Source: https://www.mastercontrol.com/gxp-lifeline/clinical_investigations_guidance_707/
Timestamp: 2019-05-26 23:06:48
Document Index: 612616490

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

In light of recent news that the release of a new 21 CFR Part 11 and companion guidance will be delayed until later this year or next year, the FDA released a supplemental guidance entitled Guidance for Industry: Computerized Systems Used in Clinical Investigations in an effort to ease current concerns and confusion.Under the guidance of the FDA, the Center for Drug Evaluation and Research (CDER) is scheduled to release around forty more guidances in the year 2007, six of which are directly tied to compliance and electronic systems. But, just how effective are these guidances in helping regulated companies further understand FDA regulations like 21 CFR Part 11?
A recent survey conducted by BIOCOM and PriceWaterhouseCoopers entitled “Improving America’s Health IV” reveals that communication between the industry and FDA has improved since the FDA Modernization Act of 1997. The survey also shows that while FDA staff turnover decreased product review time and communication between industry and Agency reviewers pointed to an increased need for funding, overall relations between FDA and the industry has improved and is improving. 73% of respondents to the survey—which included pharmaceutical, biopharmaceutical and medical device companies—said that FDA guidance has had a positive impact on the development process by giving them a better understanding of requirements. And, despite confusion over 21 CFR Part 11, half of all respondents said that FDA guidance on data standards has helped them better automate internal processes.In response to the surveys, BIOCOM CEO Joe Panetta said, “The issue of guidance is critical. Results show that we need to understand the importance of communicating regularly with the FDA, follow guidances, and question them actively to ensure that they have been properly understood.”
In an industry that is increasingly dependent on both speed and safety for the development and production of drugs, there is no doubt that computerized systems help regulated companies decrease the inefficiencies that plague outdated paper-based systems. Automated software solutions increase visibility, accuracy, and timeliness throughout the product development cycle.With more pharmaceutical companies turning to computerized management systems, the Guidance for Industry: Computerized Systems Used in Clinical Investigations, which was released May of this year, is clearly a step towards further clarification of FDA regulatory compliance expectations. The new guidance for handling clinical investigations with an electronic system includes the quality and integrity of all electronic records involved in study protocols, SOPs, documentation, retention, and security safeguards.
These clarified expectations on SOPs will be embraced by pharmaceutical companies looking for more direction as to just how 21 CFR Part 11 is to be interpreted and enforced during inspections and audits.With the guidance Computerized Systems Used in Clinical Investigations, the FDA acknowledges just how important regular communication is within the industry in relation to the clarity and consistency of enforcement. The new guidance allows regulated pharmaceutical companies see the FDA’s recommendations regarding the use of computerized systems. While there will not be a complete revamping of 21 CFR Part 11 any time soon, the FDA moves to further clarify the expectations of 21 CFR Part 11 with this clinical investigation guidance and future guidances.