LIMS Validation
CSols’ Validation Practice is comprised of highly skilled Scientists, Information Technologists and Regulatory Experts. This multi-disciplinary Consulting Team speaks the language of both your Business and Laboratory Partners. This means they will quickly understand your computer systems, relevant applications, business processes, and workflow. Hence, they develop higher quality Validation Plans, Documentation, and Test Scripts with less time and effort than Generic Validation Consultants expend.
Furthermore, CSols Validation Consultants also understand the real-world practices of regulatory bodies such as the FDA, EPA and NRC. Therefore, CSols can effectively and efficiently help you plan and implement a fully compliant, defendable Laboratory Informatics environment.
Our unique Validation Services portfolio combines
the experience of our Industry Experts with CSols’ Methodology, resulting
from ever-evolving Best Practices. This proven combination has delivered
peace-of-mind for our clients.
With the ever-growing government-mandated
Compliance and Regulatory Requirements,
Computer Systems Validation has become a:
- time consuming,
- costly,
- and potentially risky...
challenge facing companies across multiple
industries, such as Pharmaceuticals, Chemicals, and Energy.
CSols’ approach to any validation project is
centered upon a Risk-Based Approach. We begin your validation project by
developing a Risk-Based Assessment. This Assessment
document prioritizes the features and functions to be tested based upon the
priority and importance of each one and the likelihood and/or impact of
failure. This tiered process for making
decisions based upon the evaluation and prioritization of risks has proven
to provide efficient, effective, and compliant outcomes for companies in the
industries we serve.
Whatever your needs, we can work side-by-side
with your team or assume a leadership role on the project to create the
final product.
The key to an efficient validation process is to
satisfy three activities:
Whether your organization is upgrading or purchasing a new software system, CSols can assist your organization to achieve and maintain cGMP and cGLP compliance, by:
- Creating Validation Project Plans
- Performing Project Management
- Developing a Risk-Based Needs Assessment
- Performing Workflow Analysis
- Performing Vendor Audits
- Creating a Change Control Process
- Assisting in the creation of URS and FRS
- Performing Unit Test design
- Creating IQ / OQ / PQ Protocols
- Creating IQ / OQ / PQ Final Reports
- Oversee the execution of these Protocols
- Developing the Traceability Matrix
- Providing Validation Summary Reports
For additional questions regarding Computer System Validation and to receive more information, contact us, and an Industry Validation Specialist will be glad to help you.