Quality Systems Now (QSN), founded in 2017, has established itself as a premier consulting service, specializing in delivering intuitive and effective compliance solutions. The company's mission is to assist organizations in regulated industries with their business or compliance transformations, ensuring the successful commercialization of their products. With a team of industry and compliance specialists, QSN is dedicated to supporting businesses through the challenges and complexities of compliance projects.

Expertise and Services

QSN's consultants possess deep expertise and extensive experience in helping clients achieve their compliance goals. The services offered by QSN are comprehensive, including:

• GMP Licensing and ISO Accreditation: Assisting companies in obtaining Good Manufacturing Practice (GMP) licenses and ISO certifications, which are crucial for regulatory compliance and market access.

• Quality Management Systems (QMS) Implementation: Developing and implementing robust QMS tailored to the specific needs of the client, ensuring efficient and effective quality management.

• Greenfield Site Development: Guiding clients in the establishment and commercialization of new sites, ensuring compliance from the ground up.

• Validation and Study Protocols: Crafting detailed validation and study protocols to meet regulatory standards and ensure the reliability of processes and products.

• Quality Risk Management: Conducting comprehensive risk assessments and developing strategies to mitigate potential quality risks.

• Audit Preparation and Remediation: Preparing clients for audits, addressing deficiencies, and ensuring compliance with regulatory requirements.

• Transition to Electronic Systems: Facilitating the shift from hardcopy QMS to electronic systems (eQMS, eDMS), enhancing efficiency and accessibility.

• Process and System Improvements: Implementing continuous improvement initiatives to optimize processes and systems.

• Training and Development: Providing tailored training programs to enhance compliance knowledge and skills within client organizations.

• Plain Language Writing: Teaching teams to write clear and user-friendly documentation, reducing errors and improving productivity.

Leadership: Kathy Walsh

Kathy Walsh, the founder of QSN, brings over 25 years of experience across a range of industries, including pharmaceuticals, medical devices, distribution, wholesaling, biotechnology, medtech testing labs, and R&D companies. Her expertise spans various regulatory frameworks and standards, including:

• Pharmaceuticals: Proficient in Good Manufacturing Practices (GMPs).

• Medical Devices: Specialized in ISO 13485 and ISO 14971.

• Calibration and Testing Laboratories: Skilled in ISO 17025.

• General Quality Management Systems: Experienced with ISO 9001.

Kathy's commitment to promoting Plain Language writing has significantly enhanced productivity and compliance within the companies she has worked with. Her scientific background (PhD), combined with qualifications in project management, training, and technical writing, positions her as a leader in the field.

QSN Academy

QSN Academy, the educational arm of Quality Systems Now, serves as an online training hub designed to support individuals, startups, and companies within regulated industries, as well as those in R&D, high-tech, and manufacturing sectors. The Academy offers expert training and mentoring that is both practical and relevant to everyday work experiences.

Training and Speaking Engagements

Kathy Walsh is available for speaking engagements, including podcasts, interviews, industry training events, and in-house training sessions. She covers a wide range of topics, such as:

• Plain Language Writing: Essential for any industry, particularly those with a STEM foundation.

• Quality Culture in the Therapeutic Industry: Insights based on ISPE and FDA guidance.

• Quality Management and Systems Integration: Strategies for developing and integrating effective quality systems.

• QMS Development: Best practices for establishing robust quality management systems.

• eQMS Implementation: Steps to transition to electronic quality management systems.

• User-Friendly Procedures: Techniques for writing clear and accessible procedures.

• Pharmaceutical Industry Trends: Discussion of current hot topics in the pharmaceutical sector.

• ISO Accreditation Transition: Guidance on achieving and maintaining ISO accreditation.

Quality Systems Now stands out as a leader in providing compliance and quality management solutions. Under Kathy Walsh's leadership, QSN has consistently delivered best-in-class consulting services, enabling companies to navigate the complexities of regulatory compliance and achieve their business objectives. Through its extensive range of services, expert consultancy, and dedicated training programs, QSN continues to drive excellence in quality management across various regulated industries.

For more information about Quality Systems Now, its services, or to connect with Kathy Walsh, visit the QSN website or check out QSN Academy for comprehensive training opportunities.