It is easy to confuse the definition of Compliance and Quality as they complement each other. Compliance is about being compliant with specification, policy, standard or law. Also, regulatory compliance for an organization describes the goal to achieve in their efforts to display that they are in conformity with the established regulations, guidelines or specification and government legislation. Quality, on the other hand, is defined as products and services that deliver intended performance consistently based on the customer requirement.
For regulated industries, the regulations and guidelines for Quality System are set forth by the governing bodies such as but not limited to:
- Food and Drug Administration (FDA) – 21 CFR Part 820
- International Organization for Standardization (ISO) – ISO 9001, ISO 13485
- Pharmaceuticals and Medical Devices Agency (PMDA)
- Therapeutic Goods Administration (TGA)
- China Food and Drug Administration (CFDA)
Besides these there are several other governing bodies that define the regulations and guidelines for the industry vertical that they represent.
How do you comply with regulation?
Most of the organization develop their procedures, work instruction, training, etc., based on the regulations that govern their business. That is why having a procedure up to date and following it helps the organization in solidifying the compliance in their respective fields.
Having a well-integrated quality management system in place helps an organization in the compliance arena. Additionally, a well-defined document management system helps to keep track of all the procedures and efficiently control the revision as the regulation changes. Implementing a well defined internal audit management system to pulse check your compliance with procedures, work instructions, standards. Similarly, with nonconformance management system, documenting and trending quality incidents for early signals of major issues. CAPA management to perform effective root cause analysis and put in the action plans to resolve major issues. Sound training management to keep track of training requirements and to ensure that personnel is trained competently to their role.
The Qualityze solutions are designed over years of experience in industry best practices and offer an out-of-the-box functionality to meet requirements defined by regulatory bodies such as FDA, ISO and yours.