Case Studies

Good Documentation Practices (GDP)

Good Documentation Practices (GDP) are the measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.

Medical Device Contamination

In 2018, CCS began a partnership with a medical device manufacturing client in the Bay Area. Although the client's previous janitorial service provider performed daily cleaning of their cleanrooms, the areas failed to meet the client's standards and regulatory guidelines. CCS quickly identified that the janitorial staff was not trained in, lacked industry knowledge for cleanroom cleaning and disinfection, and lacked GMP experience.

Cost Savings, Time Savings, and Better Environmental Monitoring Results

CCS began a partnership with a biopharmaceutical manufacturing client in the Greater Boston area. We quickly identified that the client was using incompatible legacy equipment from a previous cleaning company and did not fall in line with GMP guidelines for cleaning cleanrooms. Leveraging our expertise and vendor relationships, CCS recommended the correct equipment that would not only yield better results but would also save them nearly $1M/year in WFI and cleaning chemicals for their contamination control program.

Contamination Challenges

At the beginning of the COVID-19 outbreak in March 2020, Seattle, WA was at the epicenter of the pandemic. CCS was agile and quickly designed a plan for our client, a leading biotech company, to keep their employees safe. We proposed our Healthy Cleaning Protocols program which included a dedicated team of Pathogen Control Specialists to disinfect high-traffic areas and critical Laboratories.

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