Protocol Development - industry average costs

• How much does it cost you to create a validation protocol (DQ, IQ, OQ or PQ/PV)?

• Industry averages are $1,000 - $4,000.

• A protocol with 5 -10 tests takes about 40 hours to create from scratch, so typical costs range from:
  
  

  -	$1,000 - $3,000 for an in-house validation professional (based  on $50K-$70K salary, with or without burdened labor rates).

  -	to $4,000 for an external consultant (at $100 per hour).

• And you need to double these numbers to get the total cost:

  -	$2,000 - $8,000 for a typical IQ/OQ pair.

Benefits of the cGMP Systems approach

• Lower costs for creating protocols:

  -	Each of our Guidelines (average price $3,500) can be used to create any number of customized protocols (which typically cost $2,000 - $8,000 for just one IQ/OQ pair).

• Faster Validation reviews - hence lower costs:

  -	All protocols are created in a standard format from a consistent suite of Guidelines.

• Faster path to standardization, by using our Guidelines as an industry-tested starting point:

  -	Without these, if your company is small, you may not have the resources to create standards from scratch.
  -	Or, if your company is large, your standardization efforts may  often get bogged down in committees.

• Lower training costs.