News » Compliance-consulting
Browse All Categories
James Francum
By James Francum on June 11, 2021

The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that apply to finished devices, that are intended for human use. Rather than impose strict requirements, the regulations offer an opportunity to the manufacturers of these devices to incorporate their quality management standards into key organizational processes.

By Henry Macartney
on June 23, 2020

Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you're good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it's time for a serious change.

Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on June 12, 2020

Data integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

By Henry Macartney
on June 02, 2014

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

James Francum
By James Francum
on March 12, 2014

Pharmaceutical Production ComplianceThe most succinct answer to the question of what determines FDA compliance with GMP regulations of pharmaceutical production is adherence to 21 CFR Part 210 and 211. Anything less than complete adherence will render products as “adulterated” in the eyes of the FDA. Failure to comply could lead to disruptive regulatory action against a company.