Validation / GLP / Part 11
Solomon Scientific has completed a robust system validation using an outside software testing firm to assure a comprehensive program for Orchesta’s™ initial release. Solomon Scientific has since developed in-house testing capabilities in order to validate future releases internally.
The methods and data from this testing, including SOPs, test scripts, qualification test results, and release data are available to Orchesta customers for the design and implementation of the customer validation effort. Furthermore, Solomon Scientific staff will provide consultation as needed for successful customer validation and installation. Solomon Scientific, as part of its Orchesta business model, shall maintain ongoing software testing and technical support for any further validation assistance which customers might require.
All validation activities are executed and audited according to the requirements of the company’s Quality System and rules for the Software Development Life Cycle.
Part 11
The Orchesta™ software and entire system, including pumps and wireless devices, were designed from the outset to comply with FDA 21 CFR 11 regulating electronic signatures. The practices of each research lab or center combined with the implementation of the software which yield Part 11 compliant systems and data.
Passwords
The System Administrator controls Orchesta’s robust software password system while individual users receive passwords from Orchesta in order to gain read-write access to the software during infusion studies. Other users receive passwords for different levels of access to the study data. For example, study Quality Assurance staff may receive read-only passwords.
E-Signatures and Audit Trails
Each pump user receives a four-digit electronic signature. Any significant user action requires input of the user code at the pump and at the PC. Each action input is stamped with the time and date, and the record is permanently stored in the secure study file which is fully auditable. Record changing requires sufficient password level access, and the change as well as the original value and an explanation for the change are maintained along with the associated electronic signature. Software security measures assure that data records cannot be changed without leaving an audit trail.
GLP
In order for a system to provide GLP-compliant automated infusion, all steps associated with pump infusions must be documented. Deviations from normal infusion procedures also must be identified, explained, time/date stamped, and resolved. Such deviations are documented from the pump using menus and from the PC using either menus or customizable user input. Orchesta™ also comprises data backup, robustness, persistence, and recovery. All GLP-compliant features were developed according to the requirements of the company's Quality System and rules for the Software Development Life Cycle.
The Process
First, the relationship between a particular pump and a unique animal ID must be clearly recorded, and the relationship must persist for all study data. Next, significant pump operations including each pump stop, pump start, and user ID must be recorded. Also, it is vital that the compound infused into an animal is identified (i.e., as either test article or maintenance saline). Orchesta™, using its patent pending Compound Edge Tracking technology, differentiates between the compound which is contained in the syringe and the compound entering the animal’s vasculature (remember, there are dead volumes to consider).
