Our industry experienced GLP Validation Specialists have the necessary expertise to customize and streamline your validation program, saving you time and reducing costs associated with computer systems validation, enabling you to achieve your research goals sooner.
Validation Solutions Package Components:
- 21 CFR Part 11 & GLP Consultation
- Validation Plan & Report
- System User Requirements Specification (URS)
- System Standard Operating Procedures (SOPs)
- Installation & Qualification of Ponemah Data Security Option (DSO)
- Installation Qualification (IQ) documents
- Operational Qualification (OQ) documents
- Performance Qualification (PQ) documents
- User Acceptance & Stress Testing (UAT) design & assistance
- Traceability Matrix
- Supporting Ponemah electronic test files
Additional validation service options available. Please contact us today!
Qualification Services (QSP) by DSI
DSI’s Qualification Services offer non-GLP customers the peace of mind of consistent system operation. Utilizing the same quality documents and qualification processes used in DSI’s validation products, the QSP provides each of your Ponemah systems with a certificate of Installation and Operational Qualification (IOQ) and the test documents used to qualify the system. System Qualification can be performed at DSI prior to shipping or at your location by our experienced Validation/Qualification Specialists.
The Benefits of System Qualification:
- Assures correct and consistent system operation
- Helps you maintain your quality processes
- Provides proof of system installation and operation for auditors
- Less system down time, fewer calls to Technical Support.
- Easier to reliably implement and manage software changes
Note: DSI Qualification Services (QSPs) do not offer compliance with GLP or FDA regulations. If your organization is required to validate systems for compliance with FDA’s 21 CFR Part 11 or other regulations please enquire about DSI’s Validation services.
Contact Scientific Services today for more information.