FDA's "Backup" in Data Integrity

 Data integrity  Backup:

"How does FDA use the term “backup” in § 211.68(b)? 

FDA uses the term backup in § 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period (e.g., § 211.180). Backup data must be exact, complete, and secure from alteration, inadvertent erasures, or loss (§ 211.68(b)). The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format. FDA’s use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation. 

Temporary backup copies (e.g., in case of a computer crash or other interruption) would not satisfy the requirement in § 211.68(b) to maintain a backup file of data."

--https://www.fda.gov/media/119267/download   page 5

The key difference appears to be the accuracy, integrity, exact nature of the data, consistent  with the meaning of archived, and PERMANENT.  As opposed to temporary backup files kept for a period of time for reference and then overwritten, which don't meet the FDA definition of "backup" in the sense of data integrity.  

-- jel@jelincoln.com

Remember, any electronic files retained as "backup", or for any other CGMP compliance reason, must be readable througout the lifetime of the record.  This means that as technology changes electronic storage media, we must either keep obsolete readers in operating condition, or migrate our archived electronic records (and readers) over to the new media / readers, in harmony with CGMP requirements for the accuracy and verifiability / validatability of such a migration.  - JEL  02/06/2023  

Is the UKCA logo similar to the EU CE Mark?

 In response to a question from one of the attendees of a recent 6 hour webinar on "The DHF, DMR, DHR, Technical Documentation - Similiarities, Differences and The Future":

Ques: Is the UKCA logo similar to the CE-2 logo:

Ans: No, not if I understand your question.  UKCA (United Kingdom Conformity Assessed) has it's own version of the CE-Mark, the UKCA (Google to see appearance). This question is tied to the larger question of how the UK is adjusting to it's own versions of the EU's CE-Marking, EU's MDR, etc.

Note the following from the UK:

https://www.gov.uk/guidance/using-the-ukca-marking

also note this item:

From 1 January 2021 the technical requirements (‘essential requirements’) you must meet – and the conformity assessment processes and standards that can be used to demonstrate conformity – will be largely the same as they are now… the UK standards will be the same in substance and with the same reference as the standards used in the EU. However, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body” -  gov.uk website

"Essential requirements" are their words, not sure if they mean that generically or not, since the EU MDR now uses "General Safety and Performance Requirements" i(EU MDR) n lieu of  "Essential Requirements"  (old EU MDD), as I explained in the webinar. 

There is also a 2 year transition period, from Jan 01, 2021 - Jan 01, 2023, in many applications.  And N. Ireland is exempt from most of Brexit, and adheres to the EU in general, while Wales and Scotland are also associated with Brexit.

Please check with your notified body for the specifics of requirements and implementation of Brexit's adjustment to pulling out of the EU, the MDR and CE-Marking.

-- jel@jelincoln.com