Qualification

Laboratory Instrumentation

QSP offers an efficient and affordable solution for qualification of laboratory equipment that satisfies the requirements of the FDA. Our science and engineering professionals have applied laboratory experience and are well versed in GMP and GLP requirements. This in-depth understanding of the regulations and the science behind the equipment allows us to deliver the most viable solution for effective solution for your laboratory’s needs.

QSP offers affordable fixed pricing for qualification of standard laboratory equipment. All of our fixed-price services are performed by trained validation experts that provide the high-quality, FDA-compliant work you expect from QSP, but without breaking your budget. QSP experts can perform the following for most types of laboratory equipment.

• Validation Master Plans (VMP)
• Installation Qualifications (IQ)
• Operational Qualifications (OQ)
• Performance Qualifications (PQ)

Maintaining equipment and facilities can be a major distraction in the lab. When equipment is off line for preventive maintenance, calibration, qualification or repair, revenue generating work is on hold. To compound the problem, many laboratories assign analysts to perform and document these tasks which divert them from their core responsibilities. QSP laboratory support services can help by keeping equipment in optimal condition, minimizing lost opportunity time, and thoroughly documenting all tasks to avoid quality compliance issues. We assemble teams that understand your equipment, quality system and regulatory requirements to provide both routine and non-routine services.

QSP works closely with your team to write qualifications that ensure equipment is designed and installed according to your process requirements. We are proficient at writing and executing operational qualifications that confirm and challenge established tolerances. Our staff has applied experience that is well suited for developing & conducting performance qualifications to demonstrate that equipment functions consistently and meets process demands.