White Paper

Computerized System Audits in a GCP Pharmaceutical Laboratory Environment | IVT

Computerized System Audits in a GCP Pharmaceutical Laboratory Environment
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.

Download "Computerized System Audits in a GCP Pharmaceutical Laboratory Environment"

Also See:




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.

Comments (0)

Post new comment

The content of this field is kept private and will not be shown publicly.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
  • Use to create page breaks.
Image CAPTCHA
Enter the characters shown in the image.

CHROMacademy Video Training Courses