But it also needs to do all this in such a way that is lightweight, flexible and realistic for your business to implement. Consider the weightier eQMS systems on the market designed for large scale pharma firms, the amount of time they take to set up, the weeks and months involved in ...
OOS (Out of Specification) refers to a product that does not meet the established specifications as expected. OOS investigation determines the actual cause of the results.
BlazeLIMS is working equally well in QC, regulatory, R&D, contract and specialty laboratories, across a wide range of industries including process, pharma, films, electronics, food and beverage, etc. What Does BlazeLIMS Cost? First of all, BlazeLIMS pricing for both software and services is ...
In the context of your life sciences (be it a Medical Device, Pharmaceutical, Biotechnology, Cell & Gene industry), a Batch Record is defined as the documentation that will provide the entire manufacturing history of every batch of product that you manufacture. Every Batch Record is of the utm...
metrics intended to measure quality culture: Measuring Senior Management Engagement, CAPA Effectiveness, and Process Capability/Performance. This version of the quality metrics guidance generated 83 comments from industry, with a number of these focusing on the practicality of submitting the re...
Today's leading pharma companies rely on enterprise quality management systems (EQMS) to manage the myriad of standard quality processes--both in-house and outsourced--such as audit, corrective and preventive action (CAPA), deviation, and out of specification/out of trend (00S/00T). Outsourcing...