Industry-focused Compliance - Governance, Risk, and Compliance Topic for Oracle Applications - page 376

You can instigate an engineering change or corrective action request to manage the
compliance risk with the Approved Manufacturer List on this part. Alternatively,
every time you create a new pending Rev , the system will calculate the compliance
impact of the change.
Life sciences and medical instrument
manufacturing
Next, we will leave the Infission corporation to talk to some colleagues who manage
manufacturing at a medical instruments company— Lilean Brosh . We will interview
them on what they consider to be their most urgent compliance issue. We will dive
into the details of CFR 21 , and show how the audit procedures of this standard
fit into GRC Manager. We will also show how some of the records management
requirement of CFR 21 Part 11 are managed through digital signature aspects of
Oracle Workflow.
Title 21: Code of Federal Regulations
This regulation relates to the Food and Drug Administration's primary jurisdiction
for the premarket review and regulation of products that comprises any combination
of a drug and a device; a device and a biological product; a biological product and
a drug; or a drug, a device, and a biological product. An example of a biological
product is a vaccine.
The thrust of CFR 21 is good manufacturing practices to protect human health. It
requires product sampling and testing, which proves that the manufacturing practice
is sufficiently good, and an electronic records protocol that brings about personal
accountability for signing those records.
There are many aspects of good manufacturing practices that support food and drug
manufacturers in Oracle E-Business Suite Process Manufacturing. They are as follows:
• Stability studies management : These studies characterize the effects of aging
on the quality and shelf life of a material
• Receiving holds : They help companies validate the quality of expired or
expiring material
• Quality controlled batch processing : This gives you a view of the grade and
quality of your on-hand materials before you begin production