Validation Is Not an Event, It Is a Continuous Process
Our deep knowledge of your laboratory applications reduces your total cost of validation and implementation. LabAnswer understands the challenges FDA regulated companies face in keeping up-to-date with the on-going changes in the industry, implementing new technologies and maintaining compliant systems. LabAnswer has domain knowledge of regulated industries and the requirements placed upon organizations, such as GxP, GAMP, 21 CFR Part 11, 45 CFR parts, HIPAA, CLIA, CAP, and many others. With over ten years of experience, our validation experts work closely with system implementation teams and software solution vendors to ensure compliance with 21 CFR regulations and completion of the validation process.
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. Our clients rely on us to leverage our multi-system and regulatory experience along with our methodologies to deliver efficient solutions that support their program objectives, that are practical from a business perspective, and that are defensible to regulatory agencies.
Our validation consultants are not your typical technical writers who are only adept at writing technical documentation. Our validation specialists understand the science and are very familiar with the systems they are validating. They can maximize the value of your compliance investment by testing to the level of risk and cost of the risk to the organization. In other words, some requirements will require a more thorough test to ensure that the system meets the requirement and our consultants are skilled at recommending the appropriate level to test to.
Systems Implementation Methodology
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. LabAnswer can help you determine that procedures and processes are in place for ongoing system validation and change control activities.
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
- Project management services