Matrix Gemini Pharmaceutical LIMS
Pharmaceutical Manufacturing flows require a layer of complexity built over a general QC LIMS solution. It enables the effective management of batches, from creation to delivery of a final CoA, produced to known and repeatable standards through specification and recipe management and tested in accordance with the defined manufacturing sample management standards.
All the usual sample testing with accept/reject/re-test type gating is still required, but with the added complexity of tracking batches of RP, IP and FP and associating them in such a way that, in the event of a recall or other requirement, you can track exactly what product was created with which raw materials, and vice versa. These are the essential requirements for regulated industries, such as pharmaceutical manufacturing production, which require adherence to regulatory standards, including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, ISO 17025, ISO 9001, and cGxP.
Figure 2. Matrix Gemini Pharmaceutical LIMS
The pre-defined Matrix Gemini Pharmaceutical Manufacturing LIMS System is designed to meet these strict requirements, and yet we know that everyone is different, and every pharmaceutical manufacturing flow will have a curve ball thrown in to catch you out! Matrix Gemini LIMS is built upon a configurable solution that does not require stubs of software code or HTML to be created and merged into the core software. Unique configuration tools enable changes to the workflow, screens, and menus within the starter system without software coding changes.
This enables re-validation of the starter system using delivered IQ and OQ scripts, updated as needed to reflect any further configuration changes made, to be quickly performed. All this saves time, helping get you to your market more quickly and reducing implementation costs. A secondary benefit of this configuration approach is that, since the underlying software remains unchanged by any configuration, upgrades to the software are easier allowing you to take advantage of enhancements and extensions as they become available. Users can make their own changes without invalidating any support agreements (which is not the case with other LIMS vendors) and are able to directly contact our support desk with queries, even sending across particular screens for us to look over if you have a problem. The unique configuration tools in Matrix Gemini LIMS’ provide many advantages to give your Manufacturing LIMS the edge over the competition, drive up efficiency and reduce your lifetime costs.
Matrix Gemini Pharmaceutical LIMS provides a solid foundation for any manufacturing flow, whether you are in automotive, pies, mobile phones, dairy or pharmaceuticals. For further information or a demonstration please contact us.