Data Integrity App
Question 61:
When do I have to revalidate computerized systems? H+V February 2011
Best Answer: Computerized systems should be reviewed periodically to
confirm that they remain in a validated state. Periodic evaluation should
include, where applicable, the current range of functionality, deviation
records, change records, upgrade history, performance, reliability and
security. The time period for revaluation and revalidation should be based on
the criticality of the system.
Question 62:
What are the relevant validation efforts for small devices? H+V February 2011
Best Answer: Small devices are usually off-the-shelf pieces of equipment
that is widely used. In these cases, the development life-cycle is mainly
controlled by the vendor. The pharmaceutical customer should therefore
reasonably assess the vendor’s capability of developing software according to
common standards of quality.
A vendor assessment needs to be performed and the
application needs to be verified against the requirements for the intended use.
From the perspective of the regulated industry, the implementation of such a
device is driven by an implementation life-cycle.
At minimum the following items need to be addressed:
·requirement definition for the intended use including process limitations. This should also include a statement indicating whether data are stored or transferred to another system.
As per the definition of a small device, data are not stored permanently but temporarily and are not to be modified by a user. Therefore, limited user access handling is acceptable.
It needs to be ensured that
parameter data influencing the device's behavior may not be altered without
suitable permission;
·Risk
assessment, taking into consideration the intended use and the risk to patients
for associated with the process supported by the small device;
·Vendor Assessment;
·List
of available documentation from the vendor, especially those describing the
methodology used and the calculation algorithm, if applicable. A vendor
certificate or equivalent detailing the testing performed by the vendor may
also be included;
·Calibration
certificate, if applicable;
·Validation
plan according to the risk-assessment results;
·Verification testing proving that the device fulfills the requirements for the intended use. It may be equivalent to a PQ-phase. Small manufacturing devices are sometimes only equipped with microprocessors and firmware and are not capable of high-level administration functions.
Moreover, data is often transient in
nature in these devices. Due to the latter there is no risk of inadvertently
modifying data. An audit trail is therefore not necessary and user access may
be limited to those functions of parameter control.
Question 63:
What alternative controls are accepted in case a system
is not capable to generate printouts indicating if any of the data has been
changed since the original entry? H+V February 2011
Best Answer: As long as this functionality is not supported by the
supplier, it may be acceptable to describe in a procedure the fact that a
print-out of the related audit trail report must be generated and linked
manually to the record supporting batch release.
The sponsor should ensure that the documents listed in
chapter 8, 'essential documents for the conduct of a clinical trial' of the
guideline for good clinical practice are maintained and accessible to those
parties authorized to review them.
Question 64:
What are the
requirements for storage time of electronic data and documents? H+V February
2011
Best Answer: The requirements for
storage of electronically data and documents do not differ from paper
documents. It should be ensured that electronic signatures applied to
electronic records are valid for the entire storage period for documents.
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| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
“Stay One Step Ahead in Pharma IT Compliance”
https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity
Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.
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