Traditional validation in the life sciences industry has long depended on paper-based systems for documentation, review, and approvals. While once effective, these systems are now inefficient due to manual errors, slow approvals, compliance risks, massive volumes of paper records,and high costs.

The first significant steps toward digitization in the life sciences industry began with the introduction of Laboratory Information Management Systems (LIMS) in the late 20th century, followed by Manufacturing Execution Systems (MES). These solutions provided automated methods for data collection, sample tracking, and production oversight, setting the stage for the broader adoption of paperless technologies in validation and compliance management.

The transition to paperless validation in life sciences has been shaped by key regulatory milestones emphasizing electronic records, data integrity, and risk-based approaches. The FDA’s 21 CFR Part 11 (1997) was a pivotal moment, establishing criteria for electronic records and signatures, audit trails, and system validation. This framework allowed organizations to move away from paper-based documentation while ensuring compliance with GMP, GLP, and GCP requirements. In parallel, EudraLex Annex 11 (2011) expanded these principles in Europe, adding requirements for risk- based validation, business continuity, and system security.

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