Digital Future
ONTARIO
Embracing the Digital Future: The Challenges of Managing Information in Life Sciences
By Ferdi Steinmann
M
anaging information is critically important to life sciences companies. Creating new products can take years of trial and error and every step in the process must be documented thoroughly—not only to speed internal development, but also to satisfy the needs of external partners and regulators. As a result, organizations in the life sciences industry can benefit from incorporating enterprise information management (EIM) solutions that have a proven record of quality and a history of meeting regulators’ needs. These solutions offer features such as workflow management, version control and audit trails, which are critically important for complying with regulations. The need for information management platform solutions is increasing as new challenges face organizations within the life sciences industry. Competition is fierce, and companies are trying to balance the need to create innovative new products and research, while ensuring they carefully document every process and stay on top of regulatory compliance.
24
Biotechnology Focus
June/July 2019
It is a daunting task, but those who master it will have an edge over their competitors. Following are some of the key challenges life sciences companies must overcome if they hope to succeed.
Continued regulatory environment growth Life sciences companies are required to comply with a complex and growing set of regulations. These include: • GxP, which covers an array of compliance activities, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), designed to ensure medical products are safe and meet high quality standards throughout production. In Canada and the U.S. specifically, drug and health manufacturers must follow Good Manufacturing Practices (GMP), • Compounding standards governed by the National Association of Pharmacy Regulatory Authorities, and • ISO certification, which provides requirements and guidelines ensuring that processes and procedures in the manufacture of drugs are followed.
These regulations can vary from country to country, making compliance difficult to track for multi-national organizations. The regulations are also constantly evolving and organizations are mandated to keep up with these changes. For instance, one method of achieving this is through content management and digital solutions which are updated on a regular basis to ensure organizations have the proper regulations in place and are adhering to those regulations. Using a digital platform will assist these organizations to comply with any regulatory audits more efficiently.
Siloed information Too often, important information and documentation are kept within one functional area of a life sciences company. For example, in research and development departments, much of the information generated is stored in a silo application not searchable across the enterprise, limiting its capabilities. Since this information is not readily available, it can’t easily be accessed by other departments or combined with other data sets to generate new insights that could lead to improved processes.
