Possibly more now than ever before, pharmaceutical companies and CMOs are under pressure to ramp up production of anti-viral medication or ready themselves to mass-produce a vaccine. Since Laboratory Information Management Systems (LIMS) implementations can be a significant time investment, how can organizations shorten that timeframe to get up and running with a solution and achieve maximum productivity as soon as possible?
Thermo Fisher Scientific offers a packaged Pharma Solution specifically developed for pharmaceutical manufacturing QA/QC labs, which is designed to accelerate the implementation and validation process. Thermo Scientific™ SampleManager LIMS™ software, installed in half of the world’s top 10 pharmaceutical companies as well as Thermo Fisher Scientific’s own contract manufacturing business, forms the basis of the solution. To get organizations up and running 50% faster than with a regular LIMS, industry-standard capabilities and workflows such as dissolution, retains sample management and stability testing are pre-configured and ready for use. These configurations and data loads avoid customizations in the software, which as well as taking time to develop, can make the system more challenging and costly to maintain in future. A LIMS with fewer customizations is far easier to support and upgrade when the time comes.
SampleManager LIMS software’s Pharma Solution is the only commercial LIMS to include a specially designed module to ease the QC sample review and approval process. The module provides authorized users with a clear overview of all samples awaiting review and leverages review by exception. The Laboratory Execution System (LES) in SampleManager LIMS software drives process integrity by stepping analysts’ through SOPs and providing a complete audit trail of every action.
Any LIMS, commercial or otherwise, will always require validation for use in a regulated environment. There is no such thing as “pre-validated” – every piece of software requires validation and needs to be designed around unique processes and products. The good news is that validation represents the greatest time and cost savings opportunity in LIMS deployment. The Pharma Solution is supplied with documentation, scripts, guidelines and coaching to expedite the process. Organizations can opt for a “risk-based approach” – where an assessment is carried out on the master data and the level of testing required is then agreed based on the perceived risk. Standard OQ scripts, pre-executed OQ scripts for industry-specific features, script templates for OQ and PQ, as well as configured system installation kits and IQ scripts are supplied. Adopting this packaged validation process can reduce OQ time by 90% and PQ by 50%.
For any pharmaceutical organization looking to optimize its supply chain, LIMS is an essential step and a cornerstone of the digital transformation. A proven solution with industry-specific configurations and a validation package delivered with the help of an experienced implementation team will significantly reduce implementation time, enabling drug and vaccine producers to respond quickly to urgent demands.