
- Accredited (ENAC) Calibration. Temperature, pressure, humidity, volume and isotermal means. More information in ASSI Labs
Qualification
Qualification of thermal equipment and sterilization:
Climate chambers, refrigerators, freezers, deep freezers, cold stores, stoves, incubators, vacuum ovens, ovens and muffles, steam autoclaves, ethylene oxide autoclaves, depyrogenation tunnels, freeze dryers, washers and disinfectors.
Supply Chain Validation:
Warehouses, transport qualification, packaging qualification (isothermal packaging), reception/reparation and expedition times, and way of using cold accumulators or freezing witnesses.
Qualification Service Facilities and Air Treatment Systems:
- Clean Rooms, Treatment Units and Air Filtration
- Qualification of laminar flow cabinet, biological safety cabinet, extraction cabinets, Isolators, gas-venting air flow cabinet
Qualification Activities:
- Qualification Plan (QP)
- Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
- User Requirement Specification (URS)
- Protocol writing and execution DQ-IQ-OQ-PQ
- Risk Assessment (RA)
- Final Qualification Report
- Design review and traceability matrix (DQ)
- Standard Operating Procedure (SOP) preparation
Validation
ASSI Industria is specialized in the following validation services:
- Computerized systems Validation
- Validation of IT infrastructure
- Consulting in design and installation of IT
- Validation of facilities and services
- Validation of analytical methods
- Cleaning processes Validation
- Processes Validation
- Consulting and training activities
Validation activities
- Validation Plan (VP)
- Risk Assessment (RA)
- Protocol writing and execution DQ-IQ-OQ-PQ
- Final validation report
Consulting activities
- GMP and GMP Part II implementation consulting
- GMP according ISO15378 implementation consulting
- Compliance 21 CFR Part 11 (ERES) implementation consulting
- Standard Operating Procedure (SOP) writing consulting
- Changing controls
- Updating of validation documentation
- Consulting in Quality Risk Management (QRM)
Training activities
- Validation
- GMP
- Standard Operating Procedure (SOP)