How Life Science Organizations Can Leverage Technology to Achieve Compliance with GMP Standards

Janet Sanders

Janet Sanders

Attorney, Business Analyst and Certified, Project Management Professional (PMP) with extensive experience in all aspects of requirements analysis, project management and the systems development life cycle responsible for providing consulting services in the Pharmaceutical/Life Sciences environment.

Life sciences organizations face more pressure than ever to achieve operatingScattered Folders efficiencies, minimize risk and achieve cost savings. Information is the lifeblood of an organization, and failing to manage the exploding data and documents typically scattered throughout the enterprise can sabotage an organization’s efforts to achieve its operating objectives.

Unfortunately, many organizations find themselves in “reaction” mode, often employing ad hoc information approaches that can be implemented fairly quickly with familiar technology. All of this leads to disparate and unreliable solutions that can also render an organization vulnerable when it comes to managing compliance with GMP standards.

Gaining Control with Enterprise Content Management

Another approach is to tackle the data explosion head on by viewing technology not just as part of overhead, but as a key strategic asset. The question becomes “What is the best approach for moving forward?”

One option is to implement an Enterprise Content Management solution known as “ECM”.
At its core, ECM is comprised of integrated strategies, methods, and technologies that consistently create, store, distribute, discover, archive and manage content across the enterprise. A well designed ECM solution supports compliance with GMP standards through automated management of standard operating procedures and process control documents.

The technology is important, but it is just the beginning. To achieve the full benefits of ECM, consistent end user adoption is critical. So, before you select and implement a solution, consider the following:

Consistency and Accountability:

  • Select a system designed to provide a consistent user experience with vendor accountability throughout the process
  • With EMC’s Documentum for Life Sciences solution suite, the application layer and repository are built and supported by the same vendor. This approach promotes accountability, dependable development standards and simplified training – all of which supports increased efficiency and effectiveness of workers sharing data.

Ease of Use:

  • If a system is hard to operate, users won’t adopt. For compliance objectives to be reached the system has to be used, and used correctly.
  • For optimum results, implement a system that provides an intuitive interface with the ability to be configured to provide personalized views and functionality that meets the types of requirements found in life sciences organizations.

Configuration vs. Code:

  • Implement a system that can provide a truly configurable user experience.
  • For example, the EMC Documentum for Life Sciences solution has removed the need for custom coding simplifying the user experience and enhancing the productivity of knowledge workers by easily tailoring their user experience for their specific requirements.
  • The configuration approach expedites project implementations and reduces total cost of ownership while enabling life sciences organizations to build and deliver content centric solutions to meet the needs of the business.

With careful planning, life science organizations can achieve compliance with GMP standards through a proactive implementation of ECM that leverages technology and fosters consistent use for effective content management throughout the enterprise. Check out our website for more information.

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