Cloud Computing 1 The first part of the series2 provided a background to the guidance document and discussed the introduction to the document. The second part reviewed and discussed the data governance system.3 In this part, we will look at data criticality and the data life cycle.Establishing Data Criticality and Inherent Integrity RiskThis section of the guidance first discusses the data governance system that we discussed above and then moves on to look at data generation. The spectrum of data generation is purported to be represented by Figure 1 in the guidance, which turns out to be a diagram drawn by Monica Cahilly during the April 2014 training of the MHRA inspectors.4 However, the diagram is, to my mind, only focused on instruments and computer systems, and I have drawn up a more detailed description of what should be presented in a data integrity guidance, see Figure 1.5 it equates to Group B instruments in USP <1058> on Analytical Instrument Qualification (AIQ).6 When … [Read more...] about Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 3: Data Criticality and Data Life Cycle
What is data integration
Data Analysis 1 The first part of the series2 provided a background to the guidance document and discussed the introduction to the document. In this part, we will look at the MHRA requirement for a data governance system.Data Governance SystemThe MHRA guidance document defines a data governance system as:The sum total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle.1Let us explore what this should entail. First, no other regulatory agency is requiring organizations to have a data governance system. However, this is a good idea given the number of issues involving data integrity that have been found recently. The rationale for this is based on MHRA’s interpretation of ICH Q10 on Pharmaceutical Quality Systems (PQS),3 which is incorporated in Part 3 of EU GMP4 and that of EU GMP Chapter 1 on PQS,5 which is based in … [Read more...] about Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 2: Data Governance System
Security A look at this current emphasis and a few problems inspectors have identifiedThe integrity of data generated by a regulated laboratory can make or break a regulatory inspection or audit. This paper looks at what is required for data integrity from the basis of the GMP regulations. It presents examples of non-compliances found in warning letters and a regulatory action from the U.S. Food and Drug Administration (FDA). It only requires a single adverse non-compliance to cast a shadow over ALL work undertaken by a regulated laboratory. In this first installment of a two-part article, we will look at the background to the current FDA emphasis on data integrity and some of the problems that their inspectors have found when visiting companies.To begin a discussion about laboratory data integrity, it is necessary to start from basics, in this case the definition of integrity as being the quality or condition of being whole or undivided; completeness.1 In the context of laboratory … [Read more...] about FDA’s Focus on Laboratory Data Integrity – Part 1
Data Analysis 1-4 on the MHRA Data integrity guidance published in March of that year.5 In September 2015, the World Health Organisation (WHO) issued a draft document entitled Guidance on Good Data and Record Management Practices6 or, in other words, a data integrity guidance. Even WHO inspectors have found problems with data integrity with organizations that they have inspected. WHO do not issue warning letters like the FDA or non-compliances as do the European Medicines Agency, but Notices of Concern (NOC). Regardless of what the regulatory citation is called, what it means that these worthy organizations are staffed by naughty boys and girls who, through a combination of poor data management practices or willful falsification, have managed to earn the ire of an inspector.MHRA v WHO guidance documentsAs we now have two data integrity guidance documents available to read, let us compare them. In terms of metrics, the MHRA document is 16 pages long with three pages of guidance and 13 … [Read more...] about Review of the Draft WHO Data Integrity Guidance Part 1: Principles, Risk and Management
The contact center has become the focal point of the customer interaction. Customers spend more time researching products, managing account and order information, resolving issues, and utilizing self-service than they do within the traditional brick-and-mortar storefront. This requires contact centers to have a 360-degree view of the customer. In order to enable this, integration of data from across the enterprise has become a must for a contact center.Aberdeen Group's benchmark report, "The Intelligent Contact Center: Increasing Multi-Channel Visibility," (July 2007) reveals that 62 percent of Best-in-Class companies are in the process of providing their agents with increased access to customer data. The ability to integrate and utilize data in an effective manner will separate Best-in-Class companies from others. This new benchmark report, titled "Data Integration in the Contact Center: Providing a 360-degree View of the Customer," (May 2008) will document a road map for Laggard and … [Read more...] about EXPERT ADVICE Data Integration and the Elusive 360-Degree Customer View
Customer data integration (CDI) is becoming important for enterprises who want to target, acquire, develop and retain customers. In order to benefit from it, however, an enterprise needs to create a unified and comprehensive customer view from disparate data sources -- including CRM, financial, product and external data services. Once integrated, unified customer views provide the entire organization with the ability to drive meaningful business action within and across operational systems.As the demand for CDI grows, large application vendors have been trying to position themselves as the preferred solution providers, but their attempts often have been unsuccessful. Because these application vendors anchor their CDI solutions on their own applications (often in CRM), they lack the flexibility to become an enterprise-wide platform that delivers unified customer views across a diverse set of application systems and data repositories. Moreover, rigid frameworks sometimes limit the … [Read more...] about INDUSTRY ANALYSIS A New Approach to Customer Data Integration, Part 1
The definitions or descriptions of newly minted terms and acronyms have been flying around this past year. To add to this, I'll contribute another one: Rich Enterprise Application, or REA.To be clear from the start, REA is an evolution of Rich Internet Applications (RIA) and not an entirely new category created out of thin air. Like RIAs did for consumer facing applications, REAs offer the same advances in usability and interactivity but are designed to meet the needs of enterprises.REAs extend far beyond simple RIAs to integrate seamless connectivity between Ajax-based Web applications and Service Oriented Architecture (SOA) business services. REAs leverage investments in SOA and the power of Ajax, and combine the two to enable innovative new business and application models such as Software as a Service (SaaS), enterprise mashups, next-generation portals and browser-based composite applications.What sets REA solutions apart is that they have built-in facilities to ensure enterprise … [Read more...] about What Is REA All About?
Data integration is critical for companies that need to combine systems and databases after a merger or acquisition, or need to link legacy systems to new business applications. This need is vast throughout commercial and public industries, and the task can be daunting, especially for CIOs and IT managers of small- to medium-sized businesses, whose IT staffs and budgets may be constrained. Add to that the rise of cloud-based data integration services and the decision becomes even more confusing:"Should we implement data integration on-premise, or choose a cloud-based Software as a Service (SaaS) solution provider?"There are clear advantages to either approach, but for many SMBs, the hybrid approach -- where some data integration processes take place in one or multiple clouds and others remain behind the firewall -- is the most practical solution.It's not always feasible for companies to move all their data integration functions to the cloud. Instead, some find it more practical to "dip … [Read more...] about EXPERT ADVICE Data Integration in the Cloud – or Not
The term "marketing automation" is perhaps one of the most widely used, ill-defined and ambiguous terms in the marketing and sales technology landscape. Ask 10 different people how they define marketing automation, and you'll probably get 10 different answers.Are there marketing automation solutions? Is it a category? Is it a type of technology? Or is it just a bunch of hooey?As an analyst, I thought it would be appropriate for me to dispel some of the myths and haziness that shroud the marketing technology landscape, particularly the use of the term "marketing automation." In my opinion, much of the uncertainty and ambiguity has stunted growth of technology that will be critical for every company to embrace in order to maintain a competitive foothold in the market. The research I have conducted has consistently shown that marketing automation technology has a direct impact on bottom-line cost reduction and top-line growth. However, before we tackle that, let's define "marketing … [Read more...] about ANALYSIS What Is Marketing Automation and Why Should You Care?
Several years ago, a large manufacturing company lost a key distribution center to a fire. The fire destroyed not only the building, but also thousands of shipments destined for a global customer base.Naturally, the CEO of this company wanted to send a letter to customers to explain the situation and to provide a timetable for when operations would return to "business as usual." The CEO passed the request to the vice president of customer relations, who in turn asked IT to generate a list of all customers for that particular center.The IT staff pulled reports from its customer relationship management, enterprise resource planning, and billing and supply chain management systems. What they found reveals a distressing but pervasive problem at most organizations.Each list contained different, overlapping and confusing views of the customer base. Some names were listed or spelled slightly differently; some addresses were a bit off. The end result was that this company could not create an … [Read more...] about EXPERT ADVICE Data Integration Drives Healthy Customer Relationships