An acceptable system must satisfy the following criteria:
a. Only authorized individuals can make data entries,
b. data entries may not be deleted, but changes may be made in the form of dated
amendments which provide the reason for data change,
c. the data base must be made as tamperproof as possible,
d. the SOPs should describe the procedures used for ensuring the validity of the data, and
e. either the magnetic media or hardcopy printouts are considered to be raw data.
