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technologies, such as the Paperwork Elimination Act of 1999 and 21 CFR Part 11, many companies continue to suffer from outdated procedures.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 And it allows for routine reports to be created accurately and efficiently without error propagation from outdated practices.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.

20th Annual ISPE CASA Life Sciences Technology Show

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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.

Validation Case Study: Electronic Protocol Execution vs. Paper-Based Execution

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filesAt 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:

  • Handwritten Dates have less information than Automatic Date/Time Collection: FastVal automatically attaches the system date/time to the test step after execution. This reduces the error rate in recording dates to zero, and provides more information by including the system time.
  • Corrections do not clearly demonstrate when the changes were performed: The standard practice for making a correction on a paper protocol is to line through, initial the change and make the correction with the appropriate date. While changes are marked sequentially on a page, there is no documentation of order of changes with the same change date. With FastVal, all of these changes are automatically documented into the audit trail, making it extremely transparent when changes occurred.
  • Screenshots had to be printed, gathered from the printer, then manually sorted and signed/dated: This was particularly difficult issue because our printer was several rooms away from the testers. FastVal embeds screenshots in the IOQ and automatically attaches the username, system date/time, and computer name to the image. With FastVal, the tester only needs to take the screenshot before proceeding with protocol execution. When paper execution required taking a screen shot, the user took the screen shot, walked down the hall to collect the printout, signed, dated and noted the correct test case step on the printout, then ensured that the piece of paper was physically placed in the correct section of the executed paper protocol. Because recording screen shots became so time intensive, paper execution tended to record fewer pictures and less information was recorded into the protocol.
  • Deviations had to be completed manually: As always, there were a few minor testing nonconformances (one planned deviation, plus a few tester glitches) during the execution. With the paper execution, deviations had to be filled in by hand. There will also be future costs to ensure that the deviation is mapped to the correct test case and step. In FastVal, once deviations are classified, the default text is populated from a  template, which reduces the amount of time required to complete the documentation of the deviation. This also provides a standard approach to completing all deviations which increases control over the deviation resolution process. Deviations are also linked to their test case and step.
  • Typing is faster than writing legibly: By entering information into the keyboard, there was no question about protocol legibility. The same cannot be said for handwritten documents at the end of a long day of completing protocols.
  • No automatic generation of validation metrics, reports or summary reports: FastVal automatically generates metrics recording the amount of time required to complete validation testing, including providing accurate reports on estimated time of completion and who executed what parts of the protocol. FastVal also automatically creates the Validation Summary Report; we had to spend a day writing the Summary Report from scratch.

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.

FastVal Press Release

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.

  • Creates All Required Validation Documentation – FastVal can generate any document your validation process requires. Many validation deliverables, included Requirement Traceability MatricesDeviation ReportsSummary Reports and Change Control Reports can be created automatically through internal wizards. FastVal includes templates provided by Ofni Systems, or can be modified to use your organizations existing templates. All documents can be generated as Microsoft Word or PDF files.Key Features of the FastVal Document Generator include:
  • Electronic Protocol Execution – FastVal allows users to execute test protocols electronically. Evidence of protocol execution is supported through text and screen capture. Electronic protocol execution uses electronic signatures to verify the identity of testers. Complete 21 CFR 11 audit trails document the protocol execution.
  • Automatic Deviation Tracking – Deviations are created automatically when actual testing results do no match expected results. Deviations and be resolved internally within FastVal, or exported to your deviation tracking tool for resolution.
  • Validation Project Management Tools – PStakeholders can see document and protocol status, follow deviations to resolution, and calculate validation metrics (including tracking requirement completion).
  • Updated Test Protocol Creation Tools – The Microtest Writer provides templates for commonly used functionality. This allows for quick creation of test cases by providing an interface to replace specific variables which are then automatically integrated and used to populate the test scripts. Highlights of this release include:
  • Updated Risk Assessment Tools – Responding to increased regulatory requirements in Annex 11 and FDA best practices, FastVal has an upgraded interface for documenting risk associated with validateable objects. Users document the risk associated with requirements and export the risk to either a Risk Assessment document or report.
  • Requirements Burn-Down List – InteIntegrates the test writing function with the functional requirements and the Traceability Matrix providing visibility into which requirements have not been covered by corresponding test cases. Automatically links test cases to the functional requirements and system design specification to automatically create the customized trace matrix.
  • Updated Metrics Reporting – The system provides complete transparency into the status of your project. The review status of all documentation can be viewed including the status of test case execution. The system contains integrated deviation reports and provides estimates of expected test execution completion based on current progress.
  • Enhanced User Interface – The FastVal user interface has been harmonized and improved to facilitate new user training and program ease of use.

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.”

Media Contact
Ty Mew
Ofni Systems, Inc.
Phone: (919) 844 – 2494

About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit

Warning Letter: Failure to validate software (ucm309410)

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  • Failure to validate the design under actual or simulated use conditions, as required by 21 CFR 820.30(g).
  • Failure to adequately document design inputs, as required by 21 CFR 820.30(c).
  • Failure to adequately document design outputs, as required by 21 CFR 820.30(d).
  • Failure to document process validation activities, as required by 21 CFR 820.75(a).
  • Failure to validate software used as part of production for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
  • Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
  • Failure to adequately establish procedures for corrective and preventive action; as required by 21 CFR 820.100(a).
  • Failure to adequately establish document control procedures, as required by 21 CFR 820.40. For example, your firm’s document control procedures, QOP-42-01) Control of Documents, Rev. D do not address how to control or identify [redacted]used to download the software in finished devices. These procedures do not have signature requirements that demonstrate documents, such as device history record documents· and design drawings have been approved. The documents are dated, and include the name of the individual approving the documents, but lack a signature. The software used to store the procedures, records and drawings do not have an electronic signature capability.

View the original warning letter.