Quality System Software Solutions – Implement Electronic Signatures for Improved Performance

We support clients throughout the process of automating business processes through off-the-shelf or custom quality system software solutions.

We assist in the configuration, validation (including Part 11 requirements), and implementation of custom and off-the-shelf software systems.

Our team will fully support your custom quality system software solutions during development, configuration, validation, implementation, and ongoing maintenance.

Our Quality System Software Solutions include:

  • Assistance defining system requirements and selection criteria
  • Preparation of Requests for Proposals & Quotes (RFP & RFQ)
  • Develop functional and technical specifications for software applications
  • Configuration of software applications to meet individual business processes
  • Support in writing test scripts for validation
    (including test scripts for Part 11)
  • Facilitate software validation (IQ, OQ, PQ) with client teams
  • Assist migration efforts
  • Support any integration of 3rd party software

Implementing an electronic quality management system can have huge performance benefits for your company. If implemented and maintained properly, you can gain efficiencies in almost every area of your company. Implementing electronic workflow on the manufacturing floor can also reduce a host of regulatory risks that are inherent in paper-based systems.

Are you ready to make the investment and take a giant leap forward to become more productive than you ever thought you could be? Our experts will help you evaluate which solution is right for you and will help you achieve a successful implementation within a reasonable timeframe.

Do you have unique requirements that cannot be satisfied by off-the-shelf solutions? Our experts can create a custom quality system software solutions to fit your unique needs and we will fully validate and support that solution for the long term. Our team has a proven track record for designing, validating, and implementing custom Part 11 compliant quality system software solutions. We have also configured and implemented most of the off-the-shelf systems that can be implemented in medical device companies.

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