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Behind the Code: Building Regulatory-Compliant Clinical Software

In the digital health and clinical research space, software isn't just a tool—it’s a regulated asset. Whether managing trial data, powering diagnostics, or enabling patient engagement, these systems must meet rigorous standards for quality, security, and data integrity. At Touchcore Systems, compliance isn’t an afterthought. It’s a core design principle, embedded across every stage of the software development lifecycle.


As an ISO 9001:2015 and ISO/IEC 27001:2022 certified organization, Touchcore is committed to delivering clinical-grade software that is not only high-performing and secure but fully aligned with global regulatory expectations—21 CFR Part 11, GxP, and ISO standards alike.

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Compliance by Design: It Starts Before the First Line of Code

Touchcore’s process begins with understanding the regulatory landscape of the solution being developed. Our product, quality, and regulatory teams collaborate from the outset to define:

  • Applicable Standards & GuidelinesWhether it’s a system subject to 21 CFR Part 11 (electronic records/signatures), GxP (Good Clinical/Laboratory/Manufacturing Practice), or ISO 13485 for software classified as a medical device.

  • Risk-Based ClassificationWe perform system impact assessments to determine the level of validation and documentation needed.

  • Quality and Security PlanningEvery project is governed by a tailored Quality Management Plan (QMP) and Information Security Management Plan (ISMP), aligned with our ISO certifications.


Agile Development Within a Regulated Framework

We pair agile methodology with regulatory discipline. Our teams follow iterative development while maintaining rigorous documentation, traceability, and quality controls.


Here's how:

  • Requirements TraceabilityEvery feature and user requirement maps to design inputs, test cases, and verification outcomes.

  • Secure SDLC ToolingOur validated Application Lifecycle Management (ALM) platforms maintain complete audit trails and version control.

  • Controlled ChangesFormal change management, impact analysis, and approvals are enforced before code changes are merged or released.


Ensuring Part 11 Compliance: Data Integrity, Authentication, and Signature Control

For software systems governed by 21 CFR Part 11, Touchcore implements:

  • Robust Access ControlsMulti-factor authentication, role-based permissions, and session monitoring.

  • Tamper-Proof Audit TrailsImmutable logs of user activity, data changes, and system access.

  • Electronic Signature BindingUnique, verifiable e-signatures tied to user identity and intent.

  • Validation DocumentationWe develop and maintain Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) records, alongside trace matrices and summary reports.


GxP-Compliant Infrastructure: Built for Trust and Auditability

Our infrastructure and DevOps practices reflect our commitment to GxP and ISO/IEC 27001:2022 requirements:

  • Cloud Environment QualificationHosting environments are qualified with SOPs for access, backup, patching, and business continuity.

  • Vendor Risk ManagementAll third-party services go through formal qualification and data protection reviews.

  • Disaster Recovery & RedundancyData is encrypted, backed up securely, and recovery procedures are tested regularly.


Quality and Security: Certified from the Ground Up

Touchcore’s certifications in ISO 9001:2015 (Quality Management) and ISO/IEC 27001:2022 (Information Security Management) are more than credentials—they shape how we operate every day.


Our certified processes include:

  • CAPA & Nonconformance HandlingWe log, investigate, and resolve all deviations systematically.

  • Internal Audits & Continuous ImprovementPeriodic assessments help us stay ahead of compliance and client expectations.

  • Security Awareness & Regulatory TrainingOur staff undergo annual training on GxP, ISO standards, data privacy, and secure coding.


Final Stage: Testing, Validation, and Release

No system goes live without exhaustive testing and documentation. This includes:

  • User Acceptance Testing (UAT) with traceability to each user requirement.

  • Formal Release Reviews with QA, security, and client representatives.

  • Validation Packages that clients can use during sponsor or regulatory audits.


Conclusion: Compliance is in Our Code

At Touchcore Systems, we understand that regulatory compliance is not just a requirement—it’s a promise to our clients and their stakeholders. From biotech innovators to clinical research organizations, our partners trust us to build software that stands up to regulatory scrutiny and drives real-world impact.


Compliance isn’t a box we check. It’s how we build.

 
 
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