Medical Device LIMS
Medical devices, such as joint implants and stents, are manufactured in a tightly regulated sterile environment to ensure patient safety.
Xybion Medical Device LIMS
A LIMS for regulated manufacturing of medical devices
Xybion Medical Device LIMS is designed specifically for regulated manufacturing industries working to standards such as FDA 21 CFR Part 11, ISO 17025 and cGxP. Developed according to our ISO9001 accredited quality system the solution is supported by comprehensive validation documentation providing a head start to validation activities. Unique graphical configuration tools allow the Medical Device LIMS to be adapted to your specific needs while ensuring that the validated core software remains untouched.
Drive Quality Throughout the Manufacturing Flow
Instantly relate raw materials to final products
Medical Device LIMS drives quality throughout the manufacturing flow by managing and tracking the samples of raw materials, intermediate and final product, ensuring they can be quickly related to the relevant product and batch. Xybion Medical Device LIMS helps you automate and control your sample testing, and record data results, to conform to regulatory requirements.
Key features & benefits of the Medical Device LIMS:
Batch and recipe management to link final products to raw materials and suppliers
Provides complete batch tracking, batch traceability and genealogy
Manage tests performed at each stage of every batch
Allows validation of each production stage
Defined specifications and workflows
Ensures the integrity of the data generated
Automated data approval for in specification results
Management by exception reduces turnaround time
Test to manufacturing specifications
Track manufacturing quality
Customer specific product grading
Maximize the value of manufactured material
Built-in instrument integration, calibration and maintenance and analyst certification
Elimination of transcription errors and improved quality through instrument and personnel capability assurance
Integration with ERP and other corporate systems
Increases organizational efficiency
Built in security, user by user specific access to workflow options and full audit trail
Aids adoption of best practices and regulatory compliance with FDA 21 CFR Part 11, ISO 17025 & cGxP
Environmental Monitoring (EM) module
Environmental testing ensures sterility
The Environmental Monitoring (EM) module simplifies and automates the collecting of samples to monitor critical points around the production facility. Pre-defined testing schedules guide collection of samples from specified locations.
Graphical mapping of test results to sample point locations provides instant visualization of if problems occur. Out of specification test results may be linked to corrective and preventive actions (CAPA) which may be easily logged within the LIMS.
Stability Management Programs
Manage competency, quality cycles and more
The Xybion Medical Device LIMS also manages staff competency, instrument calibration and maintenance, product grading and investigations into quality lapses using CAPA. A stability module enables complex stability management programs to be setup to manage storage and testing of product to derive shelf-life statistics.
Easy to Understand, Simple to Use and Highly Flexible
A brighter future with an efficient Medical Device LIMS
Designed with ‘usability’ at its heart users find the graphical workflow easy to understand, simple to use and highly flexible.
A Xybion Medical Device LIMS helps to eliminate bottlenecks through the QC laboratory, automate and streamline processes, and reduce human error. This results in fewer manufacturing delays and improved profitability for the business, while improved efficiency in the laboratory allows staff resources to add value rather than chase down discrepancies in data and lost sample information.
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Xybion LIMS for manufacturing medical devices
For more detailed information see our Xybion Manufacturing LIMS Brochure
Medical Device Users
Case Studies
See how others use Xybion to manage their quality control testing
Medical Devices
SPD Adopt Xybion LIMS to Manage Pregnancy Studies
Driving an integrated approach to laboratory management Swiss Precision Diagnostics (SPD) is using Xybion LIMS (formerly Matrix Gemini LIMS) to manage volunteer sample collection, laboratory testing and their clinical biobank. The new system streamlines laboratory operating processes and will ensure data is easier to find and use.
Solution: LIMS
Swiss Precision Diagnostics (SPD)
Medical Devices
Matrix LIMS at a Medical Device Manufacturer
Boston Scientific is a major medical device manufacturer that specializes in minimally invasive devices, such as catheters.
Solution: LIMS
Boston Scientific
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