21 CFR Part 11

System validation

Regulatory Compliance Associates computer system validation (CSV) experts and software engineers have extensive experience with 21 CFR Part 11 and the GAMP5 validation model to ensure that you have the appropriate level of documentation.

 

CSV is a methodology used to monitor the compliance of information and data integrity that meets regulatory compliance. Regulatory Compliance Associates expert consulting team can help you deliver quality control when replacing manufacturing paper records in regulated industries. We’ll propose strategies that can increase your quality of culture and streamline your reporting.

 

Our list of services includes:

 

  • 21 CFR Part 11 Electronic Records, Electronic Signatures Validation
  • Laboratory System Validation
  • Network Infrastructure Validation
  • Automation and Control Systems Validation
  • Off-the-Shelf and Custom Software Validation

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates (RCA) provides healthcare consulting services to the following industries for the resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue
Privacy Policy