Hybrid Systems (Deleting Electronic Data)
In Hybrid systems the computerized system is used to generate a record which is printed and hand signatures applied. The decision for the regulated company is whether the electronic record (or raw data) should be kept or deleted from the system.
In the FDA Guidance “Part 11, Electronic Records; Electronic Signatures — Scope and Application” under record retention the following is stated:
FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format (examples of such formats include, but are not limited to, PDF, XML, or SGML). Persons must still comply with all predicate rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning. As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. In addition, paper and electronic record and signature components can co-exist (i.e., a hybrid situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved.
This statement is key to the determination of whether the system falls under the FDA electronic record ruling (21 CFR Part 11). For systems where a paper record is produced the decision of the regulated company is whether to keep the electronic record, or the associated raw data. Care has to be taken in making this decision and the rationale documented.
Removing (deleting) the electronic record removes the need to maintain the record and the additional overhead (effort) required to maintain the record compliantly. However the regulated company must ensure that the record is complete (that is does not rely on the electronic data).
Where the record is maintained, then the following from the guidance should be considered.
In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.
Deleting data is a big step to take for a regulated company. The regulated company must determine and document the decision as to whether the electronic data will be used for making GxP decisions.
In case you want to delete the electronic data from system, as long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. this will be true in case of static data where data is not fix and can not be changed, however original records (Electronic Records) can not be deleted in case of Dynamic data where records can be modified e.g. chromatographs.
If the electronic data is to be kept but the regulated company does not want to maintain compliance with 21 CFR Part 11, then steps must be taken to demonstrate that the data is NOT used for any GxP decisions. This can be difficult to demonstrate or control.
If you need to keep the data (for any purposes) and you cannot demonstrate that the information is not used for making GxP decisions then the record and associated data is maintained compliant with 21 CFR part 11.
Where data is not required to be kept then the data can be immediately removed from the system or archived so that it is not available for users / quality to make quality related decision on it.
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