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#Ispeak solutions verification
#Ispeak solutions trial
#Ispeak solutions series

This should be enforced by SOPs for GDPs or use of the system, or by instruction in the testing protocols / test cases.

That people using the system are trained and made aware of the responsibility of verifying the record against the original record.

There is an electronic signature in the system at the point of entry that attests that the digital copy has been verified against the original record.

Scans of documentation are of appropriate resolution, clear and legible.

#Ispeak solutions verification

The level of verification of the true copy should be commensurate with the level of risk (i.e., if the original is easily available, or the level of regulatory oversight IQ versus PV).

This should be completed in line with “true copy principles”, and when the data is entered into the system every effort should be made to ensure:

However, in inserting original records into a digital system we must ensure that this is done in controlled manner so that the original paper record can be discarded appropriately.Difficulties associated with paper-based records such as locating hard copy documents, off site storage and recall in audits can be avoided.

This functionality allows other ALCOA++ principles to be satisfied such as:Įnduring = The data inserted electronically into a digital solution will be enduring throughout its data retention cycle, and the data will be protected against change.Īvailable = Another advantage of digital solution is that the data is available digitally at any point in the data’s lifecycle.

During testing execution activities digital solutions can be used to digitally insert evidence of acceptance criteria being met such as MOC certification, drawing walkdowns, and lab testing data.

#Ispeak solutions series

committing the data at the end of a series of actions, which reduces the number of required signatures). Other approaches maybe configured or used, (e.g. This then would enable the audit trail functionality, so that any changes to committed data are visible. In the case of a validation test this could be once you have executed a test step and confirmed the expected result (usually at the end of each row). One common approach is, as per electronic batch records, you verify and “commit” the data upon every action, and this is where the electronic signature is applied. There can be multiple options to this in a digital solution based on the set-up /configuration of the system.

There also needs to be a discussion in the organisation using the Digital solution of when the data is officially “Committed” (ie the tasks in a test case are verified by the executor).

Careful planning of test execution to Contemporaneous principles then becomes essential. The need for more education of users of the system to appreciate that everything they “commit” to system is captured and that this cannot be undone (i.e., if there is a long break between test steps this will be more visible compared to paper). This can lead to discussions with compliance on if the test is valid, even if the intent of test is not time sensitive or to be completed in sequence.

However, with this new level of transparency it is easy to derive if test steps have been done out of sequence or with significant time gaps.

Documented timestamps can be easily retrieved and shown to an auditor. This will then show that the execution of testing has been done in a contemporaneous fashion.

On one hand the system will visibly show you a timestamp of the completed activities in the system.

Digital solutions can be a double-edged sword in the achievement of Contemporaneous recording of data:.

The data in the electronic system will also be Enduring, since the data will not fade, be lost, or destroyed which are downfalls of paper-based systems, as long as the system is suitably validated and backed-up.

Another advantage of Digital solutions is that by using digital technologies we can ensure that the data entered is legible, and the old paper-based challenges associated with poor documentation of testing documents (poor GDP, handwriting, etc) are significantly reduced.

This reduces the chances of falsification of data and fulfils the Traceability aspect of the ALCOA++ principles.

#Ispeak solutions trial

One of the main advantages of digital solutions is that data, when entered into the system, is attributed to the user automatically with an electronic time stamp, and if the data is changed in any way there is an audit trial associated with the change and who made it, and when it was made.Principles as a framework, and the questions and challenges of moving from paper-based processes to a digital solution. In this Blog we explore how these paperless tools could be used enhance data integrity practises used the ALCOA++ 1