Issues related to long-term preservation of electronic records
21 CFR Part 11 has a small number of requirements that are technically extremely difficult to comply with.
Long-term preservation of electronic records is another difficult issue to address.
Importance of Audit Trails
As we have pointed out many times in the past, such electronic records should not be deleted, even if they were approved on paper.
Because there is no audit trail on paper.
However, it is not easy to maintain electronic records for a long period of time.
This is because computer systems (software) are regularly replaced.
Normally, when replacing (migrating) from an old system to a new system, the electronic records would be migrated.
However, due to technical issues, few if any audit trails may be migrated from the old system to the new system.
Electronic records without an audit trail, however, cannot be subjected to inspections.
The FDA may refuse to conduct an inspection for any reason, for example, if the audit trail has been erased. In some cases, a Warning Letter may be issued.
Electronic recordkeeping requirements in Part 11
The retention period for records varies depending on the regulations of each country, but is usually 5 or 10 years. In the case of special biopharmaceuticals and regenerative medical products such as iPS cells, the retention period is mandated to be 30 years.
Moreover, it is common for some companies to stipulate retention longer than those statutory periods.
When the FDA issued a draft of Part 11 in 1994, it requested that the real thing be kept on file.
In other words, they were required to maintain a system in which electronic records were stored until an inspection could be conducted.
However, the pharmaceutical companies protested against this request. The reason is that it is unreasonable to keep the old system only for inspections.
They must continue to bear the risk of failure and the cost of maintenance, as well as licensing fees.
This was pointed out in public comments, and the FDA changed the requirement to keep “accurate and complete copies” when it issued the Part 11 Final Rule in 1997.
This means that the old system must be accurately and completely migrated to the new system, including the audit trail.
However, there is a problem with this as well. While it may be possible to replace the same software from the same manufacturer, it would be almost impossible to do so from a different manufacturer.
Incidentally, the method of preserving the old system until an inspection is conducted is called the “time capsule approach.
The method of migrating all data, including audit trails, from the old system to the new system is called the “migration approach.
That is why there is a problem whether we take the time capsule approach or the migration approach to retain electronic records.
This means that unlike paper records, it is difficult to retain electronic records for long periods of time.
Long-term preservation methods for electronic records
So what exactly did the U.S. pharmaceutical companies do to solve this problem?
It retains only a database.
All that is required at the time of the inspection is a search of electronic records. In other words, if electronic records can be easily retrieved at the time of inspection, there is no problem with FDA.
When replacing a system, the old system is discarded, but only the database is preserved.
Then, we can create SQL statements and have a tool for inspectors to search electronic records.
However, database software may also increase in version, and upgrades must be implemented accordingly.
However, the structure of the database and the data must not be changed.
Search tools should also not be able to change data.
When replacing a system, it is important to first consider how to continue to maintain the electronic records currently held.
The system should not be disposed of easily.
A system disposal plan should be prepared and adequate consideration should be given to how electronic records will be retained.
Other Methods
Today, some analytical instrument manufacturers are developing cloud services. The idea is to store raw data and other data collected by analytical instruments in the cloud.
Even if a new device is purchased, the system guarantees upward compatibility and allows handling of past electronic records on the latest device.
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