How to find the next level of connectivity in a modern lab with data integrity

The digital transformation of laboratories brings many advantages, but also new challenges for laboratory staff. Two major challenges are to ensure the integrity of data and the seamless integration of lab instruments into the IT landscape.

In a free webinar now available on demand, software solutions expert Sebastian Weber, from Sartorius, talks about why data integrity has become a hot topic in digitized laboratories and how to overcome the problems associated with integrating instruments into your lab environment. He also explains how to maintain data integrity when documenting instrument results in your paperless lab.

Below are highlights from the live Q&A discussion at the end of the webinar:

Q: What is an Alibi Memory?

SW: Alibi Memory is a special memory for balances or scales. The Alibi Memory is unsecure memory but is protected against manipulations. It's also legally approved memory for balances where all measures, weights are archived or stored; together with a unique number or identifier.

You can also print these identifiers on your weighing slips or to transfer these identifiers together with the weighing results to a LIMS system. This gives you the traceability to go back to the original results for comparison. In some countries, especially in America, it's also known under the name DSD (data storage device) memory.

Q: Is it required to sign in and authenticate all invalid data? How can you control the second copy of copies of data?

SW: When you have invalidated data, you should always sign these. It should also be documented with the reason why the data was invalidated. For example, when you have made a mistake, this should be documented together with the signature, date and time. Also, you should have a second person review of all these invalidations.

A second copy, or a copy, should be compared against the original. If it's equal, you should also sign the copy and mark it with a phrase like ‘exact copy’.

For electronic files, you can also use an algorithm to compare the files and make sure that both copies are identical. This can be a hash algorithm like MD5, so you build over the original one, and to copy hash value, and when both hash values are the same, you know that these copies are exactly the same.

Q: How can you deal with network segregation, for example, a laboratory network versus a business network?

SW: This is not really my role because I'm more on the instrument side, but for security reasons, it makes sense that you separate your office network and your laboratory network with the firewall. I recommend discussing this with your IT department to address this.

Q: Does the electronic signature in Adobe Acrobat comply with data integrity regulations for primary data?

SW: I'm not a product expert for Adobe Acrobat. But I know that Adobe has published a white paper or app note for this where they compare the Adobe signature function against the 21 Part 11 and where you also can see that this is compliant. As I'm not an Adobe specialist, I recommend having a look on their website homepage and finding this white paper.

Q: Is the Cubis balance compatible with LIMS systems other than the STARLIMS? What availability is there?

SW: We have different availabilities with LIMS system. The Cubis balance is designed as an open instrument which means that we have standard IT protocols inside the balance — not open in the sense that you can do everything on the device. This allows you to adapt or integrate the balance directly into your laboratory IT landscape, without any middleware between LIMS and balance.

For the Cubis balance, in most cases, we connect it to a LIMS interface called RESTful Web Services. In the RESTful Web Services, you find these interfaces in LabWare, in STARLIMS and different kinds of LIMS system.

It's easy for the LIMS provider to integrate our balance into their LIMS system and to establish bidirectional communication with the LIMS. For older systems, the Cubis balance also supports the old serial interface, but you also can easily transfer weighing values into the LIMS system at the modern standard to integrate as a web service interface.

Q: You mentioned that the instrument synchronizes every two hours. If there's data generated during this time, how is this affected if the time needs to be updated?

SW: Normally, this should not occur because I would say, the clock runs stably over one month inside the balance. The two-hour check is enough to make sure that the balance runs every time at the correct time.

There should be no effect because we know when we make these synchronizations every two hours, our internal clock works, so it's like there is no time gap between two hours.

Maybe we cannot be 100% sure that there is no effect because time drift can occur, but then you would see it in your auditory review.

When reports are generated, you see when the new timestamp was set by the automatic clock synchronization. You have the possibility to trace back this time difference between the synchronized time and see the time on the report via the audit trail.

Q: What should the timestamp in the audit trail contain?

SW: The exact format is defined in your SOP. We know that different countries’ timestamps are formatted differently, sometimes day/month or month/day. This should be configured to your needs on the instrument. It is also important that you don't have only the timestamp and the date.

You should also have the time zone where the instrument is located. For global companies, you may transfer results from different sites in different countries and this lets you have the chronological order for the results by including which time zones it was recorded in.

Q: If a user is both a lab user and an administrator for the instrument, can they have a single user role?

SW: No. In this case, you should have two different user roles for the assignment of tasks to fulfill this. With a computerized lab system, it should have a user account only for office administrators who should be able to complete administrative tasks, but not operative. On the other hand, you should have a role only for your operating users who are not allowed to do the administrator’s tasks.

Sometimes you have a lab manager who may need to complete both administrative tasks and operative. They should have two different user accounts for each purpose. You have an identifier in the field user description or username, for example, wording like ‘administrator’ to directly identify in the audit trail what was the user role when the task was performed.

Q: What about the second signature, which is needed in most of the cases? Can the approver, for example, a lab manager log into the instrument and set his signature at a later stage?

SW: This depends on the processes, so we can do individual workflows, design on the balance and in these individual workflows. You have also the possibility to have two signature steps. The first step is the normal creator signature, and the second step is then the approval signature. This can be done in individual workflows on the balance.

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