What We Do
Turnkey System Implementations
We are a full-service turnkey operation. From data gathering, business analysis to system implementation, processes, and product development, our trained professionals are available to help you create a more efficient and effective operation.
Offshore Development, Testing & Validation
To help your organization embrace new innovations in your industry, we have an offshore model that allows us to utilize resources for development, testing, and validation outside of your company. This allows you to take advantage of new talent with industry experience to keep your company growing and thriving.
Through our outsourcing capabilities, we can ensure security of your company's proprietary formulas and processes. We seek to provide you with the resources to enhance your company and your processes through outside talent that you can't find anywhere else.
Computer System Validation (CSV)
In the United States, regulated companies are required by the FDA to perform validation of any computerized systems that work in coordination with the production of highly regulated products, including medical devices, blood components, infant formulas, biologicals, and pharmaceuticals.
Computer System Validation aka CSV ensures that all new and existing computer systems are suitable for their intended purposes and produce trustworthy results that enable you to meet your compliance obligations, in addition to producing a safe and effective product.
Our team at Riva Scientific can help ensure that your computerized systems meet the specific requirements for your industry as well as help you set up processes moving forward to maintain those requirements.
Project Management
Effective project management is essential to any new task that you take on. Our team members have the organization skills necessary to take any project from start to finish.
We understand the need for proper planning and documentation, how to motivate team members, and how to achieve the specific goals of any given project.
Business Analysis and Process Development
Our experienced business analysts assist various business functions to identify inefficiencies in existing processes, assist in defining new business processes and requirements to develop optimal solutions.
If you are planning to implement a new system or processes, or refine existing ones, consulting a capable business analyst with domain expertise from Riva will help leapfrog such efforts and achieve desired results.
GxP Compliant Applications for Labs, Manufacturing and Quality Systems
We bring vast experience in implementing systems to manage lab inventory and processes (LIMS), lab automation, experiment lifecycle (ELN), Management of Quality records (QMS), Document management (DMS), Learning Management (LMS), and many more.
We have partnered with product vendors and our clients to design, configure, validate and deploy solutions meeting business and regulatory requirements such as cGMP, 21 CFR Part 11, Annex 11.
For startups, we assist in developing a strategic roadmap, defining processes, and selecting products that integrate your company’s vision for a paperless, automated, transparent, and compliant work environment.
Compliance Gap Analysis and Remediation Strategies
We assess your company’s existing procedures, systems, and documents to ensure that they meet local, state, and federal standards to identify any gaps in your compliance program. From there, we’ll help you create remediation strategies to mitigate any risks that these gaps could bring to your organization.
System Risk Assessment and Criticality Analysis
Assessment of risks associated with utilization of a system or processes interacting in the development, testing, or manufacturing of pharmaceuticals, medical devices, biologics is required to ensure adequate measures are put in place to be compliant with applicable cGXP regulations.
Our team of expert consultants can conduct system risk assessments to identify potential risks, assign criticality scores on key measures and come up with a plan to mitigate prioritized risks.
Development of Policies, Standard Operating Procedures and Technical Writing
To keep operations running smoothly, maintain safety and compliance, and ensure that your organization is in good standing in the case of an audit, it is crucial that you have standardized policies and procedures in place.
The consultants at Riva Scientific can help you develop these policies and procedures in accordance with the regulations of your industry.
Not just any writer will fit the bill for highly regulated industries like life sciences, biotechnology, and information technology.
Our technical writers are familiar with the territory and can help you in just about any writing capacity, from documenting processes to writing consumer instructions and descriptions.
What To Expect
It all starts with an initial assessment. Our team will meet with you to get an understanding of your business and the projects with which you need assistance. This will help us to get a better idea of where we need to start–whether you are at the beginning of a project, somewhere in the middle, or just need help filling any compliance gaps.
After our initial meeting, we’ll conduct an analysis of the project, business, or process to help identify the tasks that we need to complete moving forward. This may involve risk assessments, vendor evaluations, and other audits.
After our assessments are complete, we will outline the entire scope of the project to determine the best process to complete or maintain your goals. This is where we’ll determine if the services you need can be done on-site or outsourced and identify all of the parts that are needed to take this project to completion.
Interested in any of our services?
We would love to hear from you!
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