Government

WHITE PAPERS AND CASE STUDIES

• Texas Cardiology Research Department Transforms Document Access, Fuels Productivity

  What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.

• Bio4C ProcessPad 21 CFR Part 11 Compliance White Paper

  Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.

• What Is The True Cost Of Not Having An eQMS?

  It is safe to assume that no organization that intends to stay in business sets out to manufacture or provide a low-quality product. This is particularly true for highly regulated companies. And yet switching from a manual quality management system (QMS) to an electronic one in order to improve product quality and ensure regulatory compliance remains low in most companies’ list of priorities. In this white paper we discuss the most common “quality pains” I’ve seen among regulated companies and offer some strategies on choosing and executing an eQMS.

• Automating Backup: Opportunities & Best Practices

  You already know that backing up your organization’s data isn’t a nice-to-have, it’s a need-to-have. The external threats alone warrant this. You could be one of the 50% of all organizations operating a data center that can’t withstand, or is unable to operate after, a natural disaster. Or, you could be one of the 39% of global organizations that experienced a ransomware attack in recent months.

• Global CRO Embraces On-Demand Training And Achieves 100% Business Continuity During COVID-19

  Before the COVID-19 pandemic, a leading global CRO used on-demand investigator training services in addition a traditional, in-person training program until almost overnight, face-to-face training became impossible. This case study describes how this CRO embraced on-demand virtual training services and achieved 100% business continuity amid the COVID-19 pandemic.

• How Modern Ultrasonic Controllers Can Help Water Utilities Save On Energy

  In industry today, everyone is looking for ways to conserve a bit of energy and save some money. For instance, consider the energy consumption across the United States just in the water treatment process. With thousands of public water utilities, the amount of energy usage is significant.

• When ‘Okay’ Data Protection Is Not Enough

  Contigo Technologies is a leading MSP based in Austin, Texas. While many MSPs focus on particular verticals, Contigo’s technical and service offerings have made them the “go-to” MSP for businesses across the Austin area. An example of their commitment to customer service is that they place an icon on every supported workstation that lets the user contact Contigo in a matter of seconds, whether to access support or just ask a question.

• 21 CFR Part 11 — Are You Ready For An FDA Inspection?

  Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.

• Cubic Transportation’s Outcomes-Based Service Success

  Service organizations across the globe are painstakingly aware that the historical break/fix service model is no longer satisfying customers. Rather, customers are demanding outcomes – uptime, peace of mind, and results. The adaptation necessary to meet these ever-increasing demands is no small feat, which is why we see plenty of companies struggling to evolve. There are those, though, which have tackled this transformation with steely resolve and are leading the charge in delivering what today’s customers want. Cubic Transportation Systems is one such example.

• Inova Health System Uses Advarra eReg Workflows And Integrations To Improve Regulatory Efficiency

  Maintaining efficient, effective regulatory management processes can be a significant challenge. At Inova Health System, the research team improved regulatory efficiency by 20% without the need for extra regulatory staff by adopting Advarra’s eRegulatory Management System.

• Clinical Trials Are Better, Faster, Cheaper With Big Data

  The path from study design to approval is long, winding, and expensive. Explore how researchers are using artificial intelligence and advanced analytics to speed up the process, reduce costs, and get effective treatments swiftly to those who need them while tapping into data on patients from past trials.

• Meeting Customer Demands For Clean Water At Bristol Water

  Bristol Water provides clean, fresh drinking water every day to approximately 1.2 million people in the city of Bristol and surrounding areas in the west of England. As part of taking inventory on ways to improve its service, Bristol Water undertook its largest ever program of customer engagement. This invited customers to participate in the decisions Bristol Water makes about the future of their water services.