COMPUTER SYSTEM
A SOP should be made available for use.
An alternative method to be used during system breakdowns must be
known. Hard copies should be available even when documentation is
electronically maintained.
Maintenance and continuous operations must be ensured.
Personnel must be trained.
Validation of system and integrity and security of data entry should be
ensured.
Back up should be available.
The records required by Drugs & Cosmetics Act should also be
maintained as hard copies.