Study Documentation

Archiving is an important means to ensure that data and documents can be retrieved at a later stage. All essential records must be appropriately archived, in conditions that include:

• Adequate and suitable space.
  
• Access restricted to authorised named individuals.
• Secure storage facilities with appropriate environmental controls and protection from physical damage.
  

Storage media must ensure documents remain complete, legible and available throughout the required period of retention. Electronic, magnetic, optical or non-indelible media must be controlled to ensure any alterations can be traced (audit trail). For electronic storage media it is particularly important to consider the lifespan of such media (e.g. tapes, CD, SSD drives) and the accessibility of digitally stored data which were stored using specific formats, software versions or technical equipment (downward compatibility of newer systems/techniques/software). For example: are you still able to access the information you stored only a few years ago on your floppy discs?

Systems used for transfer of original documents to another media for storage must be validated (their reliability must be confirmed), and the availability of the equipment to convert records to readable format must be ensured.