"reduce or eliminate the potential for procedural errors in the workplace"

Batch Records/Device History Records

•   improve "right first time" pass
•   reduce documentation errors
•   reduce review and product release cycle time
•   eliminate redundant data recording and documents

STI's redesign process for production and quality records improves and standardizes the content, format and data flow in the records and other cGMP related documentation. The redesigned record eliminates unnecessary and redundant entries, reduces the potential for error and is easier to complete and review.

Laboratory Forms/Methods

•   replace your laboratory notebooks
•   reduce sample processing time
•   improve productivity of the laboratory personnel

STI's redesign process for laboratory documentation, procedures and processes reduces the time required for the Analyst to document Analytical Method information, record the Analytical Testing results and the time required for data review and approval.

SOPs

• reduce and eliminate the potential for procedural errors in the workplace
• eliminate redundant and unnecessary work practices
• have work instructions that "fit" the process, can be easily used for training, reference and skills enhancement

STI's redesign process streamlines and simplifies procedures making them "user friendly", providing a design and format where instructions are easy to read, use, understand and follow. Where applicable, redesigned procedures clearly state operating specifications, parameters and process control requirements for cGMP's and process control.

Process Development/R&D Documentation

• reduce cycle time for documentation development for R&D/Process Development groups to commercial production

STI's redesign process prepares guidelines and templates for commercial production that can be utilized by R&D/Process Development groups to reduce document development/transfer time to commercial production.