Gartner defines “CRM” as technologies or systems that enable a broader customer engagement business strategy. These systems span four major areas — sales, marketing, digital commerce, and customer service and support. Yet in the life science industry (that is pharmaceutical, biotechnology, medical device and diagnostics organizations), CRM is synonymous with sales and field enablement systems, given their heavy reliance on a field-force-driven engagement model. These systems support the automation of sales activities and expert engagement for organizations’ sales professionals, key account managers, medical experts and field service personnel. These systems are also central to sales and medical teams responsible for raising therapeutic awareness, delivering educational content and influencing demand, as well as nurturing contracts with HCPs, healthcare organizations (HCOs) and other medical stakeholders. In addition, these systems provide servicing as a system of record and maintaining compliance with jurisdictional regulations for capabilities such as planning, enablement, execution and analysis processes.
Digital asset management software includes capabilities for ingestion, storage, retrieval, collaboration and life cycle management of rich-media assets, including text, graphics, images, videos and audio.
Digital validation tools deliver life sciences manufacturers tools, services, expertise and applications to assure that documents, software, operations infrastructure and processes remain optimized and comply with the requirements set out for specified purposes of their intended use. Tools and services may support specific regulations or requirements, such as the U.S. FDA’s Title 21 Code of Federal Regulations (21 CFR) Part 11 and observed industry best practices (e.g., GxP, cGMP or GAMP). They help in identification, assessment and mitigation of risks associated with the validation process while also facilitating the creation, approval and storage of validation documents. These tools can easily scale with the growth of the organization, accommodating increased validation demands without a corresponding increase in manual effort.
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Gartner defines the market for quality management system (QMS) software as the business information management system that manages quality policies and standard operating procedures (SOPs). This may include, but is not limited to, customer requirements, quality documents, International Organization for Standardization (ISO) requirements, manufacturing capabilities, robust design, auditing procedures and protocols, nonconformance/risk management activities, testing criteria, and industry-specific regulations (for example, the U.S. Food and Drug Administration [FDA] or the Federal Acquisition Regulation [FAR] requirements).