Recent releases and updates of compliance products

VelQuest   

SmartShell from VelQuest is said to provide 21 CFR Part 11 remediation for PC-based instruments and desktops that may not, by themselves, comply with the Part 11 regulations. It also provides centralized security and access control administration for all laboratory instruments, and a centralized repository for all regulated data.  In addition, SmartShell software provides these same capabilities for Microsoft's Excel and Word applications. VelQuest released its current application library showing 45 applications that have already been used in conjunction with its SmartShell compliance management system.

Agilent Technologies

Agilent's new method validation pack version A.02.01 for its ChemStation Plus chromatography data system (CDS) is the first system of its kind to provide solution stability calculations for short- and long-term stability studies as defined by the International Conference for Harmonization (ICH). The software further offers major productivity improvements for validation planning, execution, and reporting. Read the press release.

Datastream Systems

Datastream 7i, an asset performance management solution, has enhanced its Web-based capabilities and added stronger regulatory compliance features, including the addition of the entire Calibration Module to Datastream 7i Extended and the ability to apply auditing rules to custom fields and comments. This facilitates compliance and reduces the risk of costly violations for customers in regulated industries, such as pharmaceutical, oil and gas, and nuclear power. Read the product announcement.

The FDA Will Mandate SPL Use in 2005
Learn More with this Free White Paper

By Joe Jenkins
Marketing Director for Life Sciences, Arbortext

In today's complex, global life sciences marketplace, the ability to manage product information is a daunting task. Many departments across the enterprise use the approved product information for a variety of purposes, including package and labeling, promotional materials, and product web sites. It is common practice for each department to take a copy of the approved content and re-create it for its own use, leading to significant process inefficiencies and potential for inconsistent product information.

Additionally, there are many consumers of this product information including regulatory authorities, academic research centers, health care professionals, and the general public. These people depend and rely on accurate and consistent information about drug products independent of the manner in which they access this information, whether through paper-based, electronic, or other channels.

The ability to ensure greater control over this critical product information has led to the development of a standard for product labeling. This standard, known as Structured Product Labeling (SPL), is being adopted by the FDA to assist in greater patient safety and increased usability of product information across its consumer base.

In 2005, the FDA will mandate the use of Extensible Markup Language (XML) that is compliant with the SPL standard for electronic submissions. Arbortext has developed a free white paper about SPL to help companies:

·        Develop a deeper understanding of SPL

·        Discuss the goals and benefits of SPL

·        Understand the impact that SPL will have on current labeling processes

·        Identify additional resources for broadening SPL knowledge

The white paper provides a comprehensive overview of SPL, covering both business and technical topics. As such, this document is appropriate for anyone that has responsibility for labeling content within pharmaceutical and biotechnology companies, or other firms impacted by the FDA Guidance on Labeling Content.

To download this free white paper, An Introduction to Structured Product Labeling, please visit http://www.arbortext.com/spl_whitepaper.