Validation Services
Sampled’s validation services provide a robust documented analysis of your equipment’s performance capacity. Our team uses state-of-the-art equipment to provide you with a wealth of data to demonstrate operational performance and regulatory compliance.
What Are Sampled’s Validation Services?
Sampled’s validation services provide a thorough test of equipment performance and functionality.
For example, we test multiple locations within a piece of equipment over a typical twenty-four-hour period to demonstrate compliance with internal or regulatory standards. This provides a wealth of evidence for our client to present to regulators and auditors. Our highly trained technical services engineers also perform validation testing on new and existing equipment to ensure optimal performance and compliance.
Why Use Sampled’s Validation Services?
Expertise
Sampled’s validation services team has broad expertise in the operation of drug/sample testing equipment. In fact, we were the first global company to offer ICH stability testing outsourcing, so we know everything about how these machines work and how to validate them within regulatory standards.
Robust Documentation
At Sampled, we perform the same tests that we outsource validation support for. This means we understand the level of documentation needed to satisfy regulatory bodies. By working with Sampled, you can be sure that our thorough documentation will satisfy an auditor or regulatory body.
Reliability
Our validation services team uses only state-of-the-art equipment that is traceable to national standards. By staying ahead of the curve with Sampled’s validation services, your equipment will run more consistently with less chance of excursion.
Collaborative Approach
Here at Sampled, we see our clients as collaborative partners and are fully invested in ensuring the success of their projects. Given our expertise and experience, we can provide a highly consultative service, sharing our wealth of knowledge to help you succeed.
Applications for Validation Services
We serve a wide variety of clients across the life science, medical device, BioTech, pharmaceutical, and cosmaceutical sectors.
Our validation services support applications such as:
- Drug testing
- Clinical trials
- Cosmetics testing
- Nutraceutical testing
- Vaccines
- Medical device testing
- Drug discovery
- Research studies
- Sample storage
How Do Validation Services Work?
New equipment
New equipment purchased by our clients requires validation to ensure the equipment matches the description and operates and performs as described and to regulatory standards. Older equipment also requires regular validation to ensure regulatory compliance.
IQ – Installation Qualification
Our validation team inspects your new equipment to ensure it physically matches the description given by the supplier. This includes but is not limited to checking the chamber’s mechanical and electrical installation, features, and installed options.
OQ – Operational Qualification
Our team confirms that your new equipment matches the operational description provided by the supplier. This includes but is not limited to the achievable range of temperature, humidity, and light exposure, and the operational functionality of the installed components.
PQ – Performance Qualification
We test the performance and accuracy of your new equipment using multiple temperature and humidity probes. We test the extremes to ensure that the new equipment is regulation-compliant.
Sampled offers a yearly renewal of this validation program so our clients can show regulators they are consistently meeting requirements.
Input Requirements for Validation Services
Our technical team is ready to perform validation services on a range of equipment linked to sample/drug testing. This includes but is not limited to:
- Fridges
- Freezers
- ULT Freezers
- ICH stability rooms/chambers
- Incubators
- Photostability cabinets
- Warehouses
Find out more about our validation services
Have you purchased new chambers but lack the equipment and expertise to validate it? Want to ensure your older equipment is still in working order? Get in touch with Sampled’s team of experts today to discover how we can meet all of your validation needs.
