FDA-Regulated Technology & Security Compliance

FDA compliance does not forgive technology that was not built to be audited.

Life sciences companies operate under some of the most demanding regulatory environments in any industry. When the FDA audits a pharmaceutical, biotechnology, or medical device company, the technology systems that create, modify, store, and transmit regulated records are not background infrastructure. They are primary audit targets.

The regulatory obligations that govern technology and security in life sciences environments are broader than most executives realize. 21 CFR Part 11 addresses electronic records and signatures. GxP requirements govern the systems that support regulated processes. Data integrity standards apply across the full environment. Computer system validation obligations follow systems through their entire lifecycle. And cybersecurity expectations are increasing as FDA guidance continues to evolve.

Meeting these obligations is not a technology project. It is an executive governance obligation that requires sustained operational discipline across the full technology and security environment.

The Regulatory Landscape

Life sciences technology and security leaders operate within a layered set of FDA requirements and industry standards that work together:

  • 21 CFR Part 11 governs electronic records and electronic signatures used in regulated activities, requiring audit trails, access controls, system validation, and signature authentication
  • GxP requirements — Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice — impose technology and data integrity obligations on systems supporting regulated processes
  • Computer Software Assurance (CSA), the FDA’s updated approach to computer system validation, requires risk-based assessment and documented evidence that systems perform as intended
  • Data integrity requirements based on ALCOA+ principles apply to all regulated data regardless of whether it is electronic or paper-based
  • FDA cybersecurity guidance increasingly expects medical device manufacturers and other regulated entities to address security as part of product and systems design
  • GAMP 5 provides the industry framework for categorizing and validating computerized systems in life sciences environments

What FDA Inspections Actually Test

The most common technology and security findings in FDA inspections are not missing controls. They are controls that were implemented but are not being operated as designed, systems that were validated but have not been revalidated after changes, and audit trails that exist but are not being reviewed.

The gap between the validated state and the operational state is where most FDA observations originate. That gap grows when there is no executive accountable for maintaining it.

Why FDA Compliance Fails Without Executive Ownership

Life sciences companies often treat FDA technology compliance as a validation project managed by quality or IT. The validation gets done. The systems get qualified. And then the environment changes. New systems get added. Existing systems get updated. Staff turns over. Procedures drift.

Without executive ownership of the technology and security environment, the compliance posture erodes between inspections. By the time the FDA arrives, the gap between the documented state and the operational reality has grown in ways that are difficult to explain and expensive to remediate.

Keystone brings direct FDA compliance experience across multiple pharmaceutical environments. That experience is not theoretical. It includes leading technology and security organizations through FDA inspections at Genta, Regeneron, and Fougera, and building the operational discipline required to maintain compliance in live production environments across the full regulatory stack.

What FDA Compliance Looks Like with Keystone

Keystone approaches FDA-regulated technology and security compliance as an operational governance function, not a one-time validation exercise. That means:

  • System inventory and classification across the full regulatory scope, not just Part 11
  • Validation and CSA status assessment with remediation of gaps in existing systems
  • Audit trail configuration, monitoring, and review across all regulated systems
  • Access control review and enforcement aligned to regulatory requirements
  • Change control processes that trigger appropriate revalidation when systems are modified
  • Data integrity controls embedded in operational procedures, not just policy documents
  • Cybersecurity governance aligned to FDA expectations and industry standards
  • Inspection readiness maintained as an ongoing operational state, not an emergency response

Who This Is For

This engagement is for pharmaceutical, biotechnology, medical device, and contract research organizations operating under FDA oversight. If your organization is approaching an FDA inspection, has received observations related to technology controls or data integrity, or is building a technology environment that must operate under FDA requirements, this is the conversation to have.

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