Quality Assurance is an intrinsic part of MakroCare process and projects. Our QAU is an independent department reporting to Executive Management. Our Global QA team has highly qualified and experienced auditors with sound knowledge on national and international regulations and guidelines. We have established Global Standard Operating Procedures (GOPs) and Executive Procedures in accordance with the requirements of applicable standards and regulations (ISO:9001, ICH-GCP, US FDA, EMA, HSA and Schedule Y). QA department brings strong experience to achieve customer satisfaction and deliver highest quality standard for all our services.
Our facility is certified with ISO: 9001 (QMS), ISO: 13485 and ISO: 14155 (Medical Device Clinical Investigations).
QA team works closely with both MakroCare Project Management teams and Sponsor’s teams in facilitating quality procedures and compliance. A dedicated QA representative assigns to each project who is the primary contact for all quality assurance issues throughout the life of the study and conducts the audits as per the project quality plan. QAU renders a comprehensive report for all Contracted QA services. QA applies MakroCare’s proprietary framework clinical Total Quality Management (cTQM) to make the quality processes run in excellence which is far wider in its application than just assuring service quality and regulatory compliance.