Maintaining data integrity is an important part in ensuring the manufacturing quality of pharmaceuticals. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.
Regulatory Compliance Associates® Inc. offers offers both training and consulting solutions to meet any organizations needs. Our services include:
Training
- Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
- Annual Good Manufacturing Practice (GMP)
- Investigations
- Corrective Action and Preventive Action (CAPA)
Consulting
- Comprehensive Audits
- Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
- Assistance with Execution of the Remediation Plan
In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.
About RCA
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for 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.
