2 Highwood Drive, Suite 202
Tewksbury,
MA 01876 us
Tel: 978/988-3800
Fax: 978/657-5927
Provides software that offers a controlled environment to manage all product data. The company helps medical OEMs achieve FDA 21 CFR Part 11 and Part 820 compliance by providing features such as password-protected sign-offs, authorized electronic signatures, and electronic audit trails, as well as a closed-loop CAPA system and training records management.