The Difference between Electronic Records Retention and Archiving

Q. In a recent audit, we received an observation because we do not have a standard operating procedure (SOP) for the archiving of electronic records. We keep our electronic data and records on our live systems. Why would we need such a procedure?

A. The short answer is because the regulations stipulate this. “For new systems, a Validation Summary Report for each computerized system should be in place and state (or provide reference to) at least the following procedure for data archiving (processes and responsibilities), including procedures for accessing and reading archived data” (1). It is, however, sensible to look at the reasons behind this requirement and why it is also good business sense to have such a SOP in place. Data and records that are governed by the healthcare regulations must be retained and be available throughout the mandated retention periods for the respective records. In the case of clinical data, this can be 25 or more years, and for manufacturing records (paper or electronic), this is typically five or more years.

Over such a period of time, almost every computerized system undergoes modifications for a variety of reasons. These include patching the system (e.g., for security), installation of new software modules (e.g., for enhanced usability), system upgrades, system retirement, or system replacement. Any of these changes may or will affect the electronic records in the system. Depending on the impact, it can or will be necessary to remove the records from the system and store them in an archive.

Despite best intentions and good planning, there is always the possibility of an unexpected need to archive electronic records. That could be because of an unforeseen system failure or because the system performance falls below acceptable levels. It is not acceptable to wait until such an event occurs to write a procedure for the archiving of records and data; instead, it is essential to prepare the SOP well in advance.

Archiving electronic records is rarely trivial. Simply printing out the records is unlikely to either assure the entire record is captured or to be compliant with the regulations (paragraph 7.7.2 in reference 2). Archiving must take into consideration the regulations for automated systems and the guidance on data integrity. Especially:

• If data are transferred to another data format or system, validation should include checks that data are not altered in value and/or meaning during this migration process (2)
• Data may be archived. These data should be checked for accessibility, readability, and integrity (2).
• Practical guidance has been published by various regulatory authorities (3,4) and industry associations (e.g., Appendix O1: Retention, Archiving, and Migration in reference 5).

In summary, having an electronic-records archiving SOP in place is not only a regulatory requirement, but it also makes sense from a business perspective. After all, you want to be sure that you can access your data and records throughout their lifespan and to be certain that the values and information therein is still correct and complete. Writing the SOP, however, is only a first step, implementing the process and validating it are the necessary and logical next steps.

References

1. PIC/S, PI 041-1, 1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PIC/S July 2021).
2. PIC/S, PE 009-16 (Annexes), GMP Guide Annex 11
   (PIC/S Feb. 1, 2022).
3. FDA, Data Integrity and Compliance With Drug CGMP
   Questions and Answers, Guidance for Industry (2018).
4. MHRA, ‘GXP’ Data Integrity Guidance and Definitions
   (MHRA, March 2018).
5. ISPE, GAMP Guide: Records & Data Integrity (ISPE,
   March 2017).

About the author

Siegfried Schmitt is vice president, Technical at Parexel.

Article details

BioPharm International
Vol. 35, No. 7
July 2022
Page: 50

Citation

When referring to this article, please cite it as S. Schmitt, “The Difference between Electronic Records Retention and Archiving,” BioPharm International 35 (7) (2022).