QC Planning and Scheduling Software
Life Sciences companies include Pharmaceutical, Contract Development and Manufacturing Organization (CDMO), Biotechnology, Contract Research Organization (CRO) and Biosimilars continue to operate in a highly competitive environment. The Quality Control (QC) laboratory in a pharmaceutical company plays a critical role in the testing of Raw Materials, Stability, In-process and FG Samples. QC Analysts from different sections analyze incoming samples of different kinds. These include Finished Goods (FG), in-process products, stability samples, and environmental samples. Analysts may also be required to analyze raw materials.
In organizations with diversified drug products, the number of samples to be tested per week will range from 150 – 400 Samples and each sample must go through a minimum of 6 tests. In such a scenario it is a challenge to prioritize the samples and assign equipment like HPLC/GC to the QC Analyst manually.
HOD’s of QC Labs are under steady pressure to improve the lab operations in order to meet the Sample TAT (Turn Around Time). The equipment used in the Pharmaceutical and Biotech product testing are highly sophisticated, extremely sensitive, and very expensive. Maximizing both staff (Laboratory technicians and managers) time and machine time is essential in the QC lab to address the problems of varying demands and to maximize resource efficiency.
Consequently, Planners/Managers are finding a way to move towards lean QC lab by improving their processes, improving effective utilization of resources, reducing lead times, and at the same time, increasing reliability by accelerating authorization processes for compliance. This affects both production and batch release.
A good Quality Control Planning describes how an organization will achieve its quality goals by specifying the quality assurance and control activities which are performed as part of daily lab operations