Tag: Sparta Systems

Holmdel, NJ May 27, 2010 – Current and anticipated regulatory changes are the chief driver of life science organizations’ quality management initiatives, according to a recent poll by Sparta Systems, the maker of TrackWise® software. Ninety-seven percent of quality professionals surveyed indicated that regulatory concerns impact their company’s quality management initiatives either greatly (58 percent) or somewhat (39 percent).
As authorities continue to strengthen their oversight of regulated industries in 2010 – from the increased frequency of audits designed to eliminate product recalls to new guidelines for ensuring food safety – quality management is becoming more proactive than reactive for both agencies and manufacturers. More than three-quarters (78 percent) of respondents to the Sparta Systems survey cited compliance concerns as a major reason for implementing the company’s TrackWise enterprise quality management software (EQMS), while 56 percent indicated improving operational efficiencies was a significant reason for deploying the software.
The survey also revealed that many companies’ quality and compliance improvements are being driven by top-level executives—not just IT departments or quality managers. In fact, the majority of life sciences organizations surveyed by Sparta Systems (91 percent) indicated that their top executives realize the business value of quality and compliance initiatives. Overall, EQMS software was widely cited by survey respondents as a business-critical investment (71 percent) that is being leveraged across multiple international locations (78 percent).

Holmdel, NJ Apr 21, 2010 – Sparta Systems, Inc., the maker of TrackWise® software and the market leader in enterprise quality and compliance management solutions, today announced the release of its TrackWise Audit Execution Package. The new offering builds upon the existing robust audit capabilities in the TrackWise solution, providing auditors with an innovative solution that accelerates the efficiency and compliance of conducting audits in the field.
As authorities strengthen their oversight of regulated industries and increase the frequency of inspections, companies must be prepared to not only meet strict internal operational compliance requirements but also ensure the quality of goods and services provided by an increasingly global network of suppliers. Sparta System’s TrackWise enterprise quality management solution (EQMS) offers these companies comprehensive functionality for ensuring compliance with diverse global regulations and industry standards. The TrackWise Audit Execution Package provides a number of new capabilities designed to increase the efficiency of field audit execution and reduce error-prone manual steps. The new features and capabilities include:
• Company auditors can now access all relevant audit information offline, while in areas without internet or VPN access, including general audit information, templates/plans and the ability to author related observations/findings
• Audit information is presented to the user in a cohesive, intuitive format that balances the look and feel of a continuous “document-like” format with the inclusion of dynamic navigation, structured data fields and a modern rich text authoring capability
• Draft audit reports can be generated in real time, in the field, without having online connectivity
• The solution allows auditing programs to include questionnaires or self assessments that can be distributed to suppliers and other third parties as an alternative or precursor to onsite auditing activities
The new functionality is powered by modern, lightweight, Adobe Flex-based technology that delivers rich form-based functionality in a structured solution that eliminates difficult-to-validate local application and database software
Additionally, implementing TrackWise for audit management processes not only enables the execution of audits, but also provides mature functionality for following up on all identified findings and action plans. Powerful user dashboards, reporting and automated business rules and escalation paths can be implemented in conjunction with all aspects of the audit management lifecycle.
“With our new Audit Execution Package, companies now have a broad set of additional capabilities available as they continue global audit management programs and align multiple auditing functions,” said Mike Jovanis, vice president of product management at Sparta Systems. “We are excited to deliver a solution that not only dramatically increases the efficiency of auditors’ work in the field, but also adds structure and security to a process that has historically included open, non-secure cutting and pasting from word processing tools.”

Holmdel, NJ Mar 10, 2010 – Sparta Systems, Inc., the maker of TrackWise® software and the market leader in enterprise quality and compliance management solutions, today announced that a significant percentage of medical device companies currently submitting “high–volume” reports, leverage its TrackWise enterprise quality management solution for automated report submission to the FDA. These early adopters have taken proactive steps to comply with the electronic Medical Device Reports (eMDR) guidance, accelerating their realization of significant operational efficiencies and hard dollar savings over the manual, paper-based methods of the past.
The proposed eMDR regulation would require medical device companies to submit adverse event reports to the FDA’s Center for Devices and Radiological Health (CDRH) via an electronic gateway. In November of 2009, the agency closed the period for companies to submit comments on the proposed requirement, and industry experts expect the rule to become mandatory within 12 months, leaving little time for device makers to prepare for automated report submission. Many medical device companies have not yet been proactive in implementing an electronic submission system, while those that have done so have already realized demonstrable improvements in operational efficiencies and significant cost savings while preparing for compliance with the looming mandate.
TrackWise software automates the eMDR submission process for device manufacturers in the high-volume category, enabling successful reporting to CDRH in a fraction of the time previously spent on manual, paper-based submissions. Sparta has worked with a large percentage of the companies currently live with eMDR to successfully plan, design, implement and test their TrackWise-enabled eMDR system, helping ensure that reports are submitted and acknowledgements received quickly and efficiently. Alternatively, companies can manually submit these electronic reports – an option that is resource-intensive for large organizations.
“Companies that leverage the TrackWise solution for eMDR compliance have demonstrated that they realize the time-sensitive nature of preparing for electronic submission,” said Mike Jovanis, vice president, product management for Sparta Systems. “With the deadline for compliance approaching and the opportunity for significant ROI apparent, it is crucial that more device makers recognize this need and take the necessary proactive steps to comply with this long-anticipated mandate.”