Auditor Verifies Overture EDC is 21 CFR Part 11 Validation Ready

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Forte Research Systems announced Overture EDC passed a third-party audit without any deficiencies to meet requirements be 21 CFR Part 11 validatable.

Overture EDC from Forte Research Systems

After substantial dedication to offer software that meets regulatory requirements, Overture EDC, the electronic data capture software from Forte Research Systems, Inc., has been confirmed to be 21 CFR Part 11 validation ready. An external auditor conducted a series of assessments to determine that the system has all of the technical controls in place that are necessary to comply with government regulations and provide reliable data security.

Commitment to Customers

Forte invested considerable resources to be able to offer a product that is 21 CFR Part 11 validation ready to the life science industry. Education and preparation started in early 2012. The decision to meet compliance requirements stems from Forte’s dedication to providing customers with the highest level of quality in products and responding to their evolving needs. Colleen Krattiger, Vice President of Quality and Regulatory Affairs at Forte, led this initiative, which impacted the entire company. Krattiger said, “The Forte team has demonstrated a high level of organizational maturity to bring this 21 CFR Part 11 product to our customers.”

Journey to Compliance

Industry expert Robert Finamore, Director of IT and Compliance at QPharma, Inc., conducted the third-party audit. In April 2013, an initial assessment evaluated Forte's existing processes and the Overture EDC development plans. Finamore provided feedback regarding 21 CFR Part 11 product and process gaps. As a result of this assessment, Forte established a Quality Management System (QMS) based on the ISO-9001 standard. The guiding principle of the QMS is to continually address customer needs and maintain outstanding quality as the system evolves. As a result, Forte adapted their existing processes to comply with 21 CFR Part 11 requirements.

Follow-up assessments occurred in September and November 2013, in which Finamore reviewed the QMS and the application development progress. Based on these assessments, Finamore stated, "It is the conclusion of the auditor that the system has sufficient technical controls in place such that it can be implemented in a Part 11-compliant fashion, assuming deployment of additional, necessary customer documentation and controls."

When it comes to 21 CFR Part 11 compliance, the customer and software provider have a relationship in which they each need to do their part to validate a system. There are several process implications for which the customer bears the burden of proof for validation. On the other side, the software provider fulfills the product technical controls. Overture met the Part 11 technical requirements, and Forte has many well-defined processes and documented evidence that they follow these processes to fulfill the requirements laid out by the guidance.

Overture was developed to offer the right balance of sophistication, ease-of-use, and affordability. Srini Kalluri, President, CEO and Chief Customer Officer at Forte Research Systems, said, “Historically, the cost and complexity involved with many of the existing EDC systems have resulted in a lack of adoption for early stage and shorter duration trials. By combining a great ease of use and rapid study set-up functionality, Overture EDC extends a cost effective solution for these trials.”

To learn more about Overture EDC visit or attend an open demo.

About Forte Research Systems, Inc.

Founded in 2000 and headquartered in Madison, Wisconsin, Forte creates software and provides resources for better research compliance, patient safety, operational efficiency, and financial viability. Products include OnCore Enterprise Research, Allegro CTMS, and Overture EDC. Forte also hosts the Clinical Research Blog and the Research Resonance Network for sites and clinical research professionals pursuing excellence in clinical research operations.

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Kristina Lopienski
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