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Electronic Records Life Cycle

The electronic records life cycle has several stages: 1) Creation, where initial records are generated from activities and must meet requirements. 2) Access, use and reuse, where records are stored and accessed to inform work. It is important records remain authentic, trustworthy and reliable during this stage. 3) Migration, which is the transporting of records between systems, such as due to obsolescence. It must be well documented to ensure data integrity and meaning are preserved.

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3K views2 pages

Electronic Records Life Cycle

The electronic records life cycle has several stages: 1) Creation, where initial records are generated from activities and must meet requirements. 2) Access, use and reuse, where records are stored and accessed to inform work. It is important records remain authentic, trustworthy and reliable during this stage. 3) Migration, which is the transporting of records between systems, such as due to obsolescence. It must be well documented to ensure data integrity and meaning are preserved.

Uploaded by

dinesh pharma
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Electronic Records Life Cycle

Introduction
E-records, as information objects, have a life cycle that begins “from initial
data generation and recording, through processing (including transformation
or migration), use, retention, archiving, and retrieval.Ӡ
The life cycle is needed to understand the controls necessary to properly
manage e-records and ensure their integrity. Failure to address just one
element of the data life cycle will weaken the effectiveness of the computer
control systems‡ and the e-records integrity–related controls.
Figure 3.1 depicts a typical data life cycle.§ The typical stages associated
with the e-records life cycle are: creation, access, use and reuse, migration,
and physical deletion.
Note that the business requirements that underlie the e-records handling
requirements drive the selection of appropriate supporting technologies. The
technologies pose questions associated with ongoing internal and external
secondary access to records, support the selection of appropriate technologies,
and identify important system migration issues.

Creation
Initial e-records are generated during the Creation Stage as the result of activities.
Some activities have defined boundaries. This means they have a start and
an end point, during which information is recorded either by human action or
by technology, such as process control and data acquisition, on a real-time basis.
There are two important elements during the Creation Stage. One,
whether the raw e-records meets the requirements defined by business
policy, governmental regulations, and by law. Two, that the raw e-record is
correct, reliable, and accurately represents the particular activity recorded.
The “data” collected during the Creation Stage is considered to be “work
in process” similar to draft documents.
An e-record becomes a CGMP record when the e-record is generated to
satisfy a CGMP requirement. The e-record must save “the data at the time of
performance to create a record in compliance with CGMP requirements

Access, Use, and Reuse


During the Access, Use, and Reuse Stage the records are stored and accessed
for information on the particular activities they document. During the period
of record-keeping, information must be authentic, trustworthy, and reliableinform the work of
the principal stakeholders. During this period, it is
important that the recorded information is stored in either processing (initial
creation of records) or retention (storage of records) environments.
According to Medicines and Healthcare Products Regulatory Agency
(MHRA) terminology, the data in the processing environment is raw data,
whereas the data in the retention environment is known as a true copy.
Records retained in original processing environments are accessible by
the tools and mechanisms used to create them. This means the raw data
is easily modified. Although records are retained in their original processing
environment, record authenticity, trustworthiness, and reliability are not
solely a function of record access, but also access to tools and mechanisms
associated with the creation of the original data. Should records require
modification, it is imperative that compulsory change documentation procedures
are in place to preserve an audit trail of changes throughout the
period of time specified by the retention schedule.

Migration†
Data migration is the transporting of e-records from one system to another,
or the transition of data from one state to another. It can occur either in the
active or inactive phase of the e-records life cycle.
If system obsolescence forces a need to transfer e-records from one
system to another, the process must be well documented and its integrity
verified. If e-records are transferred to another data format or system, validation
should include checks that data is not altered in value and/or meaning
during data migration. Conversion of data to a different format is also considered
to be data migration.
Migrated data should remain usable and retain its content and meaning.
Risk assessment is a key instrument in data migration. The system owner
should ensure system audit trails, electronic signatures, and metadata remain
intact after migration. It is the system owner’s responsibility to maintain the
link between the readable audit trail, electronic signatures or metadata, and the
audited data.

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