Expert Insight: Data integrity and the next level of connectivity in a modern lab

Sebastian Weber discusses the hot topic of digitized laboratories and why you should consider integrating software into your workflows

19 Jan 2021

Software solutions expert Sebastian Weber, Sartorius

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.

Find highlights from the Q&A session below or watch the whole webinar on demand. 

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: Can a lab user and an administrator be added to the instruments? Can they only have one role?

SW: Our instruments don't allow multiple user roles, only one username and one role. For situations where some people in the laboratory have both operator and administrator duties, you should define some rules for the username. For example, giving them one username, e.g. username_administrator, where they use this for only the administrative work. Then, they can have another username without any additional information to use for daily work. 

When you use this concept, you can directly see the audit trail, so you can determine: ‘This was done under the username with the administrator flag. Therefore, we should take a deeper look because here they can make some changes in the system. Here they only used a standard username, and this has no capability to make system changes. Let’s take a detailed look at the activities, to see what they have done with this username.’

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

SW: During data generation, there is no effect here because we only sync the time when there is no reporting process occurring. That means when we have a running reporting process, we do not make any system time changes. If after the change we have to adjust the time, or after printing the document, you will be able to recognize it in the audit trail.

Q: You mentioned that serial interfaces directly to lab systems have the risk of not sending data if the cable was unplugged. How is this prevented if the cable were to be unplugged in the STARLIMS Cubis setup that you mentioned in the last slide on the drying example?

SW: For all our connectivity interfaces, we use a very intelligent solution to detect connectivity problems. If it's a connection to the STARLIMS system, if it's the transfer of a PDF document to a file server, or is it sending a document to a small laboratory printer, or to a network printer, we would recognize there is a connectivity problem, and that we could not transfer the data correctly. As a result, we show a warning and utilize temporary data storage on the balance to back up the results. When this happens, you will see some information in the data center and be given the option to transfer the data to a search location. That means you can define another server to send the data. If you have no possible locations, you can transfer the data to a USB stick instead or use an automatic background synchronization. That means every two hours, the balance tries to resend the data to the software system. 

Q: Is the printing technology thermal transfer accepted by the FDA?

SW: Yes, this is accepted. Thermal transfer is a very good printing technique because we have very long-lasting prints. Therefore, we can deliver a certificate for our printouts that are readable for more than 20 years. Besides the certificate, thermal transfer printouts are very accurate, giving a very good image, which in turn means very good readability. 

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