Nine Steps for Launching an ERM ECOSYSTEM PLAN

By King, Morgan; Aaronson, Stephen | Information Management, September/October 2017 | Go to article overview

Nine Steps for Launching an ERM ECOSYSTEM PLAN


King, Morgan, Aaronson, Stephen, Information Management


An electronic records management (ERM) solution is not one system, but an ecosystem of policies, standards, processes, people, and tools. Like any ecosystem, it will evolve and grow based on the environmental factors surrounding it. Some of the factors that determine how this ecosystem flourishes are the industry, regulations, corporate culture, organizational commitment, and demonstrated value. This case study from an organization in a highly regulated industry provides a nine-step plan for building such an ecosystem.

Rapid Growth Demands Solution

With the rapid growth of this small biotechnology company into an industry leader through strategic investments, mergers, and acquisitions came stakeholder demands to provide a pragmatic strategy for managing and rationalizing its systems and data. The company's legal and IT departments' strategy to meet this demand entailed investing in technology, people, and processes to address different data types and business transactions and resulted in the ERM solution described below.

The Technology

The company considers its ERM solution a program rather than a stand-alone system. First, it is composed of multiple tools rather than just one. Second, it has steadily evolved through incremental investments that began with one questionnaire, one tool, and two staff members. It is now an interconnected suite of tools comprising a solution with core capabilities that include appraisal; auto-classification; redundant, outdated, and trivial (often referred to as ROT) data analysis; disposition; data migration; document holds application; archival; and unstructured, semi-structured, and structured data curation.

The People

The program now is fully staffed with electronic archivists, IT leads, database administrators, and ERM technicians, and it has a compendium of documentation, training, and operating plans that underpin the ERM solution.

The Process

The program is multi-functional and multi-jurisdictional. It is bound by the industry's best practices and the laws and regulations that govern the industry. Key performance indicators are measured regularly and the program is accountable to executive sponsors. Its value is measured via the tangible return on investment from retiring systems, reducing maintenance and licensing costs, and decreasing administrative burden.

Business Case Demonstrates Value

A "build it and they will come" strategy for developing and implementing an ERM program simply would not have worked in a competitive environment where companies are constantly challenged to drive and maintain a low general and administrative expense budget. Justifying the need for this program required showing its measurable value. The strategy for the ERM solution business case, then, was to demonstrate how the solution's capabilities would:

* Protect intellectual property

* Support the legal function as litigation and the rules for electronically stored information continually evolve

* Adhere to privacy regulations

* Manage the terabytes of data accumulated through the company's multi-billion-dollar growth strategy

Technology Determines Success

Companies in the biotechnology or pharmaceutical space must consider the industry's stringent regulations and litigious environment when choosing a technology company partner for building an ERM solution. The most important factor for ERM implementation success is to select a technology that can validate against a U.S. Sarbanes-Oxley Act (SOX)-compliant computer system, ensure compliance with regulatory best practices, and meet legal and privacy obligations.

Validation

To ensure the highest quality and integrity of the processes and data contained within a system, computer systems that handle GxP data and records are validated in accordance with the U.S. Federal Drug Administration Code of Federal Regulation 11.10(a) and the EU's equivalent, the European Medicines Agency's EMA Annex 11 Section 4. …

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