On Saturday, March the 12th, after 28 days in China, I was finally allowed to travel to Suzhou.
I took a taxi to be COVID19 safe. I met Amber Ting briefly outside the Neo building before heading to the Suzhou quarantine facility. Due to the increase in COVID19 cases in Shanghai, new rules apply to people entering Suzhou.
On March the 15th, we met the CAP audit team for the first time! This is a good start to the process. Well done to Amber for her presentation. Below is the progress of the preparation; almost there!
I was able to meet the entire team on March the 24th! Such a great time together.
The CAP inspection of the Suzhou lab occurred on the 19-20th April, with Zero deficiencies and zero remarks. It was such a Global team effort! Congratulations to everyone.
The inspectors said the organization made everything very smooth. They said the lab is well organized, and we have set a high standard bar. They have been impressed, from their previous experience auditing international sites, that we are one of the best.
The milestones were achieved thanks to the non-counted hours of work for everyone to make sure that everything was perfect, already quite at the level of ISO15189 (and we applied the 19th to CAP15189):
It has been a long journey from Suzhou lab buildout planning to actual CAP inspection. The Suzhou team has worked so hard overcoming all the challenges of new site buildout during Covid 19 era.
On April the 22d, after 43 PCR tests in 11 weeks of the trip, I was flew back home, which was a real adventure in itself; during the time Shanghai was fully locked down, a high-speed train from Suzhou to Shanghai station, then a taxi to Pudong airport. Only two flights that day left from Shanghai.
I will end my second travelogue by warmly thanking the entire China team for their warm welcome and hard work in preparing the CAP inspection to ensure everything was perfect. In addition to, Amber Ting, for her help defining the best strategy for my trip, given the daily COVID19 regulation changes, to make sure we follow them.
