News
Prodiance Announces Spreadsheet Control Solution for Pharmeceutical & Biotech to Improve 21 CFR Part 11 Compliance
San Ramon, Calif. – June 3, 2009 – Prodiance Corporation, a leading global provider of Governance, Risk and Compliance solutions, today announced a Spreadsheet Control solution for pharmaceutical and biotech organizations to enable compliance with the FDA’s 21 CFR Part 11 and EU Annex 11 mandates for electronic records.
"Analytical spreadsheets are used extensively in drug discovery and development processes," said Eric Perry, vice president of marketing at Prodiance. "Their inherent flexibility can lead to errors, unauthorized changes, non-compliance, and fraud when critical spreadsheets are not properly managed."
Under 21 CFR Part 11, spreadsheets included in electronic submissions must comply with FDA requirements, including strict security and access control, data integrity, data accuracy, confidentiality, authenticity, electronic signatures, and validation. In the EU, Annex 11 imposes a set of similar compliance requirements.
"Out-of-the-box, Microsoft Excel has not been designed for compliance, and special steps must be taken to ensure the proper controls are in place to meet FDA 21 CFR Part 11 mandates," said compliance and validation expert Dr. Ludwig Huber. "Best practices for spreadsheet control to enable compliance include establishing a corporate spreadsheet control policy, designing for compliance, validation, and leveraging spreadsheet control software to automate the controls environment. To this end, Prodiance technology address the key controls to enable 21 CFR part 11 compliance while simplifying validation and testing efforts."
Prodiance ESM for 21 CFR Part 11 Compliance
The Prodiance Enterprise Spreadsheet Manager system is a comprehensive and integrated suite of products designed to help pharmaceutical and biotech organizations automate internal controls over key spreadsheets, Access databases and other end-user computing (EUC) applications that are in scope for 21 CFR Part 11 compliance. The system incorporates industry proven capabilities for discovery, inventory management, risk assessment, management and control, optimization, certification and management reporting. A new digital signature module for Microsoft Office SharePoint Server 2007 (MOSS) has been added to specifically address the compliance needs of the pharmaceutical and biotech industries.
More Information
The Prodiance ESM solution for 21 CFR Part 11 compliance is shipping and available for deployment immediately to customers. More information about the solution is available on the Prodiance web site or by downloading the new white paper entitled Automating Spreadsheet Controls for 21 CFR Part 11 Compliance.
About Prodiance
Prodiance delivers Governance, Risk and Compliance (GRC) solutions to help increase visibility, transparency and control over End User Computing applications such as spreadsheets, databases and BI reports which comprise a significant portion of mission critical data within organizations. Prodiance leverages over 18 years experience in delivering innovative technology solutions for highly regulated markets. Leading global organizations across the banking, insurance, capital markets, energy, telecommunications, manufacturing, media and entertainment, food and beverage, health care, and educational markets have trusted Prodiance as a strategic partner to achieve their goals. Prodiance Corporation is an independent, privately held company based in San Ramon, California. Additional news and information about Prodiance solutions, products and services is available at www.prodiance.com or by calling 1-866-569-5678.
Prodiance PR Contact:
Eric Perry
Vice President, Marketing
Tel: +1-866-569-5678
Email: eric.perry@prodiance.com
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