Key Characteristics of FDA Part 11 Compliance

February 4th, 2016 by

Ultrasound Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, pharmaceutical companies and medical device manufacturers are increasingly using the Internet to broaden their services making compliance with FDA regulation even more important.

As a [...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory compliance is important for any life-sciences firm, but the breadth of your responsibilities won’t always be immediately clear. For instance, you may be well aware of the fact that 21 CFR Part 11 [...] Read More

What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the more complex computer systems employed by life-sciences firms are in some way customized. Even those who rely on vendor-assembled systems often find themselves having to tweak [...] Read More

How Can Your Firm Implement QSIT Principles?

August 25th, 2014 by
QSIT Principles

Are You Using QSIT Principles?

Today’s medical device manufacturers must be self critical as they implement their quality systems, but being impartial about oneself can be difficult. For instance, many companies are aware of the fact that their quality systems should [...] Read More

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

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

Medical Device Risk Management and ISO 14971

June 26th, 2014 by

ISO 14971ISO 14971 is one of the ISO standards that define the international requirements for medical device manufacturers by managing risk associated with the use of medical [...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

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.

While it would be nice to prevent such issues [...] Read More

Implementing Comprehensive Quality Systems For FDA Medical Device QSR And Other Regulations

May 12th, 2014 by

FDA QSR ComplianceThe FDA’s Quality System Regulation shouldn’t act as a hindrance to medical device manufacturers. While many companies are wary of falling afoul of the compliance guidelines contained in Title 21 CFR sections like Part 820, smart leaders realize that FDA QSR compliance can be a stepping [...] Read More

Using Software Validation Of IT Systems For FDA Compliance

April 16th, 2014 by

IT Software ValidationCompanies which must work in a GxP environment rely on a range of different technologies to maintain consistent quality and levels of output. In addition to the control software these organizations employ to manage their manufacturing and marketing operations, modern companies also use software designed to implement and maintain valid quality controls.

Naturally, such software must [...] Read More