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SOP Templates

Clear guidance on SOP Templates

We offer GCP/GMP/GLP SOPs singly or grouped, for U.S. FDA-regulated industries: Pharmaceutical, Biotechnology, Medical Device, and Diagnostics.

 

How we do it

Our Standard Operating Procedures (SOPs) provide basic templates for U.S. FDA-regulated industries including Pharmaceutical, Biotechnology, Medical Device and Diagnostics. They can be customized by your personnel to meet your company's specialized needs.  View sample lists.

SOPs are available for:

  • Production and Process Control 
  • Adverse Event Report 
  • Document Control 
  • Training
  • Quality Manuals (i.e., GCP, GLP, GMP, ISO 13485, ISO 9001)
  • Validation templates -- IQ/OQ/PQ, software
  • Risk Management File templates (ISO 14971:2007)
  • Other

*All SOPs are designed to meet U.S. FDA requirements under 21 CFR Parts 11, 210-211, 820, and ISO 9001, 13485, and 14971.

Need a quote? E-mail us at SOPs@Safis-Solutions.com or by phone at (317) 777-6200.