Mapping and Transport Validation
Good Practices demands that an initial and periodically temperature/humidity mapping exercises are carried out on the manufacturing and storage areas, and temperature-controlled vehicles before use, under representative conditions (EU GDP directive).
FQS has a vast experience in temperature / RH mapping and transport validation and offers a robust service package that ensures a full compliance in the process.
What out costumers says about our Warehouse Validation Services
“The work was completed ahead of schedule with a very high standard”
“The Cold Chain unit was qualified on site by FQS. They performed the Installation Qualification (IQ), Operational Qualification (OQ) and the Performance Qualification (PQ). The work was completed ahead of schedule with a very high standard. The report was well presented and meeting all in-house and required regulatory requirements. Their understanding of Data integrity was excellent with all ALCOA principles clear within all their work, and CFR21 Part 11 compliant software was used. This qualification ensures our business is complaint and ensures it meets our regulatory requirements and the equipment runs efficiently and effectively.”
‘I would not hesitate in calling FQS with a compliance or temperature mapping query. FQS are reliable and always follow up punctually – I would recommend them without reservation’.”
“FQS carried out mapping for us. Their work certainly ticked all the boxes and their standard of service and knowledge of legislation and requirements was excellent. Notably, FDA Reporting was provided in a tamper proof PDF format and CFR21 Part 11 compliant software was used. Protocols and reports contained up to date relevant information meeting all the requirements of different regulatory authorities and were written in an easy read format. I found that reports were returned in a timely fashion and a logical reason was always provided for each logging position following the risk assessment of a location. ‘I would not hesitate in calling FQS with a compliance or temperature mapping query. FQS are reliable and always follow up punctually – I would recommend them without reservation’.”