QC Laboratory Compliance

1LIMS is designed with compliance in mind, providing features that help labs meet regulatory standards easily. The system automatically records every action in an audit trail, enabling full traceability of who did what and when. It also supports version control on all lab data (methods, specifications, results) and enforces approval workflows so that changes or results are reviewed by authorized personnel. Together, these features help laboratories navigate audits and inspections with confidence, as all required records and signatures are captured and readily available.

1LIMS creates a comprehensive audit trail for all your laboratory data and activities. Every change made in the system—be it an edit to a test result, an update to a test plan, or a user login—is automatically logged with a timestamp and user ID. This means you can retrieve the full history of any sample, test, or record at any time, showing exactly what was changed, by whom, and when. Such complete traceability simplifies compliance reporting and helps quickly answer any questions during regulatory audits.

Yes. 1LIMS supports electronic signatures and customizable approval workflows to ensure only authorized individuals can approve critical data. For example, you can set up the system so that lab managers or quality assurance officers must review and electronically sign off on test results or changes to master data before they are finalized. These e-signatures are captured in the audit trail and meet regulatory requirements (like FDA 21 CFR Part 11), ensuring that your lab’s approval processes are both streamlined and compliant.

Yes, 1LIMS is built to help laboratories comply with major industry regulations. It provides features for 21 CFR Part 11 compliance such as secure, time-stamped electronic records, permission-controlled access, and electronic signatures. It also aligns with standards like ISO 17025 by enforcing strict document control, method standardization, and traceability of results. With audit trails, role-based access control, and data integrity safeguards in place, 1LIMS makes it much easier for labs to meet requirements of GLP, GMP, ISO standards, and other regulatory frameworks.

1LIMS ensures data integrity by controlling and monitoring every modification to lab data. It uses role-based access controls to restrict who can edit or delete information, and every change is versioned so you never lose historical data. In terms of security, 1LIMS is hosted on a secure cloud infrastructure with encryption, and it regularly backs up data to prevent loss. The platform also implements security best practices like authentication protocols and user access logs, so labs can trust that their data is protected and remains unaltered except by authorized actions.

Version control in 1LIMS means that whenever a critical piece of data (such as a test method, specification, or SOP) is updated, the system keeps a record of the old version and notes the change. This is important for compliance because it provides a transparent history of how your procedures or data have evolved. If an auditor asks when a method was changed or who approved a new specification, 1LIMS can show the previous versions and the exact timeline of modifications, ensuring nothing is lost or unaccounted for.

1LIMS simplifies audits by organizing all compliance-related information in one place and making it easily searchable. With features like automated audit trails, built-in reports, and centralized documentation, staff can quickly retrieve evidence of compliance (such as test records, change logs, or training records) during an inspection. Because every action and result in the system is traceable and time-stamped, auditors can be given a clear view of your lab’s operations without digging through paper logs. This readiness can significantly reduce the stress and time associated with external audits.