In addition to manufacturing the finest environmental mapping equipment available for conditions such as temperature, relative humidity, CO2, pressure, vacuum and conductivity; Ellab also offers validation services specialising in temperature mapping.
Our team of in-house trained, expert validation engineers provide on-site validation and qualification services globally with the best customer service in the industry. Our engineers are experts in temperature mapping and are available as a package with Ellab pre-calibrated equipment, ready to hit the ground running. We can help meet complex requirements in regulated environments with significantly reduced test equipment risk.
We offer a full range of validation services required by the life science, chemical, cosmetic, food and beverage, and hospital industries. Our services often include commissioning, qualifications and validations that are designed specifically to support a variety of industry guideline and regulation needs.
Our support ranges from the development of templates and protocols, onsite hands-on execution and management of validation projects. The support we provide is flexible and customised to meet the diverse industry needs. Our experienced validation service team is familiar with the requirements from government agencies such as the FDA, EU, ICH and will document and execute your projects at each facility with consistency, quality and integrity.
We understand how critical it is that all documentation meets current Good Documentation Practices (cGDP). And our validation experts, therefore, know what is expected and how to accurately generate these reports. Ellab’s validation report packages and summary reports are often leveraged during audits whether those are internal, customer or the local governing body such as FDA or EMA.
We provide both hard and soft copies of the following as applicable:
- Final summary report
- Temperature mapping data, humidity mapping data and more
- Executed protocol (IQ/OQ/PQ/CQ/RQ as requested)
- Test equipment and materials: Calibration certificates, pre and post verification data
- Sensor location information: Diagrams, drawings, images
- Employee training records
- Audit trails generated by our ValSuite validation and calibration software
- Standard Operating Procedures (SOP’s)