Electronic Signatures Alone Don’t Solve the Challenges Faced by Medical Device Quality Professionals

While the adoption of electronic signatures has streamlined document management for medical device quality professionals, it does not fully address the intricate challenges they face. Electronic signatures tools and add ons, compliant with standards such as 21 CFR Part 11 and Annex 11, ensure that digital records can be trusted like their paper counterparts. However, when it comes to the stringent requirements of ISO 13485, specifically sections 4.2.4 and 4.2.5, the management of quality records and document control needs to go beyond just digitization.

ISO 13485's section 4.2.4 mandates the control of documents to ensure they remain legible, readily identifiable, and accessible to authorized personnel. Meanwhile, section 4.2.5 calls for establishing documented procedures to define the controls needed for records, including their identification, storage, and retrieval. These requirements reflect the need for a comprehensive approach to documentation management that ensures integrity, security, and traceability throughout the lifecycle of a medical device.

While electronic signature solutions provide a means to authenticate users and protect documents, they do not inherently offer the extensive document control, audit trails, or version management needed to meet these stringent ISO requirements. This is where eQMS (Electronic Quality Management Systems) comes into play.

An eQMS does more than store documents or authenticate signatures—it offers?real-time tracking, version control, automated workflows, and audit trails, ensuring that documents are always up to date-, easily accessible, and compliant with regulatory requirements. These systems facilitate collaboration across departments, reducing the risk of errors, omissions, or outdated information being used in critical processes.

While electronic signatures are a crucial piece of the puzzle, it's the broader capabilities of eQMS systems that make the real difference. By providing comprehensive oversight and control over documentation, eQMS systems empower medical device quality professionals to meet regulatory requirements with greater ease, efficiency, and confidence.

Orcanos Orcanos stands out as an "all-in-one" solution that goes far beyond the capabilities of standalone electronic signature tools. While electronic signatures are an essential component for ensuring regulatory compliance, Orcanos integrates this feature into a comprehensive eQMS platform that addresses all the critical gaps. By combining document control, risk management, CAPA (Corrective and Preventive Actions), and audit trails, Orcanos provides a unified environment where quality professionals can seamlessly manage every aspect of compliance. The platform ensures that electronic records are not only signed but also properly stored, versioned, and accessible to the right people at the right time. Orcanos' robust workflows, traceability, and real-time reporting ensure that medical device companies can maintain full visibility and control over their quality processes, meeting the stringent requirements of ISO 13485 and other regulatory standards with confidence. In short, Orcanos delivers a holistic solution, integrating every element required to manage quality in the medical device industry, something that standalone electronic signature solutions simply cannot achieve.

Written by Rami Azulay