Quality Systems Now was founded in 2017 by Kathy Walsh to provide a

best-in-class consulting service that delivers simple and user-friendly compliance solutions. We have continued to help companies and startups in regulated industries in business or compliance transformations to commercialize their product.

We are industry and compliance specialists who understand that any transition or compliance project may be confronting or present unique challenges to your business.

Our consultants will support you and your team, with expert knowledge and experience. We have assisted many sites and companies:

  • Gain their GMP license or ISO accreditation

  • Implement a new QMS

  • Develop requirements and commercialise greenfield sites

  • Develop validation and study protocols

  • Complete quality risk management activities

  • Prepare for their next audit or address audit deficiencies

  • Transition from a hardcopy QMS to an electronic system - eQMS, eDMS etc

  • Implement process and system improvements

  • Transition from a poor QMS to one that is user-friendly and a company asset

  • Roll out training, up-skilling and refresher training to meet compliance requirements

  • Teach your team to write documents in Plain Language that are simple and user-friendly


Kathy has over 25 years’ experience working with pharmaceutical, medical device, distribution & wholesaling, compounding, biotech, medtech testing labs and R&D companies. She specialises:

  • Pharmaceuticals – Good Manufacturing Practices (GMPs)

  • Medical devices – ISO13485 and ISO14971

  • Calibration and testing laboratories – ISO 17025

  • Quality Management Systems (general) – ISO9001

    (STEM related companies).

She is passionate about helping companies adopt Plain Language writing to increase productivity and compliance, and reduce documentation issues, confusion and user errors.

In addition to her scientific qualifications (PhD), Kathy is a qualified project manager, trainer and technical writer.

Connect directly with Kathy:


QSN Academy is an online training hub specifically designed to support individuals, start-ups and companies within regulated industries or those from R&D, high-tech and manufacturing areas. QSN Academy provides expert training and mentoring that is practical and relevant to your day to day work experiences.


Kathy is available for speaking engagements, such as podcasts, interviews,

industry training events or in-house training.

She is able to speak about the following types of topics:

  • Plain Language writing - any industry, but particularly those industries with a STEM foundation

  • Quality culture in therapeutic industry, particularly with respect to ISPE and FDA guidance

  • Quality management and integrating quality systems

  • Developing a QMS

  • Implementing an eQMS (or similar)

  • Writing user-friendly procedures

  • Related pharmaceutical industry hot topics

  • Transitioning to an ISO accreditation