VALIDATION AND TEMPERATURE MAPPING

A complete qualification process

Hanley Validation department offers the complete qualification process for all controlled temperature or humidity areas or units.

Full Qualification Service

Our Validation department offer the complete qualification process for all Controlled Temperature or Humidity Areas or units. From new installation to requalification of existing units, Hanley can provide a bespoke service to suit your company’s requirements.

We offer a number of Temperature Mapping, Validation and CQV solutions, including:

  • CQV Resource Hire with Equipment
  • Full Qualification Services
  • Re-Qualification Services
  • Large Warehouse and Area Qualifications
  • Extreme Temperature Qualifications (-196 to 1200°C)

We use high quality data logging equipment that allows for stable and highly accurate measurements within different validation processes. All our equipment is fully 21CFR Part11 compliant and we supply a report package which satisfies all regulatory requirements for IQ, OQ, PQ and general validation studies.

With over 500 data loggers measuring Temperature, Humidity, CO2 and pressure we are able to manage even the most demanding project schedules.

WHAT WE OFFER

We provide end to end solutions

Project Planning

Validation Master Plans

User Requirement Specifications

Risk Assessment

Protocol, SAT, FAT and Summary Report Generation

Traceability and Calibration Matrix’s

Installation, Operation and Performance Qualification

Commissioning and Start Up

Document Review

We implement both wired and wireless solutions to ensure as little interruption to the production process as possible and our temperature equipment which covers a range of -196°C to 1200°C.

Our real time wireless data logger range means that we can see results as they are happening on site or remotely. This ensures that results can be monitored throughout the process which will ensure issues are spotted immediately.

We specialise in the mapping and validation of Controlled Temperature Units (Fridges, Freezers, Incubators), Warehouses, Autoclaves, Cold Rooms, Water Baths, Cryogenic Freezers and Lab areas.

Hanley pride itself when it comes to document preparation and execution. We create bespoke documents which tie in with the requirements of the customer and our flexibility and experience ensures that the signed off report will be fully auditable and compliant.

What makes us the best

  • >160 Technicians and Engineers at our disposal for large or small scale projects
  • Already working with the majority of blue chip companies across Ireland, UK, and Europe
  • Over 500 wireless data loggers at our disposal with the ability to see data in real-time
  • Bespoke protocols and reports to suit the clients’ needs
  • All equipment is qualified and fully 21 CFR compliant and validated
  • Extensive experience in the qualification of new build sites and the execution of thermal mapping projects on fridges, freezers, incubators, warehouse, cold storage, and cryogenic freezers
  • Experienced in the management of tight deadlines, innovation and long term ideas for support services.
  • All staff are CxP compliant, trained and experienced
  • All staff are qualified and have NSAI Temperature Mapping of Enclosures training completed.
  • High Staff retention rate amongst calibration and validation staff with one of our core values being our people
  • Experienced in the generation, delivery, and management of on-site KPI ratings
  • Provide regular on-site operations meetings with Hanley Management
  • Ability to adhere to schedules while also having the flexibility to adjust based on customer needs
  • Transparency – No additional costs or hidden fees. All costs are based on the full completion per unit
  • No hidden charges for inductions, site training, or extra charge for call-out work (within reason)
  • Our aim is to maintain zero audit findings by any regulatory body on any site based on our paperwork.
It is always a pleasure to work with the accounts department! Keep up the good work!
Working with your technician has been excellent, he has been flexible, available and knowledgeable, very supportive and always with a smile in his face. You have a good one there!
Technician willingness to be so flexible and put his shoulder to the wheel should be recognised and is greatly appreciated.
Technician is always very flexible and continually plays a vital role in day to day operations, but in this case she went above and beyond what was expected of her. Her work is greatly appreciated.
I want to recognise the efforts by Hanley Calibration in coming up with a very effective solution to a calibration repeatability problem on our site. Excellent innovation and leadership shown. Well done.
Outstanding Service provided in an exceptionally difficult year for the service. On behalf of the Validation and Facility Teams and the Organisation in general.