Case Studies
The following is based on an actual client project of a typical validation by an on-site validation consulting service.
Company "X" validation project consisted of 6 Capillary Electrophoresis Systems, 7 Plate Readers, and 4 Spectrophotometers each utilizing a networked computer and off-the-self software provided by the manufacture of the instrument. A group of 6 Validation Engineers took 12 months to create the necessary templates and documentation, execute testing, and provide summary reports. The billing rate averaged $120.00 per hour for each VE at 40 hours per week for a total cost of $1,497,600. Not included in this total is the cost to the client for utilities, phone, computer, or floor space that the VE used while on-site 40 hours per week.
Company "X"s essential supporting documentation such as a System Life Cycle, Good Documentation Practices, or Validation Deviations, were also found to be insufficient, missing, or in need of revisions. An estimated 40% of the time and budget was spent creating and/or revising templates and documents, making corrections or adding information that was missed during the initial draft. The cost of this effort alone was approximately $599,040.
With Stiemcorp Align© validation solution, not only do you immediately receive a very thorough and industry tested System Life Cycle based on current GAMP 4 standards, and SOPs that detail System Categorization, Good Documentation Practices, System Change Control, and Documenting Validation Errors and Deviations, but also a complete turn-key set of validation document templates and our years of expertise to asses your business needs, develop testing strategy, and complete the validation of your systems to ensure a complete, defensible, and confident validation package.
Company "X" and Stiemcorp could have completed the same validation project in almost half the time with at lease a 40% savings or approximately $880,000. That’s like getting over $600,000 worth of documents free.
You keep the all the supporting documents to for everyday use and you keep the full set of completed executed validation documents for each system.
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