William Stiemsma, founder of Stiemcorp, began his career in 1984 with a major pharmaceutical manufacturing company where he was responsible for managing and maintaining all aspects of analytical laboratory instrumentation within a Quality Control environment. Since that time he has built and managed a Laboratory Operations Group for a rapidly growing biotech company in Seattle, Washington. He has filled the roles of Validation Engineer and Project Manager for the largest biotech companies in the world and as Quality Assurance Lead for the largest pharmaceuticals and medical device companies at multiple locations.
William began Stiemcorp when he found that most companies had few choices when addressing the needs to bring their systems into GMP compliance. The only options seemed to be:
Build an infrastructure to address compliance and system validation needs. This option is not only time consuming and expensive, the process of recruiting and hiring qualified people can take away from the immediate needs and focus of the company.
Rely on the manufacture provided documentation. Vendor supplied documents typically do not take into account user defined requirements, business process requirements, or risk assessments and lacks evidence that the system can perform an approved sample analysis or that it meets the business process needs.
Bring in an outside consulting company to provide temporary supplemental staffing. The Validation Engineer begins creating documents from information provided by the client and typically spends a large amount of time modifying and revising templates and pre-existing documents to create the necessary documents. Approximately 55% of the project time and money is spent creating documents from scratch or revising document templates that did not quite suit their needs.
William set forth to create a suite of documents that could be easily tailored to meet the customer’s needs as another option. These documents had to be based on established validation methodologies, easily understood and communicated, but thorough enough to encompass a variety of types of systems. He also wanted to include supporting documents that cover subjects such as how to document deviations, how to manage change control, good documentation practices, etc. He wanted this suite of documents to be easily understood and written in such a way as to prompt the user/author for required information that is sometimes overlooked. Re-inventing the process for every client seemed such a waste of time and money as well as frustrating for both the company and the Validation Engineer.
"Even the Stiemcorp Communication Plans and Training Plans are built on the same clean and easy to read SOP format. Stiemcorp practices what they preach."
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