We have found that most companies have 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.

Stiemcorp has created Align©, a suite of documents that is easily tailored to meet the customer’s needs as another option.  These documents are based on established validation methodologies, easily understood and communicated and flexible enough to encompass a variety of types of systems. 

Align© Includes: 

     Standard Operating Procedure Checklist Validation Summary Report
     Traceability Matrix
     Performance Qualification
     Operational Qualification
     Installation Qualification
     System Requirements Specification
     Business Requirements Model
     Risk Assessment
     Validation Plan
     Validation Errors Deviations and Test Failures SOP
     Good Documentation Practices SOP
     System Change Control SOP
     System Categorization SOP
     System Life Cycle SOP