Laboratory software for Pharmaceutical QA/QC
The challenges in pharmaceutical quality control lie mainly in achieving and maintaining compliance to regulations such as FDA 21 CFR Part 11, ISO 17025 and GxP, and in ensuring and demonstrating data integrity. It’s essential to know, and more importantly be able to prove, what actions were completed, when, and by whom. The FDA and other regulatory bodies audit laboratories on a regular basis – could you provide them with the data they need to accurately trace any sample from its receipt into the lab, including all the tests, resources used and all the data - including metadata - surrounding that sample?
A complete, connected laboratory solution comprising LIMS (Laboratory Information Management System), LES (Laboratory Execution System) and SDMS (Scientific Data Management System) drives compliance and data integrity by clearly showing the route of data throughout all processes. Demonstrate process integrity through step-by-step electronic SOPs in LES connecting directly to LIMS.
Learn more about our Pharmaceutical LIMS for manufacturing and QA/QC labs, or complete the web form and someone will contact you.
Drive compliance and data integrity with a pre-configured pharma solution
Thermo Scientific SampleManager LIMS, LES and SDMS software’s Pharma Solution is an implementation and validation accelerator which uses industry-standard features, expertise and experience to expedite return on investment and reduce project risk. Half of the world’s top 10 pharmaceutical companies as well as Thermo Fisher Scientific’s own contract manufacturing business rely on SampleManager LIMS, LES and SDMS software to drive quality, compliance and data integrity through their manufacturing QA/QC processes.
The SampleManager LIMS software Pharma Solution:
- Delivers industry-standard capabilities including dissolution, retains sample management and stability testing as well as a unique review module built to expedite review and approval.
- Streamlines operations to ensure consistency, efficiency & productivity across laboratories.
- Expedites implementation and validation, enabling go-live to be achieved 50% faster.