FDA 21 CFR Part 11 Compliance for Pharmaceutical and Medical Devices
Finding a materials testing software that truly contains features to support an organization’s compliance to the FDA 21 CFR Part 11 regulation has long been a problem in the medical industry where data integrity is key to safe, traceable materials testing of pharmaceuticals and medical devices. Lloyd Instruments, a brand under AMETEK STC, now offers advanced technical controls that enable its users to ensure data integrity.

Full-Service Solution Ensures Adherence
With the launch of the NexygenPlus 4.1 materials testing software and its new, advanced security module, Lloyd Instruments offers a complete materials testing solution integrated into an organization's Active Directory (AD) including IQ/OQ and test result verification. Developed under ISO9001 procedures, Lloyd Instruments partners with users to review the technical controls within NexygenPlus 4.1 and how they can assist an organization to be FDA 21 CFR Part 11 compliant.

NexygenPlus 4.1 – As Easy as it Gets
Like its predecessor, the powerful Windows-based NexygenPlus 4.1 software holds a vast library of pre-defined test setups for a wide range of applications, such as syringe testing, needle bend, break loose force, and glide force, which makes the software quick and easy to operate. The user can also choose to create custom multi-stage tests for more complex or unique test demands.

However, the primary new feature that makes NexygenPlus 4.1 the ideal solution for organizations in need of adherence to FDA 21 CFR Part 11, is the powerful security and data audit tracking module specially developed with the pharmaceutical and medical device industries in mind.

Electronic Signatures and Audit Trail Provides Maximum Traceability
NexygenPlus 4.1 integrates with Active Directory (AD) to utilize an organization’s user management system and thereby complying with an organization’s existing user management policies. Electronic signatures are required and logged for test method approval, test run approval, and 2nd reviewer approval. With the new NexygenPlus 4.1, audit trail and event log metadata is stored in a secure SQL database including old and new values, user management info, timestamp, and timezone. An optional IQ/OQ package is available to include test result calculation verification and a certificate is issued on completion.

A Flexible Software
NexygenPlus 4.1 interacts with Excel and Word and offers its user the possibility of automatically transferring test results directly to the organizations’ own templates without user intervention. Live graphs are available during testing, SPC data is continuously monitored, and built-in export utilities assist direct connection to LIMS systems.

A Complete Solution 
NexygenPlus 4.1 can be purchased as an upgrade to older NexygenPlus versions, or as part of a complete solution including IQ/OQ and result calculation verification. To learn more about the solutions offered, contact Lloyd Instruments or visit www.ametektest.com.
Material testingPharmaceutical and medical testing

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