Compliance / Regulations
Compliance / Regulations
What is Compliance?
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. In fact, compliance and quality as they complement each other.
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 (US FDA) – 21 CFR Part 11 • International Organization for Standardization (ISO) – ISO 9001, ISO 17025 • Pharmaceuticals and Medical Devices Agency (PMDA) • Therapeutic Goods Administration (TGA) • MHRA, Euro Annexure 11,15 Besides these there are several other governing bodies that define the regulations and guidelines for the industry vertical that they represent.
Key Points for Compliance
Confirm the specification requirements
It is important that the specification requirements meet the demands on the system and operating environment, and also incorporate the technical elements to satisfy part 11. The documentation of plans procedures, and reports and appropriate review, approval, and management
Effective user management
O-link user administration comprises of the setting of rights group and assignment of rights to users, it enables easy setting of user access rights as well as rights group matched to each user’s required task. Functions such as these achieve effective user administration matched to laboratory operations from managerial tasks to data acquisition operations.
Firm Security
Features functions for setting an audit trail to ensure data reliability and security features include various settings, such as setting the length, expiration date and complexity of passwords for user accounts, setting the lockout function to prevent illegal access, and registering settings for the deletion and alteration of registered users, to enable highly secure system operation.
Audit Trail for achieving change history management
The changes history of method files is managed by the audit trail, application of audit trail to all methods can also be set in security policy settings. This prevents inconsistencies in compliance with regulations.