1. Security
โข Data entered or amended - authorized persons supported by Password Support Policies
โข Security systems to prevent unauthorized entry or manipulation of data
โข SOPs for entering data, changing or amending incorrect entries and creating back-ups
โข Regular back-ups of all files and data
โข Secure storage (prevent intentional or accidental damage
โข Security procedures in writing
โข Regular back-ups of all files and data
โข Secure storage (prevent intentional or accidental damage)
โข Disaster Management and Data Recovery Plan
โข Audit trail:
โข identify the persons who made entries
โข identify the persons who made changes
โข identify the persons who released material
โข identify the persons who performed other critical steps in production or control
