Professional Services

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Full 21 CFR Part 11 compliance for laboratory instruments within 2–4 weeks, leveraging a proven solution that has been successfully validated and deployed across the pharmaceutical industry. 

Instrument software will be upgraded to include: 

• Secure end-user authentication utilizing on-premises LDAP and Windows Active Directory (AD) 
• User group management and role-based access control, with a fully configurable privileges matrix encompassing all critical instrument features and functions
• Electronic signatures (e-signatures) compliant with regulatory requirements 
• Change control functionality to track and manage system and data modifications 
• A comprehensive audit trail that is fully searchable and exportable 

Instrument Vendors: Vendors with non-compliant instrumentation seeking to rapidly enter the pharmaceutical market or expand the use of early-stage R&D instruments into cGMP-regulated environments. 

Pharmaceutical Quality & Development Teams: Organizations aiming to transition entire laboratories—or specific product characterization assays—into cGMP compliance in order to meet FDA regulatory requirements.  

Lumetics provides a local, on-premise LINK server and database instance that interfaces with one or more instruments via a RESTful API. This integration enables instrument software to leverage the full Lumetics LINK 21 CFR Part 11 compliance feature set. 

As part of the implementation, Lumetics supplies: 

• Integration-ready syntax examples written in instrument software source code cover all key compliance elements
• A preconfigured LINK server/database, including a user privileges matrix with five user group levels and their access priviliges to all requisite instrument configuration and operational functions 
• A fully featured, browser-based User Privileges Matrix and Audit Trail interface, which can be launched directly from within the instrument software