Data integrity is fundamental to quality control and regulatory compliance in pharmaceutical and biotechnology manufacturing. Every piece of data, from batch records to test results, must remain attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available (ALCOA +). Upholding these attributes is essential for ensuring product quality, patient safety, and regulatory trust. This post explains how Sepha products are engineered to meet these rigorous data-integrity requirements.
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 ensure data integrity?
Sepha products are designed with specific features that align with the principles of 21 CFR Part 11 and ensure the integrity of electronic records. Our systems provide a controlled environment where data is captured and managed securely, preventing unauthorised access or modification. This is accomplished through a multi‑layered approach that combines procedural and technical controls.
Key features include: secure computer-generated audit trails, accurate timestamps for all user and system actions, and robust data-security protocols. Every user interaction, from log-in to test execution or parameter change, is recorded. Each machine operates on a validated Windows IoT Enterprise LTSC platform with a built-in PC, removing the need for external hardware. The system connects to a corporate network for centralised data management, supporting alarm tracking and controlled system shutdown.
The software automatically generates detailed batch reports containing quantitative test results, pass/fail statistics, and alarm or event data. Integration with Active Directory allows the use of corporate credentials for user authentication and electronic signatures during batch close, review, and approval, ensuring that every action is traceable to an individual.
What is an audit trail, and why is it important?
An audit trail is a secure, computer‑generated, time‑stamped electronic record that enables the reconstruction of all the events associated with the creation, modification or deletion of an electronic record. Under 21 CFR Part 11 § 11.10(e), the audit trail must be created automatically and remain protected from alteration by system users. It serves as a complete chronology of activity within the system.
The audit trail is critical for demonstrating data integrity. It provides the transparency and traceability regulators require to confirm that processes were followed correctly and that no data manipulation has occurred. When a deviation or out-of-specification result arises, the audit trail allows investigators to identify who performed each action, when it occurred, and under what context. This capability is fundamental for effective root cause analysis and implementing corrective and preventive actions (CAPA).
Sepha systems record user ID, date, time, and specific actions taken, including alarms or deviations, to ensure full accountability for every record.
How do Sepha products prevent data corruption?
Data corruption poses a significant risk to product quality and patient safety. Sepha products incorporate multiple safeguards that prevent unauthorised or accidental alteration of records. The software is validated to ensure that all functions operate as intended and that results are accurate and consistent. User access controls ensure that only authorised individuals can view or modify data. Each user has a unique login ID and password, and permission levels are assigned according to role. This structure limits operators to defined functions and prevents them from deleting or editing GMP-relevant records. All GMP data is linked to the corresponding audit-trail entries, ensuring that any attempted change is captured and traceable. This linkage protects record authenticity and provides complete accountability for every action performed within the system.
What role do timestamps play in compliance?
Timestamps are a fundamental component of data integrity and 21 CFR Part 11 compliance. They establish a chronological sequence of events, proving that activities were performed in the correct order and documented contemporaneously. Each record, whether a test is started, a result recorded, or an approval logged, is automatically stamped with the date and time. In a compliant system, timestamps must be both accurate and protected from unauthorised change.
Sepha products use a centralised, secure time source that cannot be modified by operators. This control prevents any attempt to backdate events or alter the timing of records. Accurate timestamps enable auditors to verify that tasks were completed as described in SOPs and within required timeframes, such as confirming that a sample was tested promptly after collection. By maintaining synchronisation with industry-standard network time servers, Sepha’s systems ensure consistent, verifiable time accuracy across all connected devices. This capability supports global regulatory expectations and provides confidence that every recorded event reflects the true sequence of manufacturing or testing activities.
How does Sepha ensure data is stored securely?
Data is stored in a password‑protected database that is protected from unauthorised access at the operating‑system level. The system is designed to ensure that GMP-relevant records cannot be deleted or altered to conceal results. Non-GMP data can be managed under defined procedures, while all GMP data is retained in accordance with regulatory requirements.
The system allows for secure export of records and audit trails to human‑readable formats such as PDF/A‑2 for long‑term archiving. Backup and recovery procedures are supported so you can protect against data loss due to system failure or disaster. Additionally, Sepha’s architecture supports seamless integration with enterprise quality‑management systems (QMS) and manufacturing execution systems (MES) via secure data‑exchange protocols, enabling centralised oversight and reporting.
Ensure your compliance with Sepha
Upholding data integrity is a non‑negotiable requirement in the life‑sciences industry. Sepha products deliver the technical controls required to support compliant quality-management processes and to meet the requirements of 21 CFR Part 11. Our non-destructive leak-test and packaging systems help manufacturers maintain secure electronic records, protect data from unauthorised change, and demonstrate consistent regulatory control. To learn more about how Sepha technology can strengthen your data-integrity programme and support compliance objectives, contact our team of experts today.
Missed the first article? Read: What is 21 CFR Part 11 and Why Does It Matter?
