Regulatory Compliance

Labii brings the controls, evidence, and operating documents needed for regulated laboratory work into one connected environment. Trace every meaningful change, retain records safely, approve work with electronic signatures, and support validation with qualification, software lifecycle, continuity, recovery, and security documentation. These capabilities help organizations configure workflows around their own quality system and regulatory obligations.

Activity history records who made a change, when it occurred, and what changed. Before-and-after values make the sequence of edits easier to investigate, review, and explain during quality reviews or audits.

Labii automatically assigns a unique identifier to each record. Stable IDs reduce ambiguity, support reliable references across workflows and reports, and help teams retrieve the correct evidence during reviews and investigations.

Authorized users can apply an electronic signature to a record with signer and time information captured as part of the approval. Once signed, the document is locked against ordinary editing so the approved state remains stable and traceable.

Labii capabilities can support an organization's approach to EU GMP Annex 11 for computerized systems, including lifecycle controls, data integrity, audit trails, access management, electronic signatures, backup, archiving, and business continuity. The regulated organization remains responsible for risk assessment, validation, procedures, and oversight within its GMP environment.

Labii's Information Security Policy establishes the principles used to manage confidentiality, integrity, and availability. It defines responsibilities and a consistent framework for access control, risk management, incident handling, personnel practices, and protection of information assets.

Labii's Business Continuity Plan defines how essential services and responsibilities are maintained during a disruption. Documented roles, communication paths, alternative arrangements, and testing help the organization respond in a coordinated way and reduce operational interruption.

Labii's Quality Manual describes the quality-management framework behind service delivery. It connects policies, responsibilities, document control, change management, corrective actions, training, reviews, and continual improvement so customers can understand how quality practices fit together.

Labii uses a documented software development life cycle across planning, design, implementation, review, testing, release, and maintenance. Requirements, change control, peer review, dependency management, automated tests, and release checks provide traceable evidence for a repeatable quality process.