Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?

July 29th, 2014 by

Electronic RecordsFDA 21 CFR Part 11 isn’t as broad as some regulations. Nonetheless, it’s complex enough that comprehensive compliance systems can offer a great deal to those who want to stay ahead of the game.

Many [...] Read More

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by

Quality Risk ManagementRegulatory compliance can be tricky, especially when it comes to your overarching quality management services. There are many guidelines, regulations and laws to understand in order to be compliant in [...] Read More

Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by

ICH Q9 Risk ManagementAs you make efforts to adhere to guidelines and regulations created by diverse international bodies, you may find your firm pursuing numerous paths to compliance simultaneously. While there’s nothing wrong with taking specific approaches to each relevant quality [...] Read More

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by

Quality By DesignPharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful [...] Read More

What Makes a Quality Management System Effective?

July 11th, 2014 by

Quality Management SystemModern quality management systems are often called upon to help their users meet varied regulatory standards and guidelines. For instance, your company may employ a single gap-analysis scheme to prepare your production lines for FDA and ISO audits and alike and simply plug in [...] Read More

Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by

FDA 21 CFR Part 11The FDA requires medical device manufacturers, pharmaceuticals manufacturers, biotech companies, biologic developers, and other FDA-regulated industries to comply with their regulations and implement controls.

These controls should also [...] Read More