• Too many errors, incidents, discrepancies or deviations requiring investigation and resolution
• Extended Product Release Cycle Times
• Complex and Excessive Documentation
• Documentation that is difficult to read, understand and can train employees effectively
• Project schedules and plans to implement an Electronic Documentation Management System (EDMS), Electronic Batch Record (EBR) / Manufacturing Execution System (MES)
• Harmonizing Documentation within a site or between plant locations

STI provides services to simplify documentation systems and processes with concentration in the cGMP regulated industries, i.e. pharmaceutical, biotech, medical device, and nutraceuticals.

STI's simplification process reduces regulatory exposure, redundancies, and the complexity and time involved in maintaining these systems manually and eases the migration to the electronic environment, i.e.

• Electronic Batch Record (EBR) / Manufacturing Execution Systems (MES)
• Electronic Document Management Systems (EDMS)
• Corrective Action and Preventive Action (CAPA)
• Laboratory Information Management Systems (LIMS)

In other words, simplifying and streamlining the documentation before automating the process.

The impact of STI's redesign process provides visible, tangible results to its clients leaving an “easy to maintain” process, ensuring ease of transition to new and/or enhanced business systems.