Validation Services
Importance of Regular Instrument Qualification
Instrument qualification (also called validation or calibration) is a critical process that provides proof of result reliability as required for compliance purposes. It also has the added benefit of determining whether an instrument needs maintenance before it fails.
Three Types of Qualifications
IQ (Installation Qualification)
An Installation Qualification is performed during the installation of new or modified instrumentation. It is required after a move or purchase of a new or pre-owned instrument. It provides documented evidence that a system meets all manufacturer installation requirements.
OQ (Operational Qualification)
An Operational Qualification is performed after any major changes to the instrument. It is often performed in conjunction with a PQ (or PV). An OQ involves testing the instrument’s performance under ‘worst-case scenario’ conditions and comparing the results to predetermined specifications.
PQ (Performance Qualification)
A Performance Qualification or Verification is executed in conjunction with an OQ. Both these protocols examine modular performance and overall system performance. It involves testing the instrument under real-world conditions and comparing its performance to predetermined specifications.
Why Outsource Instrument Qualification?
Some laboratories have their own calibration teams who perform instrument validation periodically on the equipment. However, for many laboratories, it is more logical to outsource their instrument qualifications.
Some reasons include:
- It is more cost-effective for small to midsize labs to outsource rather than hire a calibration team.
- An independent third-party source for qualification removes any potential conflict of interest and can consequently ensure compliance. This is often the preferred option for regulatory agencies.
- Many third-party sources are able to perform advanced repairs, which is useful to address any failures during OQPQ/OQPV. For instance, at ALPHA-1, we are able to address any repair on the spot, no matter how advanced the repair is, preventing costly downtime.
- In many scenarios, outsourcing your lab qualifications is more cost and time-effective.
What to Expect from an ALPHA-1 Equipment Qualification
Our hardware and software validation/calibration services are beyond compare and follow recognized standards and specifications. Ideal for labs that need more than the OEM can offer, specifically custom validation protocols (SOPs) meeting all your requirements. When you qualify an instrument, whether newly purchased, after performing a PM, after a repair, or after a move, you can count on our experts to perform the work professionally, in a timely manner, and according to your standards.
We perform all recognized qualification procedures, including Installation Qualification (IQ), Hardware Operational Qualification Performance Verification (OQPV), / Operational Qualification Performance Qualification (OQPQ). We also perform software IQOQ according to your requirements, or we can provide our own custom protocols.
Our validation services are available on both a time and material basis and as part of a service agreement. Time and material may be ideal for labs undergoing moves or upgrades but are not looking for long-term insurance on their instruments. However, due to the critical nature of validation, we recommend a service agreement, including validations, to provide long-term assurance. If you are interested in purchasing our validation services, please contact us today, and we will have one of our consultants get back to you within one business day.