Meeting standards is easy. Going above and beyond is what sets Oliver apart.
The best systems are those derived from a continuous improvement program. Whether it’s meeting the strictest ISO standards and FDA regulations, implementing vision inspection technology, or investing in our facilities, we relentlessly seek new ways to improve. We are further developing all aspects of our operation model.
All sites are ISO 13485 certified
Annual cGMP Training for all employees
Statistical Sampling (ASQ/ANSI Z-1.4, Z-1.9 and C = 0) Z-1.4, Z-1.9 and C = 0)
Robust Validations IQ, OQ, PQ for ISO 11607 Part 1 and 2
Independently ISO 14644-1 certified cleanrooms
21 CFR Part 11 document management system
In October 2014, the FDA issued draft guidance in response to Title II (a/k/a the DSCSA) of the Drug Quality and Security Act (DQSA) of 2013. The requirements and compliance deadlines...
It is no secret that heat sealing has been a perennial mainstay in the process of medical device and pharmaceutical product development. Rapid technology advancements are...