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| Data Integrity App |
Question 11:
Is a user allowed to carry out a reintegration?
Best Answer: As
far as I can see, the answer to this is 'no'. This should first be authorised
by the Head of Laboratory stating the reason.
Question 12:
The calibration of equipment influences the correctness of
data. Does this mean that the calibration is critical?
Best Answer: Since the calibration influences the patient safety only
indirectly no audit trail review is required.
Question 13:
It is difficult to carry out the separation between the persons
of administrator and user in the CDS. Is it possible that the admin and
the user being the same person?
Best Answer: This is possible but it needs to be described in a SOP.
Question 14:
Deletion is possible outside the software. How is it possible
to "build in" safety?
Best Answer: Yes, in systems that can store locally on the HD of the user it is possible to
set up two local user profiles. Then, for instance, the system stores data only
on the profile the user cannot access.
Question 15: What do you do with legacy equipment? If no audit trail is
available or if "user login" is not possible?
Best Answer: The systems
have to be replaced in the short or in the long run - according to the risks.
Question 16: What other points are included in the Periodic Review?
Best Answer:
- Roles and Responsibilities
- Service Agreements
- Validation/Qualification and Project Deliverables:
- System Control Procedures
- Audit Trail management
- Incidents, Problems
- Changes, Upgrades
- Security, User Access, User Administration
- User Guides
- Backup, BCP, Performance, Reliability Monitoring
- System Access Training
- Archived Data
When assessing the criticality of data the influence of the
data on the data integrity is mentioned as one criterion apart from the
influence on the product quality. There seems to be a direct influence on the
integrity of data almost always. How can this criterion be further
substantiated in order to be able to use it in a differentiated way?
Best Answer: This is like going round
in circles. The quality of the product always is of the highest importance. The
criterion "data integrity" by itself is not meaningful but has to be
specified by attributes such as "access security", "duration of
storage until destruction" etc.
Question 18:
What type of
accuracy checks are expected for the use of spreadsheets?
Best Answer: Data integrity should be ensured by suitably implemented and
risk-assessed controls. The calculations and the files should be secured in
such a way that formulations are not accidentally overwritten.
Accidental input of an inappropriate data type should be
prevented or result in an error message (e.g. text in a numeric field or a
decimal format into an integer field). So-called 'boundary checks' are
encouraged.
Question 19:
What measures are
required to ensure data security of databases?
Best Answer: Data security includes integrity, reliability and
availability of data. During validation of a database based or inclusive
system, consideration should be given to:
· Implementing
procedures and mechanisms to ensure data security and keeping the meaning and
logical arrangement of data;
· Load-testing,
taking into account future growth of the database and tools to monitor the
saturation of the database;
· Precautions
for necessary migration of data (annex 11 p17) at the end of the life-cycle of
the system.
Question 20:
How often should the
readability and accessibility of data be checked?
Best Answer: The period should be defined depending on the risk. Readability should be checked immediately after copying and then depending on the medium used.
“Trust but Verify “ Ronald Reagan
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- Checklist for inspection
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