Who would be better than your automated manufacturing solution provider to document the design, development, and complete testing of your equipment? We have the knowledge and expertise to develop the most comprehensive, fully-traceable validation package for your machine; we optimize the efforts by coordinating validation with design, build and testing activities. We can adopt and execute validation activities based on your existing quality program, help you to develop a quality framework, or apply our own proven quality system.
We are fully versed in all aspects of validation related to implementing automated manufacturing solutions and our comprehensive validation offerings are based upon industry standards, regulations, regulatory guidance, and contemporary good practice guidance including those of organizations like the FDA, HPB, ISPE, ASTM, and ANSI.
We are comfortable adopting your validation plan and approach, following our own lean approach, or developing a hybrid in consultation with you. When we have flexibility to use our system, we offer validation packages that take a risk-based, lean approach* to validating your equipment. The risk-based approach focuses validation efforts on only those elements of a manufacturing system that have the potential to adversely impact product quality. This method of validation eliminates redundant testing and reduces the cost, time, and effort required to bring your automated equipment to full production readiness.
*As originally outlined by ISPE and more recently documented in ASTM E2500.
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To better assist our Life Sciences customers, we have grown the validation services offering well beyond that of the equipment-specific installation and operational qualification packages provided by traditional OEMs. In fact, we offer a full spectrum of validation services from the higher-level development of the overall Commissioning and Qualification strategy (C&Q) to the lower-level tactical execution of verification testing.
Commissioning & Qualification Planning
- Standard Operating Procedures (SOPs)
- Master plans
- Project–specific plans
- Product critical-to-quality attributes assessment and rationale
- Product and/or process risk assessment
- System Impact Assessment
- Component Criticality Assessment
- User Requirements Specification
- Functional Specification
- Hardware Design Specification
- Software Design Specification
- Traceability matrix
Test Documentation & Execution
- Factory Acceptance Tests and Site Acceptance Tests
- Installation, Operational, and Performance Qualification
- Deviation investigation and re-test
- Final reports
- Change control