Compliance & Validation Services
LabAnswer finds the most efficient way to help you build and maintain a compliant laboratory environment by leveraging risk assessments, our existing intellectual property and specific laboratory system expertise.
LabAnswers validation practice addresses the regulated industry’s need to establish documented evidence that provides a high degree of assurance that computerized systems will consistently perform as intended in their operational environment according to predetermined specifications and quality attributes. Our team of experts can help your laboratory satisfy compliance mandates including 21 CFR Part 11.
We have a proven track record and are prepared to assist you in your validation efforts by providing full validation lifecycle services -- ranging from turnkey validation management solutions to the execution of specific validation tasks.
LabAnswer's validation approach gives you "peace of mind" by helping you understand the risks, allowing you to make intelligent business decisions on how to spend your validation dollars. We take the time to understand your strategic business needs and adjust our validation services to meet them in accordance with current regulations. We will customize the validation scope, always explaining to you the associated risks and the criticality and complexity of those risks. We collaborate with you on the approach that best fits your needs and provide you with a service that is both practical and justifiable.
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Laboratory Focus
LabAnswer compliance experts offer years of experience in the Life Sciences industry, including focus in the following laboratories:
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Validation Project Lifecycle |
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Validation is not an event. Validation is incorporated throughout the project lifecycle through inception, elaboration, construction/deployment and support phases. LabAnswer rigorously applies our proprietary Systems Implementation Methodology (SIM) and Systems Development Methodology (SDM) to build first-time quality solutions in a manner that minimizes the cost of validation. |
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Systems Expertise |
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Compliance/Validation Strategic Planning
Allow LabAnswer to partner with you in defining an approach for implementing and supporting your validation efforts company-wide by providing:
- Validation master planning
- Contingency planning
- Vendor audits
- SOP definition and development
- SDLC methodology definition and development
- Support & maintenance
- Planning
- Project Management services
Compliance/Validation Documentation
- Validation plan
- User requirements
- Functional requirements
- SDLC documentation
- Traceability matrix
- SOPs
- Test plan
- IQ/OQ/PQ test protocols
- Training plan
- Training guides
- User guides
- Validation summary report
