Save Time and Cost

You can create SOP's for your Quality System the quick inexpensive way or the slow expensive way.

The quick inexpensive way is to base your system on generic Quality System SOP's and customize as needed. The slow expensive way is to custom write SOP's. A recent industry wide survey by Path wise, a large consulting and training firm, showed that the majority of respondents take 3-5 days to write, edit, and rewrite a SOP and to create forms. Our SOP's are in Word format, for easy editing. SOP's are complete and ready for use. They are not templates where you fill in the blanks.

Medical device designers would not custom design a component when they could buy a time tested off the shelf inexpensive component (Eg. valve). Software Engineers would not develop custom software when off the shelf programs are available. Why then custom write Quality System SOP's? Why reinvent the wheel?

Supplier Controls Group
This SOP group describes procedures for controlling purchasing and vendor/ contract manufacurer activities including audits and control of changes traveling between company and vendor.

Human Factors Group
These SOP's will allow you to create a compliant program following ISO62366 and the 2016 FDA guidance.

Process Validation Group
These SOP's describe a compliant process validation program from FAT through IQ,OQ and PQ. Validation deviation handling is included.

Risk Management Group
This SOP group contains procedures for a compliant risk management program including Hazard Analysis following ISO14971, FMEA and critical manufacturing operations analysis.

CAPA Group
These SOP's comprise a compliant CAPA program including SOP's for recalls, MDR's and post distribution product monitoring.

Design Controls Group
This SOP group contains procedures that will assure that your product development work is conducted in conformance with FDA/ISO requirements including verification and validation.

Acceptance Activity Group
This group of SOP's describe procedures to control incoming material including control of nonconforming product.

Software Development & Validation Group
This SOP group describes procedures to control the software development and validation process including off the shelf software and 21 CFR part 11 compliance.

Document Controls Group
This SOP group describes procedures for compliant control of documents including laboratory notebooks and partner company documents.

General Quality System Requirements Group
This SOP group describes procedures necessary for a compliant Quality System including how to survive a FDA audit and respond to 483's and warning letters.