SOLABS Blog

To never forget where we came from

It all started there in 2005 with our first "real" sale of SOLABS QM version 2.5, formerly known as Alibaba… engineers and names…

That morning, employees at this GMP plant woke up to release 2.8 of SOLABS QM. This version is faster with a highly improved backend infrastructure. Since this release our support desk’s red phone has been pretty quiet!

Our series of upgrades for all clients is completed: Everyone is now using our 5^th major release, SOLABS QM 2.8.

Elements to consider when automating QA processes

Once the time comes for a life sciences organization to automate its QA processes... what should be considered before it begins this initiative?

Identify and prioritize the QA processes that must be automated:

1. CAPA/Change Control;
2. Audit/Complaint/Deviation Report;
3. Etc.

Arguments in favor of life science organizations pursuing automation with regard to management of their quality processes

Ensuring the production and delivery of high quality products is an ongoing issue in the pharmaceutical and medical device manufacturing settings. In order to comply with scrutiny from regulatory agencies as well as consumer expectations, manufacturers in the life sciences industry have established systematic methods to ensure the quality of their manufacturing processes.  An organizations internal quality management system has evolved from a targeted effort to manage individual processes to a recognized need to implement a ‘holistic’ solution that includes management of controlled documents (SOPs, Test Methods, Specifications, etc……), management of Quality Processes (CAPA, Change Control, Complaints, Deviations, etc…..) and Management of Employee Training Records.  The quandary that many life science organizations face is the decision to maintain these Qa processes in a paper-based system, a partially automated system or to implement a fully automated eQMS.

Does enterprise software integration really matter in the life sciences industry?

At the moment, I would say “No, it does not”.

Recently, we have seen a tremendous focus on the introduction of enterprise software integration within the life sciences industry. By definition, enterprise integration for software systems implies that the selected systems should be capable of interacting and, for example, minimize the need to duplicate data entry . In other words, the software integration should facilitate the exchange of information from one system to the other.