Qvalitek provides practical validation, qualification, consulting, training, and digital compliance services for regulated industries. We help companies ensure that facilities, equipment, processes, and computerized systems are reliable, compliant, and fit for their intended use.
Validation and Qualification
We support companies with professional validation and qualification services from planning to final reporting. Our work is based on a clear, risk-based approach and practical documentation.
Our services include:
- Cleanroom validation and classification
- Biosafety cabinet qualification
- Isolator and hot cell qualification
- Cold chain validation
- Refrigerator and freezer qualification
- Warehouse qualification and temperature mapping
- Compressed air and gas system validation
- Sterilization validation
- Cleaning validation
- Process validation
- Computer system validation
- DQ, IQ, OQ, and PQ documentation
Digital Quality and AI Compliance
We help companies manage digital systems in line with regulatory and data integrity requirements. Our digital compliance services focus on computerized systems, electronic records, electronic signatures, and reliable digital workflows.
Our support includes computer system validation, GAMP 5-based documentation, user requirement specifications, risk assessments, testing, data integrity review, and compliance with EU GMP Annex 11 and FDA 21 CFR Part 11 principles.
Consulting and Training
We provide consulting and training services to help your team understand regulatory expectations, improve internal processes, and prepare reliable documentation.
Our support includes validation planning, risk assessments, SOP development, protocol preparation, audit readiness, and tailored training for quality, production, engineering, and validation teams.