Providing Assurance to Fulfill Predetermined Specifications
Our Consultants have a strong track record of successfully installing, enhancing, and maintaining routine and complex systems, processes, and programs in Regulatory Affairs, Quality and Compliance Systems, and Validation Strategies.
Pursuant to our defined goals, our Consultants work closely with assigned clients and routinely interface with various regulatory authorities to ensure the successful launch and maintenance of products by each client.
By enabling our clients to manage the fine but critical details of their projects wisely, we play a major part towards continuously raising the quality of their operations to new heights of excellence.
We encourage you to make us your partner in a mutually rewarding relationship.
Consider the Following Thoughts on Validation Strategies:
Definition: Validation is the establishment of documented evidence that provides a high degree of assurance that a given process will consistently produce output that meets its pre-determined specifications (acceptance criteria) and Quality characteristics.”
Learn the Benefits of:
- A Validation Master Plan
- Establishing Through Experimentation the Acceptable Range for Each Parameter Characteristic. [for Example, if the Parameter Is “heat”, Set an Acceptable Range for the “temperature” Reading.]
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Computer Systems Validation (CSV)
Understand the Need for:
- Writing a Validation Protocol.
- A Reviewer(s) of the Validation Protocol.
- An Approver(s) of the Validation Protocol.
- Writing a Validation Protocol.
- A Reviewer(s) of the Validation Protocol.
- An Approver(s) of the Validation Protocol.
How About Scenarios for:
- Retrospective Validation?
- Concurrent Validation?
- Prospective Validation?
- At Scopus Consulting, LLC, we teach our clients to ‘trust but verify’ by carefully selecting and employing the appropriate strategies.