Back-up

Data backup should be a priority for companies and their IT departments. The need for a data backup technology in life science companies is significant. According to the regulations of the Food and Drug Administration (FDA) appropriate security measures must be taken to prevent accidental loss of data. Particular care must be taken when data are transmitted. This requires precautions to keep data secure and protected from unauthorised access.

Backups allow business to continue operating even in the event of data loss due to disaster, theft or system breakdown. Information and data must be stored on a regular basis and can be recovered if necessary. There are several things to consider when choosing a backup system:

  • Backups should be taken at regular intervals on how frequently the system is used.
  • The backup system should meet individual requirements of a company.
  • Backups should be kept secure preferably off-site from the main business premises.

Data security is a means to ensure that data are kept safe from loss or corruption. The loss of data caused by human error is one of the biggest risks for organisations. A number of studies have shown that the loss of data is often caused by accidental deletion or malicious sabotage. As a consequence, appropriate security precautions should be taken to ensure that data is not changed without notice, e.g., as required for GxP compliance, an older file version should not be overwritten by a new file version. A file should be deleted only if it is archived or if there is no need to keep it.

As well as keeping data safe from loss, it is equally important to protect data from unauthorised access. Companies should make sure that the transfer of data to and from the server is encrypted. Particular care should be taken when choosing a password. A strong password policy should be established. Passwords should be set to expire after a certain time. If a password is incorrectly entered three times, the user account should be disabled. To provide adequate protection from unwanted intrusions, a firewall should be used.

As an additional part of data security, a data archiving solution should be in place. Click here for more information.

Back to Guidance and Regulations on SOP management systems