Meeting regulatory requirements in the pharmaceutical, medical device and biotechnology industries is a complex undertaking. Companies must adhere to strict guidelines like 21 CFR Part 11, which governs electronic records and signatures. This demands systems that are not only effective in their primary function but also meticulously designed to support compliance activities. The right equipment can significantly reduce the administrative burden and risk associated with regulatory adherence.
This post explains how Sepha products simplify compliance by integrating technical controls into the core design of the equipment.
This article forms part of our 21 CFR Part 11 and Regulatory Compliance series, exploring how compliance requirements are implemented in regulated manufacturing.
How do Sepha products simplify compliance?
Sepha products are developed with a deep understanding of the regulatory environment in which our customers operate. Compliance is not an add‑on; it is built into the core design of our systems. We simplify compliance by providing integrated technical controls that align directly with the requirements of regulations like 21 CFR Part 11, reducing the need for extensive manual oversight and complex procedural workarounds.
Each system operates on a validated Windows IoT Enterprise LTSC platform with its own built-in PC, removing dependence on external hardware. Machines can connect to the customer’s network to store and review reports on secure servers, supporting collaboration and centralised data management.
Systems support secure data-exchange protocols that enable electronic batch records and test results to integrate with enterprise QMS and MES platforms, giving organisations a single, traceable source of truth across manufacturing and quality functions. Comprehensive batch reports include quantitative test results, statistical summaries, and alarm tracking. Each report is automatically linked to the operator’s user credentials, whether managed locally or through Active Directory authentication, enabling electronic signatures for batch close, review, and approval.
Robust user authentication and role-based permission controls restrict actions to authorised personnel. Built-in validation checks and self-diagnostics help maintain data integrity by ensuring systems operate as intended. Cybersecurity features include encrypted communication, role-based access, and operation within the Microsoft LTSC security-patch framework, supporting deployment within enterprise IT-security environments. By embedding these compliance functions within the equipment design, Sepha helps manufacturers reduce human error, strengthen data integrity, and maintain a constant state of audit readiness with less effort.
What validation checks are built into Sepha products?
Validation is a fundamental regulatory expectation for any computerised system used in a GxP environment. Sepha develops and verifies its software under a defined quality-management system, following a risk-based lifecycle approach consistent with ISPE’s GAMP 5 framework. Each software release is qualified through a formal test plan to confirm that functionality meets the approved software design specification and that compliance features operate as intended.
Equipment is checked and calibrated before shipment to verify correct operation within specification. Sepha provides IQ/OQ documentation and method-development support to assist customers in qualifying equipment and defining validated parameters within their own validation lifecycle.
How do Sepha’s products handle user authentication and permissions?
Effective user authentication is critical for ensuring that all actions on a system are attributable to a specific, unique individual. Sepha products enforce the use of unique user IDs and password. They can integrate with Active Directory for central authentication, or use local user accounts where appropriate. Role-based permissions implement least-privilege access so operators can execute assigned tasks without deleting GMP records or changing administrative settings.
For example, an operator might be granted permission to run tests, but not to change test methods, alter system settings, or delete GMP records. A supervisor or QA approver would have a higher level of permission, allowing them to review and approve records.
How does Sepha’s centralised time source ensure accuracy?
Accurate and reliable timestamps provide an objective record of when an event occurred, which is essential for demonstrating that procedures were followed contemporaneously. Sepha systems record each action using the local system clock, which is protected from alteration by standard user accounts. Only authorised administrators can adjust system time settings under controlled conditions.
When connected to a customer’s network, the clock can also synchronise automatically with an approved Network Time Protocol (NTP) source, ensuring consistency across all connected systems. Every record and audit-trail entry is automatically time-stamped, providing a clear, traceable chronology of activity for audit purposes.
What support does Sepha provide to understand compliance?
Technology alone cannot ensure compliance; personnel must be properly trained on both the system’s operation and the relevant regulatory principles. Sepha provides comprehensive support to ensure customers are well‑equipped to use our products in a compliant manner.
Our support begins with installation and commissioning, where our qualified technicians provide initial training for operators and administrators on system operation and compliance-related features such as managing user accounts, reviewing audit trails, and exporting records. Organisations remain responsible for training personnel on their SOPs and regulatory procedures.
We also provide extensive documentation, including user manuals, validation documentation and method‑development guidance. For broader ecosystem integration, we offer technical services to help configure data exports or API connections to your QMS/MES platforms. For ongoing needs, our technical‑support team is available to answer questions and provide further guidance, ensuring your team remains proficient and confident in maintaining a compliant state.
Simplify your compliance journey with Sepha
Navigating the demands of regulatory compliance requires dependable partners and capable systems. Sepha’s range of non‑destructive leak‑test systems and packaging machines are engineered with the technical controls to support your 21 CFR Part 11 requirements and align with global data‑integrity and cybersecurity expectations. Contact our team to learn more about how our solutions can help you simplify your compliance activities.
Missed the first articles in this series? Read below: