Second-person reviews should be your first priority in ensuring data integrity. Nothing can replace a smart person who knows what can go wrong, is willing to probe data, and asks the key questions: Does that make sense? Is that reasonable? Does something look out of sorts here? A good reviewer will catch data integrity issues while they can still be corrected—and help keep your data safe, your lab compliant, and your business in good standing.
The question is, how can you help second reviewers do their jobs faster and better? What are the key considerations for maximizing their effectiveness and job satisfaction? Here is some practical advice.
1. Select the right reviewer.
The quality of the review is dependent on the person performing it, and both their experience and demeanor must be up to the task. “Experience” should include an understanding of where errors are most likely to occur in the analytical process, along with general competence with review and approval of workflows using the e-signature feature in CDS and LIMS software.
“Demeanor” could be roughly translated to mean detail-oriented with the ability to visualize and retrace the steps using the audit trail entries. Reviewing requires investigating multiple sources of data and reviewing records for accuracy. Ideally this person has the natural curiosity to evaluate data and does not simply see the task as “tedious but necessary.” That is why the best reviewer is typically an experienced scientist who knows the technical details of executing the analytical procedure.
2. Provide the right training.
Even when the second reviewer is highly experienced with e-signature workflows, sometimes they need very specific guidance on what is critical to review in this method, on this instrument. It is helpful to create a checklist of what needs to be reviewed, guiding the reviewer on where to go. For example, a thorough review typically includes looking at audit trails. If a reviewer does not know how to find those efficiently, one could devise queries to retrieve the data for them. It is also important to have knowledge of which audit trails are in the software and where they are located.
In addition, cultural training is important to underscore which actions are acceptable and unacceptable and how each will affect the reviewer’s job. For example: “Report everything that is suspicious or could impact the product’s quality.” These high-level expectations go beyond low-level tactical items such as “only do manual integration when there is something wrong with the automated process.” They communicate the importance of business integrity, not just data integrity.
Ultimately, by providing the right training you do not just improve data integrity; you also improve your overall data and result quality.
3. Present all data for second-person review.
Transparency of data is a key part of ensuring integrity in regulated laboratory operations. Some examples of excluded data that must be presented for second person review include:
- Aborted runs or aborted tests
- Orphan samples/orphan data
- Rejected runs that failed to meet system suitability or acceptance criteria
- Runs that are out of specification (OOS) or out of trend (OOT)
- Runs that are voided for any reason (dropped injections, power failure) along with supporting evidence
- Prior calculations of result values, if performed on external applications (for example, statistical programs or spreadsheets)
- Original records containing errors that have been corrected and for which both the original and corrected printouts are being resubmitted for review
4. Don’t underestimate the importance of management support.
Even well-qualified reviewers cannot be effective without the support of their managers, and that support should take multiple forms. For example:
- Managers must ensure that adequate time and priority are given to perform thorough reviews
- They must support the review’s findings even when issues arise, or changes must be made before test release
- They should minimize or eliminate their complaints about the time needed for a second-person review, especially when remediation of many systems involves additional procedural controls that slow the review; instead encourage the implementation of technical solutions that will speed up the review process
- They should provide ample recognition or rewards for good reviewers, because catching errors is an indicator of good reviewer performance rather than bad, and in all likelihood will save the company time, money, and reputational damage
5. Offer the right tools and capabilities to expedite the review process.
The capabilities of second reviewers should be complemented by capable equipment and processes. Without the right e-signature workflows, a good review can take longer than the time to perform the test. And without the right instruments and software, processes slow down, people start looking for ways to keep things on schedule, and the environment becomes ripe for data integrity issues.
On the other hand, with modern software that is optimized for the review process, many efficiencies are gained that expedite second reviews while increasing accuracy and completeness. To cite just a few quick examples, a modern CDS application such as OpenLab CDS has the technical controls and functionality to help make a reviewer’s job easier:
- Lock data after review, preventing additional changes that could undermine the trustworthiness of the reported results
- Highlight data changes and deletions to facilitate the review process
- Use the Custom Calculator tool to automatically compute unique values directly within the software, removing error-prone calculation steps and simplifying the second-person review process
- Review by exception and create efficient search routines within an individual project or the whole database to identify data trends and inconsistencies
- Document that audit trail entries have been reviewed
- Have changes made to an original record flagged, so no time is wasted looking for a nonexistent audit trail
- Print a summary of data and leave the majority of data as electronic, facilitating a quicker review process
Make your second-person review process first-rate
The second-person review is the first line of defense for data integrity. To get more information and guidance about optimizing your second-person review process, check out the related content below.