Are you confident that your production systems are performing within your SOPs?
In order to control life science product quality, you need to control the process – which includes ensuring that the critical research, development, and production equipment and chambers used in the manufacture of your products is operating accurately and correctly to the standards you have set. Non-compliance with standard operating procedures, cGMP guidelines, and FDA regulation can delay product production, costing you time, money, and reputation.
Are you confident that your installed systems are operating within your standard operating procedures? If you are constructing a new facility, relocating an existing one, or adding a new piece of equipment, are you sure that your equipment is performing to your specifications?
Masy BioServices offers comprehensive IQ / OQ / PQ validation services to ensure production confidence.
Masy BioServices’ validation services group qualifies your critical life science research and production equipment and environmental storage chambers, ensuring the highest possible quality of product development and delivery.
Our turn-key solution includes:
- writing installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols
- executing protocols
- a thorough quality review of the final documentation.
With our large, dedicated team and one of the largest fleets of equipment available, we can confidently meet or exceed your time frame requirements without sacrificing quality or accuracy. Masy’s skilled professionals can perform multiple chamber or equipment qualifications simultaneously using multiple datalogging systems, saving you precious time and money with minimal disruption to your production cycle schedule.
Results you can count on; reports you can trust.
Masy’s qualification testing provides documented evidence that your chamber or equipment is installed correctly, operates accurately, and performs reliably. At the conclusion of your project, Masy will provide a clear, comprehensive validation report, confirming that your systems are compliant to your standard operating procedures. Our reports contain all of the data necessary for you to have confidence in the operation of your equipment; each one is written to comply with your quality assurance practices, as well as cGMP and FDA requirements. Validation reports typically include:
- Executed protocol
- Real-time, hard copy, and soft copy mapping data
- Calibration certificates for all equipment used, noting NIST traceability
- Sensor calibration reports
- Personnel training records
- Summary results
- Electronic backup files for all studies
Additionally, our own credentialed Quality Department will review all reports before delivery to ensure our final product to you meets our exacting standard. We also retain a digital copy of your completed report to assist you with future audit questions, should the need arise.