Improving CAPA in the Regulated Industries

May 29th, 2014 by

CAPA SystemCorrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action to eliminate the cause of a detected nonconformity, or any other situation deemed to have adverse effects on a drug product. A preventive action (PA) is an action to eliminate the [...] Read More

Preparing A Superior Audit Checklist With FDA 21 CFR 210

May 27th, 2014 by

21 CFR 210 Compliance Road MapIt’s hard to navigate in the dark, and although FDA regulations can seem blindingly overwhelming, smart pharmaceutical manufacturers actually use them to clarify [...] Read More

Quality Management Steps of Risk Assessment

May 22nd, 2014 by

CAPA Risk ManagementQuality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be [...] Read More

Improve Record Keeping With 21 CFR Part 11

May 20th, 2014 by

Electronic SignatureElectronic record keeping is an essential yet complex part of running a life sciences firm. Modern software tools afford medical device manufacturers numerous methods for digitally tracking lots, batches and supply chain [...] Read More

Are You Up To Speed On The FDA’s New Regulation On Supply Chain Integrity

May 16th, 2014 by

FDA Supply Chain IntegrityThe Division of the Supply Chain Integrity of the FDA has two main goals, which are:

  1. Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers.
  2. Raising public awareness of drug security threats and vulnerabilities in the supply chain.

These goals stem from the Drug Supply Chain Security Act (DSCSA) Title II of the Drug Quality and Security Act of 2013 in which the following [...] 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

GxP-CC Earns ISO 9001:2008 Certification

May 8th, 2014 by

ISO 9001:2008 Certified IQNetGxP-CC has achieved ISO 9001:2008 certification. Developed by the International Organization for Standardization, ISO 9001:2008 is recognized as the worldwide standard for [...] Read More

Staying Up-To-Date With FDA Pharmaceutical cGMPs

May 5th, 2014 by

Pharmaceutical cGMPYour firm’s pharmaceutical products aren’t the only things subject to U.S. and international regulations. For decades, agencies like the FDA have also required manufacturers to adhere to a range of best practices that include management of production facilities and supply chains.

The Current Good Manufacturing Practices, or cGMPs, include a number of regulations and recommendations designed to help firms protect public safety. Learning which of these guidelines apply to [...] Read More