 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
In this Edition
Featured Article I Upcoming Events I Customer Spotlight I Recent News I Employee Spotlight I Technology Tip I Client Support I Just for Fun
Managing strict compliance requirements for experimental studies is a difficult task that requires dedicated staff, sound management practices and attention to detail in an environment fraught with regulatory requirements, multi-site studies and inter-institutional collaborations. Faced with high volumes of disparate data, compliance managers need to rethink ways to efficiently and effectively manage compliance requirements. Best Practices in Multi-Site Compliance Management While multi-site compliance management may seem overwhelming at first, there are steps organizations can take to simplify compliance management and ensure continued compliance. Discussed in this article are a few proven best practices to help an organization successfully manage compliance across multiple locations: Centralize Data Management First and foremost, multi-site compliance managers need a 360 degree view of all compliance-related operations and access to critical research information including: study protocols, committee review information, research subject metrics, and review/renewal/approval dates and deadlines. By collecting each site’s siloed information in one central location, institutions can efficiently store, update and track their research activities. This centralized data increases management’s awareness of research activities while reducing the potential for administrative noncompliance. Standardize Data Captured Across Sites and Studies While centralizing disparate location data is important, it can be difficult to maintain without standardization. To help standardize data and maintain consistency across locations institutions must create and leverage standardized templates. To accomplish this, first define key data components required across every study at every site (e.g., regulatory-mandated information) and then define site/study specific requirements. As templates are defined, seek multi-site feedback and actively consult with study management to ensure necessary data is captured. Developing these standardized templates will help drive global initiatives, manage end-user expectations and gain site buy-in; reducing resistance to change and ensuring new operational expectations are met. In addition to uniform metrics, institutions must allow appropriate site-specific processes to remain intact to ensure relevant processes are maintained. Finding the right blend of standards, harmonization and location-specific processes is key to the success of multi-site data management. Automate Compliance Management One of the largest challenges for managing compliance across multiple locations is keeping up with the overwhelming amount of data and making sure important deadlines are met. By automating operations, institutions can leverage automated alerts to ensure research needs are being met while maintaining study time lines and ensuring all requirements are in place to keep the organization operating in compliance. Automatically tracking key expiration dates, deadlines and usage information virtually eliminates human error, providing valuable assistance in removing potential non-compliance weak points. Monitor Activities Frequently for Each Site To ensure compliance requirements are being followed at every location, it is important to implement a consistent reporting regimen to closely monitor the day-to-day activities. In addition to reviewing reports on a regular basis, compliance managers should maintain detailed audit trails of every study, for both regulatory and internal tracking needs. Appoint An On-site Compliance Specialist For Each Location While it is important to have a central compliance manager that overseas institutional compliance procedures, it is equally important to have site-specific compliance specialists. A compliance specialist on location will have more hands-on contact with the site’s operating environment and the specifics of the study and will be more in-tune with compliance procedures. This onsite expertise and additional enforcement will provide an extra level of protection to help ensure compliance requirements are being met. Successfully Managing Multi-Site Compliance As the biomedical research industry continues to change and the regulatory burden continues to increase, it is important that institutions have an efficient process in place to maintain compliance across the organization. The growing pains of multi-site compliance management can be minimized by following the best practices mentioned in this article. Following these will not only simplify compliance management and protect your organization; it will provide a scalable environment and structure for future growth. Upcoming Events TOPAZ Technologies International Conference When: August 29 – September 4 Live Webcast: Effective Approaches to Maintaining Federal Compliance for Research Protocols Date: Tuesday, July 28, 2009
Customer Overview:
Recent News TOPAZ Technologies Introduces Biosafety Software Solution Solution Automates IBC Protocol Operations and Addresses Research Compliance Requirements TOPAZ Technologies recently introduced the latest software addition to its product line, the Biosafety Solution. Our new software is a web application that automates the protocol process from inception to approval. Like our other software, the Biosafety application helps prevent regulatory compliance violations by compiling, tracking, and managing complex research data while creating audit trails and comprehensive reports on demand.
Employee Spotlight Willkommen (Welcome) Dr. Gabriel N. Schenker TOPAZ welcomes the newest member of our team, Gabriel N. Schenker, Ph.D. as Senior Software Architect.
Technology Tip GRANITE™ Training Module Helps Regulate Compliance Requirements Tracking employees’ qualifications manually can be time intensive and risky when trying to achieve compliance. Did you know that GRANITE can help with that? Its training module can simplify training and certification tracking to ensure staff qualifications are met and up-to-date.
With staff members directly linked to protocols, you can select any individual and gain full access to their training records, certifications, and expiration dates. Additionally, by using dynamic filtering, you can automatically identify qualified individuals for new or upcoming studies based on procedural qualification requirements. Simply enter a procedure or species and a qualified match is made. Moreover, by adding these features to the web based protocols software, you can access this information anywhere, at anytime, to ensure ongoing compliance. To learn more about the GRANITE Training Module, contact customer support or call 800.250.9090. Client Support The Wide World of Web Applications. Upgrade Your Software Today. Still using legacy software? Upgrade to our rich internet applications today.
Why wait? Schedule your upgrade today at 800.479.2498 Want more information on upgrading? Download our pdf. Just for Fun LAR and Order Comic Series Back by popular demand. The LAR and Order comic series is sure to put a smile on your face. Meet the Boss ... 
... and the Professor 
To be continued … Stay tuned. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 ©Copyright 2009. TOPAZ Technologies. All rights reserved.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
