For Pharmaceuticals:

A New Clinical Guidance: Clarifying or Confusing

Discusses how the FDA?s new clinical investigations guidance will positively affect pharmaceutical companies in light of recent news on the relationship between FDA and the industry

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?

An Update: The Current State of Relations Between the FDA and the Industry
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 companiessaid 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.”

About the New Clinical Investigations Guidance
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of drugs, there is no doubt that computerized systems help regulated companies decrease the inefficiencies that plague outdated paper-based systems.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.

This guidance includes a unique recommendation on the scope of SOPs that should be developed for an electronic system. In Appendix A, the FDA states that SOPs should include, but are not limited to, all the following:

  • System setup/installation (including the description and specific use of software, hardware, and physical environment and the relationship)
  • System operating manual
  • Validation and functionality testing
  • Data collection and handling (including data archiving, audit trails, and risk assessment)
  • System maintenance (including system decommissioning)
  • System security measures
  • Change control
  • Data backup, recovery, and contingency plans
  • Alternative recording methods (in the case of system unavailability)
  • Computer user training
  • Roles and responsibilities of sponsors, clinical sites and other parties with respect to the use of computerized systems in the clinical trials

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.

Read more about electronic management software solutions::

White Paper:

21 CFR Part 11 Industry Overview - Be Ready for an FDA inspection

White Paper:

Quality Audit – A Tool for Continuous Improvement and Compliance

Click here to view all available resources.

If you are a current MasterControl customer click here to download documents directly through our Customer Center.


FDA Link

  • Guidance for Industry: Computerized Systems Used in Clinical Investigations

Additional Article