“All business organisations will benefit”

Talking with Sparta Systems about the benefits of implementing its TrackWise® quality and compliance management software.

NGP. The European Medicine Agency (EMEA) has recently implemented your TrackWise quality and compliance management software. How will it benefit the EMEA and why they have decided to opt for your solution?

The EMEA will initially use TrackWise® to manage audits, along with the resulting observations, opportunities for improvements, and follow-up actions. In addition, the EMEA will use TrackWise® to manage SOPs and risk assessments within their organisation. TrackWise® will replace paper-based and Microsoft Excel-based systems that are currently used by the agency.

Not only will the EMEA realise the benefits of TrackWise® by tracking, trending and managing their consolidated information in a controlled manner, but the innovation and transparency of the improved approval process will benefit our global customers as well.

The EMEA evaluated more than 25 vendors before selecting TrackWise® as its quality management and tracking system; the ease of configuration, its intuitiveness and the ability to integrate with existing software, such as EMC Documentum® , were key factors in their decision. Sparta’s well documented audit trail, electronic signature, and FDA regulatory expertise gained through industry experience fulfilled the technical specifications set by the European Medicines Agency for quality process management.

NGP. Tell us a little bit about Sparta Systems’ vision and where it fits in the life science landscape?

Sparta’s flagship product, TrackWise® , was developed with the vision that all business organisations would benefit from using a versatile, powerful, off-the-shelf management and tracking tool that is user-configurable. Highly regulated industries, such as pharmaceutical, biotechnology, medical device, food, and chemical, are faced with the need to accurately manage, track, and trend a vast number of quality (GxP) issues, such as complaints, deviations, investigations, out-of-specifications, corrective and preventive actions (CAPA), change control, audits, observations, regulatory commitments, and others.

Managing, tracking, and electronically routing these types of issues and actions requires a harmonised, cross-functional and interdepartmental approach as process management functions extend across the supply chain.

NGP. How has the regulatory environment in the European pharmaceutical sector changed in the past decade and how has this influenced the way that pharma firms approach their operations?

Over the past few years, as regulatory requirements from the FDA and the EMEA were increasing and more demanding, the European life science industry has been striving toward a vision of a global harmonised and centralised quality management system. In the past, the operations of many leading global life science companies were often comprised with paper-based systems, Excel spreadsheets, home grown solutions and others which were not integrated and harmonised within and across the sites. The global drive and trend is towards a system which will effectively and efficiently manage their quality processes and enforce their procedures, providing obvious benefits such as harmonised business processes across the entity, consolidation of information, reduced compliance risk, simplified searching and reporting capabilities, and maintenance of one system, in other words: say what you do and do what you say = control.

NGP. How valuable is the implementation of TrackWise® to the customers? How do they consider return on investment of the system?

Organisations prepare a cost justification for any capital expenditure. Each company’s monetary figures are different because these calculations are based on internal costs and figures, however, based on Sparta’s experience in the life science industry, in particular, pharmaceutical, biotechnology, and medical device companies, the following key benefits are always valid for ROI when considering TrackWise® :

Revenue

Companies are generating revenues by selling products. Product cannot be released if it is being “held” due to quality issues. Any quality issue such as deviations, non-conformances, out of specifications, etc., requires a delay in the release of product until a quality review has been performed. The company’s revenue is partly a function of the length and efficiency of the quality review function. TrackWise® significantly reduces the “cycle time” of product disposition due to its ability to streamline and automate the process. TrackWise® eliminates the administrative tasks that unduly lengthen and sabotage the process.

Compliance

Compliance with regulations (e.g., FDA, EMEA, local agencies) minimises the risk of penalties, fines, closing of facilities, etc. All of which have a significant impact on a company’s financials. The health authorities have levied direct fines in excess of hundreds of million of dollars for those entities that were deemed out-of-compliance. The effect of non-compliance is not strictly the fine levied, but also the effects on stock price, reputation in the industry, lost business contracts and revenues, closer scrutiny by regulatory agencies both in continued business and new product applications.

Streamlining of IT operations

TrackWise® , as a centralised database, services all sites and harmonises all required processes in a global application. A case study performed by one customer found the following costs savings:

“TrackWise® eliminated the US$5.6 million cost of updating or redesigning more than 15 existing databases for CAPA, non-conformances, and complaint investigations across our manufacturing sites. It eliminated the need to build such applications at smaller sites. The centralisation of the database with TrackWise® also eliminated US$300,000 of annual labour to maintain and support this menagerie of databases.”

Harmonisation of business processes

Today global companies are successfully harmonising quality processes across their sites. TrackWise® is enabling companies to enforce their business rules and automate their processes. TrackWise® engages the appropriate employees for input, and automatically routes the process from initiation through completion. Any delay will trigger notifications and escalations and force visibility to areas that require them.

Prior to TrackWise® , issues were lost (the consequences of them could be fatal), and/or mishandled leading to lost time and money.

Costs

There is a direct relationship between monies spent on quality and company’s costs. For example, an effective QMS will greatly increase communication among the company’s quality department thereby eliminating duplicative efforts. Human resources that were sent chasing and tracking documents can now be put to more productive efforts, whether to resolve additional issues, or using “saved” excess time to investigate issues more thoroughly.

On the regulatory front, pharmaceutical companies must cope with growing scrutiny from government bodies and a complex regulatory regime, while simultaneously running a profitable business. Perhaps you can provide a short case study of how your tool assists such companies.

A key component of the TrackWise® system is the TrackWise® Coordinator, a state-of-the-art, fully configurable, 24x7 business rule engine, which implements automated escalations, alerts, routing, trending, distribution of reports, and much more. The following business case illustrates the above…

ABC Co. manages quality events in TrackWise® ; among them complaints. Pharma ABC’s procedures dictate response to the complainer within 30 calendar days. In addition, complaints for a particular product are assigned to the relevant QA Manager (in this case Declan Thomas). Moreover, if the result of the adverse event decision tree is that there is an adverse event related to this complaint, a vigilance report should be created and submitted.

TrackWise® eliminates the need for user date entry for certain information. If business rules are known in advance, as is often the case, e.g., standard operating procedures; TrackWise® will not only enforce them, but also automate them. Rather than relying on proper user training and human data entry, TrackWise® will proactively enforce the business rules thereby eliminate data entry errors. In the example above, once the complaint is logged to the system, the TrackWise® business-rules engine will actively monitor the scenario and will perform the following actions: automatically set the due date for either 30 or 15 calendar days based on the severity fields.

Moreover, based on the product selected, TrackWise® will automatically assign the complaint to Declan Thomas. If an adverse event was part of the complaint, TrackWise® will automatically prepare the vigilance report assign it and send it via e-mail to the proper regulatory/QA manager for approval.

In addition, using TrackWise®, companies have proactively detected trends and ensured not only notification of trend levels but also automatic investigation of detected trends. Companies are no longer needed to rely on error-free human monitoring, as well as significant wasted resources doing manual searches and coordination of information sharing. TrackWise®, based on predefined thresholds limits, can automatically detect trends.

In the above example, no human monitoring is required. TrackWise® will notify the site managers as soon as the fifth deviation for product A with the same lot number is logged within the 30-day period. Moreover, if 30 such deviations are noted for product A across the ten sites within 15 days, the corporate quality department will be notified via e-mail, while an investigation will be created for the Corporate Quality Department to complete.