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Jennifer Markarian is manufacturing editor of BioPharm International.
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
Data integrity is important in the biopharmaceutical R&D laboratory as well as on the plant floor. Although many organizations still use paper-based processes in the laboratory, electronic systems can improve data integrity, says Laurence Painell, vice-president at IDBS, a provider of cloud-based R&D technology and solutions. Painell spoke with BioPharm International about ensuring data integrity in the laboratory using electronic systems.
BioPharm: What are the benefits of electronic data systems for improving data integrity?
Painell (IDBS): Electronic systems wrapped in good behavioral and procedural practices remove opportunities for individuals to make mistakes or to manipulate the data. Automation saves time, improves outcomes, and increases throughput, whilst removing errors. Electronic systems can also provide clear visual clues to users where a step has been missed or something is out of the expected bounds. By using validated templates, businesses can provide secure transparent links between raw data files and final calculations for ease of audit, and they can also apply consistent pre-established business rules that have been set and validated within the system. Lastly, ensuring the system supports quality-by-design and audit-by-exception guidelines further enables review and verification of information in real time and guarantees that the data can be accurately reconstructed months or years later.
BioPharm: What can companies do to improve data integrity when using electronic systems?
Painell (IDBS): Automate as much as possible, which could be transferring of data between systems or the removal of manual data entry. Ensure that your systems clearly track and audit everything done within them. Implement some form of master data management, which ensures that different systems have clearly defined naming conventions which link the data between the systems and remove ambiguity from the process.
BioPharm: How can manipulation of electronic records be detected and prevented?
Painell (IDBS): The use of audit logs that cover all data entry, calculations, and reporting will help prevent some of this risk. Doing this only at the record level is not enough though, a system needs to monitor and track changes at individual data-point level. Additionally, having a well-structured security model will also ensure that only those with the correct privileges will be able to edit the data in a given experiment; once this is in place, algorithms can be used to identify abnormal behavior and flag it to the system owner. Creating structured workflows and templates that allow all data to be captured correctly and automate calculation will also help protect electronic records. Lastly, ensuring that any data changes or updates are properly recorded, justified, and electronically signed will detect any potential manipulation.
Volume 30, Number 7
When referring to this article, please cite it as J.Markarian, “Laboratory Data Integrity Benefits from Electronic Systems," BioPharm International 30 (7) 2017.