21 CFR 11

Improved Reporting Efficiency with FastVal

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Document it. Write it down. Record it or it didn’t happen. The mantra of regulated industry. In pharmaceuticals, every action has potential health outcomes for real patients. Despite regulatory promotion of modern technologies, such as the Paperwork Elimination Act of 1999 and 21 CFR Part 11, many companies continue to suffer from outdated procedures. Quality documentation, however, need not hinder efficiency. Many pitfalls of traditional documentation practices can be avoided using simple, efficient tools.

Pitfalls in Standard Reporting Practices

Reporting departments, particularly, stand to benefit from abandoning stagnant practices. Generally, documents are built using approved templates or, less ideally, modeled on previous reports. Reporting staff assemble and format data, summarize procedures and deviations, and adjust layout to make everything fit. Each report is created anew for each project phase, with the only links between documents being the project name or a network folder. This approach, albeit common, presents a number of pitfalls. Manual data entry, on-the-fly formatting, and copy-and-pasting results into poorly-maintained templates lead to:

  • Repeat work
  • Errors and omissions
  • Avoidable revisions
  • Non-standard, confusing language
  • Template and style drift
  • Review errors

These reporting risks translate into delays. Striking balance between process improvement and production is tricky. The tendency is to forget about process improvement and focus on the mounting report backlog. Without addressing the central problems, producing reports becomes a matter of reinventing the wheel time and again.

An Updated Approach

Ofni Systems FastVal software is a compliant way to realize higher efficiency in documentation and to maintain control over the process. FastVal users are able to produce reports in up to 70% less time than conventional methods. FastVal mitigates risk in validation and reporting through a number of features: use of controlled templates, clear linkages between documents, single-point entry of replaceable terms, audit trails, change control, and electronic security. FastVal allows for enforced step-by-step review sign-off, promoting complete, thorough QC and QA checks for each project. And it allows for routine reports to be created accurately and efficiently without error propagation from outdated practices. The common elements of quality documentation are housed in one framework, bringing control, flexibility, and risk management to the reporting process.
Good documentation doesn’t just reinforce the scientific validity of results; it provides waypoints that allow for informed process improvement, deviation handling, and identifying training needs. It is the medium of Quality Systems, providing the framework for combining good business, advanced technology, and good science. And its evolution is a necessary component of providing the world with safe, effective, and valuable treatments and therapies.
Let us help you streamline production and remove the reporting bottleneck. Contact Ofni Systems for a FastVal software demonstration or with any questions you may have.

CDR Increasing Emphasizing on 21 CFR 11

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The FDA Center for Drug Evaluation and Research (CDER) is informing members of the pharmaceutical industry that its inspectors will increase enforcement of 21 CFR 11. Specifically, CDER will begin an inspection assignment of 21 CFR 11 requirements. This effort is part of CDER’s effort to evaluate industry compliance with 21 CFR 11. If inspections include observations that computer systems are not in compliance with 21 CFR 11, CDER intends on taking appropriate action to enforce Part 11 requirements. The timeframe for this CDER initiative has not yet been determined, but CDER wants the inspections implemented and completed soon.When distributing this information to members of the pharmaceutical industry, the key point was “Industry has had since August of 2003 to understand how we intend to enforce Part 11 as per the guidance and be in compliance. Therefore, the intention of CDER to take appropriate enforcement action should not be a surprise.”

21 CFR Part 11 sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.At this point, other FDA centers are not involved, but they have been informed of the CDER initiative and will be monitoring CDER findings.