Quality Systems and Processes
UnseenDots has highly experienced team of consultants and advisors with multiple decades successful experience in quality and compliance. Our consultant shall help organizations in setting up various processes in quality, GMP compliance, productivity, delivery, and sustainability.
We are experts in good manufacturing practices (cGMP & GxP’s), ISO management systems, lean six sigma (LSS) processes, total quality management (TQM) and total productive maintenance (TPM) processes.
Our philosophy is “quality is not restricted to the handful people of quality function, but it is reflectance of systems & processes of each function within organization”. We firmly believe and support in creating the culture of excellence within each employee and entire organization.
Our quality mantra is “If it is not demonstrated and documented, it is not done”.
Our team collaborate and support in developing various standard processes and procedures, meeting the quality and regulatory requirements. We are available onsite as well as through online support depending on your needs.
Our Expertise and focus area includes the following:
- Designing, establishing, and validating the systems, processes and procedure (SOP’s) as per your organizational, customer, cGMP & regulatory requirements.
- Training, implementation, mentoring and handholding support to create culture of quality.
- End to end support for validation and qualifications of new or existing facilities and associated documentations like validation master planning, quality manual, site master file, protocol writing, validation execution and report preparation etc.
- Assessing the requirement and scope for digital tool for document management systems and other digital transformation.