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technologies, such as the Paperwork Elimination Act of 1999 and 21 CFR Part 11, many companies continue to suffer from outdated procedures.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.
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:
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.
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 And it allows for routine reports to be created accurately and efficiently without error propagation from outdated practices.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.
Tyson Mew, president of Ofni Systems will be at the 20th Annual ISPE CASA Life Sciences Technology show at the Raleigh Convention Center in Raleigh, NC on Tuesday, March 26, 2013. Ty will be demonstrating how FastVal can reduce the time your organization requires to do validation projects by up to 70%.
ISPE Carolina-South Atlantic Chapter is a not-for-profit volunteer society of technical professionals who apply their practical knowledge in the regulated pharmaceutical and medical device manufacturing industries. ISPE is committed to the advancement of the educational and technical efficiency of its nearly 1300 members through forums for the exchange of ideas and practical experience.
Ty Mew and Ofni Systems will be available throughout the conference to discuss validation, demonstrate their validation automation tools and accept resumes from validation professionals.
Registration information for the 20th Annual ISPE CASA Life Sciences Technology show is available.
At Ofni Systems, we use FastVal to execute protocols electronically. Testers read the procedure and compare the actual result to the expected result. Users document results with screen shots that are automatically embedded into the executed protocol. If actual results do not match expected results, a deviation is automatically triggered. FastVal is a validated 21 CFR Part 11 compliant system. Testers are required to enter a valid User ID and password before accessing the protocol. All data entry is recorded in compliance with 21 CFR 11, and the audit trail is provided to clients along with other products of validation. The audit trail and security features provide additional information and increased data integrity over paper-based validation documents.
Recently, Ofni Systems was hired to perform an onsite validation of our ExcelSafe product. The ExcelSafe validation package is a 1200-step protocol which usually takes us four person-days to execute electronically with FastVal. This particular client requested that we perform the validation on paper as a case study to demonstrate the increased value of electronic protocol execution. There were numerous places where paper-based execution meant that the validation took longer or recorded less information than our standard electronic protocol execution method:
The paper based execution took a total of 10 person-days, two and a half times longer, to execute the protocol and generate the validation summary report (as opposed to 4 person-days when we use FastVal) and recorded less accurate, complete and legible information. The final result was a thick binder of paper that had to be scanned back into a document control system, as opposed to a collection of electronic files and PDF outputs that was already prepared for the client’s document control process. The paper based execution resulted in more time required to complete the project and a significant additional expense to the client.
Ofni Systems, a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies announces the release of FastVal Validation Document Generator v3.0. FastVal allows users to complete validation projects in 70% less time than using traditional validation methods. FastVal is compliant with all FDA/EU rules for electronic records and signatures, including 21 CFR 11 and Annex 11 and implements industry recognized best practices for validation, including GAMP 5. This release enhances FastVal’s ability to help enable organizations execute all aspects of their validation projects with shorter timelines and increased quality.
These enhancements increase FastVal’s ease of use and allow users to shorten the validation cycle while increasing the quality of the finished validation project. Managers have greater visibility into the status of validation projects and can have confidence that their validated system will withstand regulatory scrutiny. “Validation should add value to a computer system,” said Ofni Systems Validation Manager Ofni Systems. “FastVal produces higher quality documentation, in far less time, which in turn allows us to spend our time testing software, rather than generating documentation. FastVal can be customized to any customer validation requirements, which allows us to meet and exceed all of our customer’s standards.”
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