To comply with GMP guidelines and 21 CFR Part 11 requirements, pharmaceutical companies need to guarantee the full traceability of critical data and the ability to secure access to this data. According to guidelines, a computerized system should consider electronic records, electronic signatures, and handwritten signatures executed to the electronic record to be trustworthy and reliable.
Life Sciences Supply Chain Management provides:
Out-of-the-box electronic signature requirements for GMP-critical activities and information, including the manual reset of batch disposition code and modifications of the shelf life dates for batches and sub-batches.
Extended electronic signature parameters, including the validity of electronic signature passwords and lock-out of users.
A security compliance engine to define security rules for forms, fields, and buttons based on queries and record values.
Inquiries and reports on the roles assignment modifications.