FDA 21 CFR Part II

Title 21 Code of Federal Regulations (CFR Part II) ensures that stringent controls are in place over electronic data and signatures during those manufacturing processes regulated by the Food and Drug Administration. Affected organizations include pharmaceutical, biotechnology, medical products, cosmetics, food, beverage, and fine chemicals companies, along with their suppliers, across the globe.

The Business Challenge

The most challenging aspects facing organizations tackling 21 CFR Part II are:

The Safestone Solution

Safestone’s Security Manager is a modular and integrated approach that can help define, manage and report on security policy compliance enabling future audits to be passed simply, quickly and efficiently.

The timely delivery of critical data and information to end-users is a fundamental concept of the business. With Risk & Compliance Monitor organizations can immediately identify compliance vulnerabilities across System i and automatically run reports.

Ensuring that critical data sources held on the System i are treated confidentially is a key part of tackling 21 CFR Part II compliance. Without adequate controls, unauthorized staff may gain access to sensitive information and use it to their advantage. Network Traffic Controller ensures that only the right personnel can actually access and use specific data.

The integrity of an organization’s data is at the forefront of 21 CFR Part II compliance. Adequate controls need to be implemented on the System i to maintain the reliability of corporate data and to provide assurance that the data is trustworthy. Security Audit & Detection puts controls in place and prevents data being manipulated and corrupted.

Multiple Systems Administrator allows you to centralize administration of networked System i servers and partitions through a single point of control. Deployment and administration costs are significantly reduced, while resources are optimized and consistency is assured.

Controlling the user lifecycle can significantly enhance security and User Profile Manager provides flexibility to easily manage profiles and passwords across System i. In addition the inability of a user to perform their IT functions because of profile or password issues is a situation that must be avoided. Password Self Help enables users to reset their own passwords without the need to call the Help Desk.