France's Data Protection Authority, the Commission Nationale de l’Informatique et des Libertés (CNIL) announced on September 23, 2011 that it had found the French provider of universal telephone directory services, “Pages Jaunes,” guilty of violating several provisions of the French data protection law. The CNIL did not fine Pages Jaunes, but published a detailed warning, listing each privacy violation that the CNIL had identified during its investigation of Pages Jaunes’s activities. 

At issue was Pages Jaunes’s web crawler function, which Pages Jaunes has discontinued. The crawler captured information contained in Facebook, Twitter and LinkedIn profiles of persons having the same name as the person being looked up in the directory service. For example, if someone were to look up the telephone number of Pierre Dupont. Pages Jaunes would show Mr. Dupont’s phone number, and would also show information on social media sites relating to persons named Pierre Dupont. The information may include photos, the name of Dupont’s employer, the schools he attended, his geographic location, his profession, etc.

Pages Jaunes argued that the persons whose profiles were copied had been duly informed and consented, because the general terms and conditions of the social media sites indicate that information posted on public profiles may be accessible to search engines. 

The CNIL dismissed this argument. First, a number of the profiles that were being accessed were profiles of minors, and the informed consent of minors for this type of activity cannot be deemed to exist in these circumstances. Second, the reference to “search engines” in the social media sites’ general terms and conditions cannot be deemed to extend to companies whose principal activities are not that of a search engine. The CNIL pointed out that Pages Jaunes is a telephone directory and not a search engine. According to the CNIL, if the terms of use of the social media sites expressly mentioned that data in public profiles could be re-used by Pages Jaunes, that might constitute sufficient information and consent to allow Pages Jaunes to extract data from those sites. The CNIL pointed out that Pages Jaunes had entered into an agreement with one social media site called Trombi pursuant to which Trombi expressly mentioned on its site that data could be accessed and used by Pages Jaunes. For the major social media sites, however, no such agreement with Pages Jaunes existed. 

The CNIL also found that Pages Jaunes had breached its obligation to ensure that only accurate and updated data are processed. According to the CNIL, the profile data that was presented by Pages Jaunes was in many cases outdated by 4 to 12 months.

Pages Jaunes argued that it provided data subjects with the ability, on the Pages Jaunes website, to ask that their profile data not be accessed by Pages Jaunes, but the CNIL found that the procedures put in place by Pages Jaunes were too burdensome. A person must fill out a form and submit to Pages Jaunes proof of his or her identity for each social media site that the person wants to block. The CNIL also criticized Pages Jaunes for keeping logs of IP addresses and the time and date of queries made on the Pages Jaunes site. According to the CNIL, the retention of these data is excessive and not required under French law because Pages Jaunes is neither a telecommunications operator nor a hosting provider. Finally, the CNIL found that Pages Jaunes had violated its obligations with respect to the telephone directory data that it processes, because Pages Jaunes used that data to help refine the results of the social media profile searches. Under French law, universal directory providers are prohibited from using telephone directory data for any purpose other than providing a universal directory service. Pages Jaunes’s use of these data exceeded the scope permitted under French law.

The CNIL’s decision is a useful analysis of issues that are arising when collecting data publicly available on social media sites.

At the Summit, industry experts will take an in-depth look into how the latest technologies are being used today to solve critical business issues within the Life Sciences industry.

The event will include a continental breakfast for all attendees followed by opening remarks and three breakout sessions.

• Electronic Trial Master File: The session will focus on leveraging intelligent capture to automate the way documents and data are captured globally in an eTMF.
• Safety Reporting: Leverage intelligent document capture to improve pharmacovigilance and integrate with leading safety systems.
• Records Management: Leveraging technology to maintain critical electronic and paper based information. See how actual retention policies and procedures combine with technology to reduce the cost and risk associated with information governance.

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Agenda

Location

The Olde Mill Inn
225 Route 202
Basking Ridge, NJ 07920
908-221-1100

Sitrof was glad to hear that DDMAC submissions will be accepted in eCTD format by the FDA by 2012. Our product, Approve-PTS will be enhanced to support this. Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing marketing materials to get reviewed, approved and published in the most efficient manner possible.

Speaking of Microsoft, we saw their huge display booth along with NextDocs and Liquent – their offerings look good and traffic was high at all three booths. We imagine booth traffic was higher for these vendors since both EMC (IIG) and CSC were not in attendance.

As expected, a lot of sessions and vendors were talking about the cloud. In the content management space, companies like Box and SpringCM are gaining traction but it’s clear the life sciences industry is not ready to put their GxP related documentation in the cloud without it first being validated. Vevva Systems is looking to change that with their Vault solution which is a cloud enabled content management solution built from the ground up with the Life Sciences industry in mind. It will be interesting to see how this solution can compete with traditional on-premise solutions like Documentum and SharePoint

Sodrel’s article is based on CGIRB’s transition to a fully paperless company, a process that started in mind-2008 when CGRIB teamed with Sitrof Technologies to install the Xerox DocuShare software and the Sitrof Compliance Module for DocuShare. DocuShare was first configured to mange CGRIB’s non-regulated documents, such as vacation requests, business development information, training information, PowerPoint presentations, spread sheets, status reports, RFI’s and contracts. After giving the staff time to become familiar with DocuShare, Sitrof installed its compliance module a year later. These systems help to automate the workflow and decision process and improve efficiencies and customer service.

CGRIB was able to transform from a heavily paper-centered company into a completely digital, paperless organization in less than two years. Going paperless enabled CGIRB to become more efficient in all areas, with the added bonus of becoming more environmentally friendly. Sodrel encourages paperless transitions in order to help an IRB quickly collaborate, share documents, and review protocols.

Click here to read the full article.

Copernicus Group IRB is a paperless office whose shift from being paper-based was led by Sitrof Technologies in a large, three-phase project. This has saved the organization more than $2 million on shipping, printing, postage, and file storage. Sitrof’s installation has translated to CGIRB becoming 98% paperless.

CGIRB was honored by InfoWorld for being one of the most innovative IT initiatives that fall under the umbrella of sustainability. The award honors companies who have embraced green technology to drive projects and develop products aimed at boosting energy efficiency, trimming waste, and reducing or eliminating the use or the production of harmful substances are selected for the Green 15.

CGIRB staff can now digitally search through 5 million pages' worth of legacy documents and process client submissions into the electronic workflow in an average of 3.7 minutes, as compared to 104 minutes in its paper-based era. Less time, money and effort are spent on everyday tasks, making CGIRB more efficient and green, thanks to the Sitrof installation.

To learn more about the InfoWorld Green 15 and read the complete list of winners, please click here.
To read the full case study on Sitrof and CGIRB, please click here.

The panel will discuss topics around capture, store, share and control within ECM, focusing on going paperless. Attendees will be provided with recommendations, best practices and challenges that businesses and organizations face when trying to move to a paperless environment.

"Sitrof has led a number of paperless initiatives in highly regulated industries," said Reynolds. "I’m looking forward to speaking about the numerous benefits of going paperless, as well as the challenges involved."

The AIIM Garden State Chapter panel event will be on Tuesday, May 10 at the Woodbridge Hilton in Iselin, NJ. The event starts with a networking session at 5:30pm. Click here to learn more or to register.

About Sitrof
Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof email sales@sitrof.com.

Please come visit Sitrof at DIA EDM in booth #205 to see how Approve-PTS can work for you.

Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing marketing materials to get reviewed, approved and published in the most efficient manner possible. Jobs are routed via built-in workflows with annotations and version control to retain full audit trail.

“We developed Approve-PTS for a pharmaceutical company to reduce the time needed to circulate, review and approve promotional materials and maintain compliance,” says Bryan Reynolds, co-founder and managing partner of Sitrof. “There is a tremendous need for this product and building it on SharePoint 2010 has been key to quickly launching solutions in a timely fashion.”

Approve-PTS reduces previously untrackable delays and logjams. Reviewers are notified via email that a job is waiting their review. Digital signatures with automatic date and time stamp ensure 21 CFR Part 11 compliance. In addition, advanced reporting tools allow marketing communication specialists and administrators to collect thorough metrics to resolve delays and improve the process.

About Sitrof

Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof or Approve-PTS please visit http://sitrof.com

About DIA EDM

For 23 years, DIA EDM Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s show will focus on The Intersection of Data, Documents and Submissions.

Media Contact:
Gwen Hoover
Altitude Marketing
gwen@altitudemarketing.com

Sitrof Technologies is pleased announced the end customer, Copernicus Group IRB (CGIRB) was named a finalist for the 2011 AIIM Best Practices Award. The Carl E. Nelson Best Practices Award was established to recognize excellence in information management.

Sitrof Technologies implementation of Xerox Corporation’s DocuShare® enterprise content management (ECM) was recognized as a finalist in the Small Company category for their work in transforming Copernicus Group IRB into a paperless company. CGIRB is now 96% paperless after the 2 year implementation. The paperless endeavor involved a massive legacy document scanning operation, including 1.5 million legacy documents totaling 5 million pages, as well as all internal documents and all inbound paper and electronic documents. Utilizing the Sitrof Compliance Module for DocuShare, CGIRB is able to maintaining FDA 21 CFR Part 11 compliance.

“We are excited to be a finalist,” said Bryan Reynolds, Managing Partner of Sitrof Technologies. “This was a huge undertaking requiring a lot of time and resources. The success of the project was due in a great part to the multi-phase plan developed by CGIRB’s director of IT, Jennifer Sodrel. Internal change management can sometimes be the most difficult part of a paperless implementation and Jennifer nailed it.”

"The quality of the submissions for the Carl E. Nelson Best Practice Award continues to improve raising the bar on best practices while emphasizing innovation, benefits and lessons learned," said John Mancini, President, AIIM. "Our AIIM Emerging Technology Advisory Group (EmTAG) selected the finalists in each category for the Best Practices Award. Our professional members are determining the winner in each category. Each of the finalists share many valuable lessons learned to help others with their implementations.”

AIIM professional members will chose the winner from the finalists. Award winners will be announced at the AIIM Annual Awards Celebration, March 22 at The W Washington, DC, where John Mancini, AIIM’s President, will announce the winner.

About Sitrof Technologies

Founded in 1999, Sitrof Technologies provides a new breed of information management, data protection and compliance solutions. Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk.

To learn more email sales@sitrof.com or call 866-545-8954.

Media Contact:

Gwen Hoover
Altitude Marketing
gwen@altitudemarketing.com

Princeton, NJ, January 21, 2011- Sitrof Technologies, a company that provides premier consulting and technology solutions, announced today that they will be attending the DIA Electronic Document Management 2011: The Intersection of Data, Documents and Submissions Conference (DIA EDM).

DIA EDM will take place in National Harbor, MD from February 15-17, 2011. The Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation. Please come visit Sitrof at booth #205, as we have some exciting new offerings to make document management and compliance a snap.

"We are excited to have the opportunity to attend this year’s conference," says Bryan Reynolds, managing partner and co-founder of Sitrof Technologies. “Stay tuned for an announcement of a new offering for life sciences to streamline the management of marketing and promotional materials.”

About Sitrof

Founded in 1999, Sitrof Technologies is a privately held profitable company with headquarters in Princeton, NJ, and offices in San Francisco and London. Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk. To learn more visit http://www.Sitrof.com, email sales@sitrof.com or call 866-545-8954.

About DIA EDM

Over the past 23 years, DIA EDM strives to teach participants to recognize the challenges and complexities of globally managing information, explain the importance of aligning standards, technology and leveraging interoperability, recognize the vital role of metadata in the intelligent management of data, documents and submissions as well as identify trends and standards in electronic records. To learn more about DIA EDM visit http://www.diahome.org/DIAHome/Home.aspx.

Once again the team at Sitrof is looking forward to exhibiting at the DIA EDM show, February 15-16 at the Gaylord National Hotel and Convention Center. Please come visit us at booth #205, as we have some exciting new offerings to make document management and compliance a snap.  Our newest product is built  on the industry standard Microsoft SharePoint 2010 for ease of integration into all other collaborative and document management systems. A version is also available for EMC Documentum.  In addition we will continue to support, configure and install life sciences application on both CSC FirstDoc and CSC FirstPoint.

Over the past 23 years, the DIA EDM Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation. Additionally, the design and development of business processes to facilitate the conversion of data into document components resulting in high quality regulatory submissions will be examined. Managing information in a completely electronic environment and enabling the current and future electronic submission standards landscape are key focuses.