The Life Sciences (LS) industry produces goods and services intended to improve both human and/or animal health conditions and therefore is held to high standards of quality and public trust. The need and ability to design and produce affordable, innovative products continues to rise even as regulators are demanding more transparency.

In the US, Life Sciences companies are regulated by the US Food and Drug Administration (FDA) with the objective of ensuring patient safety, product quality, and data integrity. Regulators have acknowledged the impact and pace of change brought in by newer technologies and are facing challenges themselves in keeping up with the pace at which the industry is growing. FDA is also benefiting from more collaborative approaches, such as co-regulation, self-regulation, and international coordination.

Life Sciences industries may also be impacted by several other regulations, guidelines, standards, and frameworks. Regulations impact many areas such as financial integrity (SOX), privacy (HIPAA, CCPA), and security (FISMA / FedRAMP). Regulations are legally binding and issued by regulatory agencies based on federal and/or state laws such as the Federal Food, Drug, and Cosmetic Act (FD&C Act). Regulatory agencies also issue non-binding guidance that describes their thinking and provides recommendations on specific regulatory issues, such as FDA’s Guidance for Industry - Part 11, Electronic Records and Electronic Signatures — Scope and Application. Apart from regulations and guidelines, there are standards that are set by professional associations or independent bodies, and are widely adopted within the industry. Examples of standards include International Organization for Standardization (ISO 27001), Payment Card Industry (PCI Data Security Standard), and International Society for Pharmaceutical Engineering (ISPE GAMP 5). Frameworks are issued by government bodies or professional associations and provide general direction but are more flexible compared to standards. Examples include FDA Real-World Evidence and NIST CyberSecurity.

The key areas covered by these regulations are:

• Security: encompasses the measures that need to be taken to prevent or reduce the threat of unauthorized or inappropriate access to facilities and systems.

• Privacy: is the state of being free from unauthorized collection, storage and/or use of personally identifiable information, and to prohibit any disclosure without explicit authorization or to meet a regulatory requirement.

• Change Management: is the process of controlling the life cycle of changes. The primary objective of change management is to enable beneficial changes to be made, without compromising regulated processes or records and with minimum disruption to services.

• System Development Life Cycle: attempts to streamline the process of development that ensures software quality traceable through requirements, development, testing, deployment, and revision.

• Quality System: represents the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

• Data Retention: defines the requirements to store data in a secure, retrievable form based on legal, regulatory or business needs

• Incident Management: is the practice of minimizing the negative impact of incidents by restoring normal operations as quickly as possible in a secure manner.

It’s important to note that while the various regulations contain many overlapping domain requirements, there are differences between them that Life Sciences organizations must consider when attempting to address all of their regulatory obligations.