Computers and computerized systems are an integral part of daily life in the laboratory. Examples include: laboratory equipment, Laboratory Management Information System (LIMS), the network, servers, databases, and individual workstations, all providing remote access to important data. Government rules, regulations and guidance documents contain specific requirements for computerized systems. One of those regulations is Good Clinical Practice (GCP). As quoted from the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice:
“GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”
The key point to remember is that clinical laboratories process and manage patient data, and this data is used to make critical medical decisions. If the data a laboratory produces is incorrect, decisions taken may be incorrect, and this could mean:
- Patients may be harmed
- Submissions may be delayed or turned down
- Inaccurate information may be included on the product label.