2100 Compliance Solution
To achieve compliance, laboratory and production procedures have to be standardized, which is associated with extra costs and workload. To minimize this impact, the Agilent 2100 Compliance Solution provides a tool for reliable quality control. It supports the validation process from start to finish, regardless of whether you are analyzing nucleic acids, proteins or cells. The Agilent 2100 Compliance Solution addresses 21 CFR Part 11 requirements, provides tools for IQ (Installation Qualification) and OQ (Operational Qualification), and offers compliance services.
21 CFR Part 11 compliance – All requirements regarding electronic records and electronic signature are addressed, including data security, integrity and traceability.
Secured environment – No one can acquire or access data without dedicated user account and identification. All actions are tracked and documented with a clear, traceable audit trail and electronic signature.
User identification and roles – Only users with valid user ID and password can log on, access and modify electronic records. Software limits the user functionality, as defined by his role
Workflow management – The executable methods can include a predefined workflow, which defines who will be allowed to execute methods, perform peer reviews, and provide final approval.
Compliance services – Software and hardware IQ and OQ can be purchased at any time. A certified customer engineer will test and verify the functionality of the hardware and software, thereby qualifying the system.
Design Qualification (DQ) - Defines the functional and operational specifications of the 2100 bioanalyzer and ensures it has all necessary functions and performance criteria.
Installation Qualification (IQ) - Ensures that the 2100 bioanalyzer is installed correctly, documenting the completeness of shipping, the operational environment, and the components of the system
Operational Qualification (OQ) - Demonstrates that the 2100 bioanalyzer will function according to its operational specifications.
Performance Qualification (PQ) - Standard Operating Procedures (SOPs) are developed by the customer for PQ.