Module 12 2019

ALCOA Plus = CCEA

C omplete: All data are present, nothing has been deleted (evidence in audit trail) C onsistent: Data are recorded chronologically with date and time (evidence in audit trail) E nduring: Data are accessible for an extended period of time (~20 years)

A vailable: Data are accessible over the lifetime of the product

Data accessibility is an area where RA has influence – because it is a requirement systems must be linked to ensure compliance.

The Organisation for Professionals in Regulatory Affairs