Customers include:
- Bayer Corporation
- Boston Scientific
- OSI (Eyetech)
- Ligand Pharmaceuticals
- Medtronic
- Merck
- Procter and Gamble
- Salix
These customers require that any computer system, including LIMS, can be validated for use under FDA regulations and guidelines. They must control access to every screen and function and must never allow change to data without an audit trail of who made the change, when it was made and why it was made. The original value of the data before the change must be saved for inspection and reporting. The system must support their compliance with 21 CFR Part 11, including providing for electronic signatures where a paper one would be required.
LIMS for these customers must also provide the ability to set up and manage stability studies on raw materials, intermediates and final products. LIMS must also manage and report training records of staff, calibration and maintenance schedules for instruments and equipment, as well as numbering and tracking of printed reports. Matrix can provide all of these requirements.
