Viedoc VIRP Webinar Q&A
This video is a recording of the Viedoc VIRP webinar, part of the "Working Smarter series":
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Validation, impact assessment and training of new releases
Q: For a new release/version 4.xx: how much is retested? If all – then what testing tools do you use? If only relevant parts - how is it documented what is selected for retest?
A: Retesting occurs at different levels during the development and release process.
During the development of new functionality, unit tests are written and executed. Additionally, all unit tests are automatically rerun daily to ensure ongoing stability.
Before each release, Performance Qualification (PQ) is conducted to verify that the software is fit for use by customers running their studies. Both unit tests and PQ tests must pass for a release to proceed.
The outcomes of unit tests, PQ tests, and other validation activities, along with their corresponding results, are documented and published in the Validation Summary Report within VIRP.
Q: Do you need to do an assessment per each new version per study or is it enough with one overall assessment.
A: As a best practice, two types of assessments should be performed:
Detailed Assessment: This involves a closer examination of the company, its procedures, and its products to ensure compliance and quality.
Risk-Based Assessment: This type of assessment, recommended by regulatory authorities, evaluates potential risks associated with the release.
For each new release, if you are already familiar with the product, a risk-based assessment is generally sufficient. This allows you to determine whether the release impacts your operations or compliance without requiring a full detailed assessment.
Q: Can you give an example where the new release did affect a study? (Since most new functions are turned off)
A: There are small adjustments we make that are not turned off by default. For example, correcting spelling mistakes in the software will automatically apply even to ongoing studies, as this typically does not disrupt users. Another example is export capabilities; we occasionally add new export options or filters to provide additional ways to export data. These updates are also applied to ongoing studies, as they generally don’t require training and end users benefit from having these features available immediately.
However, in general, any changes that require retraining or significantly alter how the system looks or functions in detail are turned off by default. This ensures that users are not impacted without proper preparation.
Q: How customers get trained for the new functionalities released for each release?
A: Alongside the release, we publish corresponding eLearning materials to support users. Additionally, we provide walk-through videos to guide you through the new features. If further training is needed, you can also reach out to our support team for assistance.
Inspection Readiness with VIRP
Q: Have any Viedoc customers used VIRP during inspection and what was the outcome?
A: We have had customers share their experiences of using VIRP during their inspections, and no observations were filed regarding Viedoc.
Viedoc is available to support customers during their inspections. Please let us know if you need any assistance, and we will be happy to help.
Q: There are many documents in VIRP. What would be the best way to read it? Which document would you suggest to start off with for users who did not know VIRP before?
A: The VIRP introduction is the best starting point as it provides key descriptions of the documents included in VIRP. After reviewing the introduction, you can focus on the document that interests you the most. For example, the Traceability Matrix which is hundreds of pages long, offering a detailed deep dive if you want to explore all the specifics about testing. If you require even more detailed information, please feel free to contact us—we’re happy to assist.
Q: Has Viedoc Technologies been inspected by the authorities and what was the outcome?
A: We have not been directly inspected by the authorities. However, we have been on-call to support customers during inspections they have had. One Viedoc customer in particular is inspected annually by the FDA. To date, all outcomes have been positive, with no observations filed regarding Viedoc.
Delegation to CRO from Sponsor
Q: As a sponsor we should be well acquainted with the Viedoc system. Can we delegate this responsibility to the CRO?
A: As per Regulations, responsibilities can be delegated to an appropriate service provider (CRO, for ex.). However, The Sponsor is always ultimately responsible for all aspects of a clinical trial.
Quoting GCP ICH E6:
“A sponsor may transfer any or all of the sponsor’s trial-related activities to a service provider in accordance with applicable regulatory requirements; however, the ultimate responsibility for the sponsor’s trial-related activities, including protection of participants’ rights, safety and well-being and reliability of the trial data, resides with the sponsor.”
In conclusion, delegation is possible with respect to a computerized system used in clinical trials (usage, knowledge, validation activities). The delegation of responsibilities needs to be clear and documented within an appropriate agreement between the responsible parties involved.
However, the full oversight and responsibilities during all the clinical trial remain the sponsor’s responsibility, requiring a quality management procedure in place, a good knowledge of the computerized system and the application of a risk-based approach to ensure safety, well-being of the participant and high quality of clinical data, when evaluating and validating a service provider.