Apotex Lean Documentation
JK Somers & Associates, Inc.
About the project:
Redesign Quality Management System and associated documentation using LEAN methodologies.
Testimonial:
Hired GxP Solutions as one of the QA lead consultant experts for a Toronto-area pharmaceutical company to redesign their Quality Management System. The lead consultant’s responsibility was to analyze existing quality system element, such as policies, procedures, work instructions, and records, and then re-design and re-write them for technical accuracy, regulatory compliance and ease of use. To do this, the consultant led operator teams to define procedure gaps, unnecessary steps, and usability/accuracy issues. Then the consultant re-designed the process/procedure and associated documents based on expert input, confirmed the re-design with the client team, and confirmed accuracy through on-the-job observation and procedure validation.
I was extremely satisfied by the consultant’s work attitude, process and deliverables. She has excellent written and verbal communication skills, and was always highly motivated, timely and dependable. She enjoyed working with the operators and their managers, and gained their respect and cooperation. I would not hesitate to engage GxP Solutions again. The consultant has a solid understanding of the pharmaceutical industry, including the operational processes, quality and regulatory requirements, and technology. She was eager to investigate what she didn’t know, and readily closed any knowledge gaps throughout the project. The consultant did an excellent job of bringing all those skills and attitudes to my team.
Ken Somers