A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. QMS is the backbone of every life sciences organization to meet customer and regulatory requirements and improve the effectiveness and efficiency of an organization on a continuous basis.

The QMS comprises of several aspects and procedures that are designed for the assurance of facility, process and/or product quality. A well designed, tailored and implemented QMS empowers the organization to progress efficiently at every phase of the product lifecycle from R&D to Clinical and Commercial operations.

Pharmatek SMEs assist in the design, development and implementation of the robust QMS to ensure all regulatory requirements are fulfils and efficient operation of the organization. Whether you need to build a new QMS or improve an existing one or develop a phase appropriate QMS, our experts work closely with the clients to stay compliant with current regulations, standards and guidelines.

• FDA (21 CFR Parts 210, 211, 820)
• European Guidelines (2003/94/ EC, Eudralex Volume 4)
• ISO ( 9001, 13485, 17025, 15189)
• ICH Q8, Q9 and Q10

Our range of QMS services include.

• Gap Assessment of the QMS, e.g., against 21 CFR 211, EU GMP and ICH Q10
• Medical Device quality management, following ISO13485 and 21 CFR 820
• SOPs Management
• Quality Risk Management
• Change Management
• Deviation management
• Learning Management
• Supplier management
• Implementation of eQMS solutions
• Set up and implementation of CRO, CMO Onboarding processes.