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Animal Health Questions and Answers Archive

Question (Quasar, October 2010)

We were issued with the following comment in our last facility audit, see below:

Need to define a procedure regarding archived electronic media being checked for timely retrieval and readability.  The IT Manager will support the required hardware (availability dependent) for read accessibility. 

Questions I have are:

  1. Who is responsible for checking stored media?

  2. In what time frames do they need to be checked?

  3. Is this a compulsory requirement according to OECD, CVM, FDA, etc.?

Answer

Thoughts on the matter are that the archiving of electronic media is a can of worms with no universally accepted solutions. I refer the reader to the excellent articles in Quasar, July 2009 No 108 by Tam Woodburn and Sheri Perlstein, Marian Mutch, and KiKuyo Minegishi available on the BARQA website. From which some of the following comment has been unashamedly plagiarised.

The first thing is that not having a procedure to manage archived electronic media would be a major non-compliance if observed by an inspector -  it is better having a procedure that is not perfect than none at all. You are then in the area of challenge to content and justification.

It is the responsibility of the archivist to ensure the integrity of the media under their management in the archive. But the archivist will need to have controls over what they accept in the first place. A CD should have a full inventory of type, attributes and content - numbers of files, file size, etc. The baseline information against which integrity can be checked.

Electronic data will decay but no one knows how long it will take. Today’s media is a lot more stable than the scaremongers would have us believe. I have media on CD checked every 5 years. Simple routines are used to check physical condition, check against the inventory and some files. Select what to check on the basis of risk.

No authority is defining specific requirements as far as I am aware, they wouldn’t would they? But there are requirements to ensure the integrity of archived data, e.g. in VICH GCP:

8.4       Retention of study documentation.

8.4.1    All study documentation should be stored in a manner that protects it from deterioration, destruction, tampering or vandalism in accordance with the nature of the records....... 

The few guidelines I can give are.

  1. always use the best computer durables, e.g. branded rather than cheap CD/DVD's
  2. use tried and tested technologies
  3. where possible migrate data to non-proprietary electronic format for storing files, e.g. PDF, XML or SGML, these are open source formats and should have a long life, free from the vagaries of a manufacturer to leave a format obsolete
  4. If data derives from GxP equipment/systems then critical meta data including audit trail information should be archived too
  5. Information should be retrievable in human readable form in a timely way as you have indicated in your finding

e-Archiving options to protect against obsolescence and degradation are:

  • mothballing hardware and software - not advised
  • migrate data to a new format if the old format is becoming obsolete, this can be done repeatedly as long as a defined validated procedure is used
  • archive in standard formats, see point 3 above
  • emulation where the original data is maintained but new systems can read it, ref Microsoft Word emulation programs to bring old and non- Microsoft documents into Word
  • transfer data to paper or other none e-data - defeatist approach.

References are:

GAMP Good Practice Guide: electronic data archiving

ISO 18492 Long term preservation of e-document based information

ISO 15489 Information and documentation - records management

There are companies that provide facilities for e-archiving, these solutions are not cheap and may not provide a 100% service, but are worth considering.