How Can Digital Validation Solutions Enhance Data Integrity, and What Are the Challenges to Be Aware Of
Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt digital solutions with the promise of improved data integrity and more compliant execution of testing activities.
In this Blog we explore how these paperless tools could be used enhance data integrity practises used the ALCOA++1 principles as a framework, and the questions and challenges of moving from paper-based processes to a digital solution.
- 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. This reduces the chances of falsification of data and fulfils the Traceability aspect of the ALCOA++ principles.
- 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. 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.
- Digital solutions can be a double-edged sword in the achievement of Contemporaneous recording of data:
- On one hand the system will visibly show you a timestamp of the completed activities in the system. This will then show that the execution of testing has been done in a contemporaneous fashion. Documented timestamps can be easily retrieved and shown to an auditor.
- 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. 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. 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). Careful planning of test execution to Contemporaneous principles then becomes essential.
- 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). There can be multiple options to this in a digital solution based on the set-up /configuration of the system. 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. 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). This then would enable the audit trail functionality, so that any changes to committed data are visible. Other approaches maybe configured or used, (e.g. committing the data at the end of a series of actions, which reduces the number of required signatures).
- 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. This functionality allows other ALCOA++ principles to be satisfied such as:
Enduring = The data inserted electronically into a digital solution will be enduring throughout its data retention cycle, and the data will be protected against change.
Available = Another advantage of digital solution is that the data is available digitally at any point in the data’s lifecycle. Difficulties associated with paper-based records such as locating hard copy documents, off site storage and recall in audits can be avoided.
- 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. 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:
- 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)
- Scans of documentation are of appropriate resolution, clear and legible
- 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.
- That people using the system are trained and made aware of the responsibility of verifying the record against the original record. This should be enforced by SOPs for GDPs or use of the system, or by instruction in the testing protocols / test cases.
- Another benefit of digital solutions is the enhanced accuracy of the electronic records versus paper. In a digital solution the data “committed” is protected from change via an audit trail in line with data integrity principles. Paper processes don’t have the granularity of an accurate timestamp, and you must rely on training and SOP adherence for documenting changes to records in a compliant way.
- The functionality in digital solutions ensures that other data integrity principles are enhanced:
- Complete = All data “committed” has an audit trail, and no pre-approved data can be deleted. Also, the audit trail has the original and any changed data.
- Consistent = Sequencing of events have a date / timestamp (so generally if executing a sequence of test steps, you will have a timestamp of completion at the end of each step).
From the above discussion you can derive how paperless systems can be used to enhance data integrity compliance., There are still key considerations that need to be addressed around how Contemporaneous and Original aspects can be achieved with the use of these systems.
- 1ALCOA++ stands for : Attributable Legible Contemporaneous Original Accurate ++ = Enduring /Available /Complete /Consistent /Traceable