BLUE works within the regulations of a cGMP compliant environment.
Since 2002, BLUE has provided validated services to regulated clients. A validated BLUE implementation adheres to standard implementation operating procedures that pre-define the step-by-step processes for planning, designing, building, testing, training, and deployment. BLUE also offers a validation package of templates, modeled after the GAMP (Good Automated Manufacturing Practice) Guide for Validation of Automated Systems to yield properly documented evidence and traceability.
Our implementation procedures and validation package meet the utmost standards within highly regulated and validated environments and are fully supported by our Quality Management System – helping you efficiently maintain compliance with both internal policies and government regulations.
BLUE delivers validation services.
BLUE’s validation services provide a high degree of assurance BLUE will function according to the requirements you set forth. These services begin with a Validation Master Plan, which outlines the principles involved in BLUE’s qualification and specifications for how validation will be achieved and maintained.
BLUE achieves traceability.
BLUE maintains traceability through:
- User Requirements Specification
- Functional Design Specification
- User Acceptance Testing
During the planning phase of an implementation, we work with you to clearly define roles and responsibilities for all aspects of the project. These responsibilities include required activities for system qualification such as:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
As part of deployment, we also work with you to ensure BLUE end users are fully trained and appropriate procedures are in place for operational maintenance and change control.
BLUE ensures compliance.
The end result is a system that enables you to adhere and adapt to FDA, EMEA, and other government regulations regarding audits, system validations, audit trails, electronic signatures and documentation.