cGMP Consulting
Maintaining data integrity is an important part in ensuring the manufacturing quality of your medical device. 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.
In a time when compromised data has become a common concern among businesses in the life science field, it’s become more critical than ever to maintain healthy practices concerning data storage and release. Medical device companies of all sizes and types need to trust their data’s integrity, which is why thousands of businesses have turned to Regulatory Compliance Associates® for cGMP consulting services.
Data Integrity
With a team of more than 500 industry experts and seasoned veterans of the FDA, we know what it takes to adhere to the standards of global regulatory bodies. We offer the expertise needed to help your business stay within cGMP and preserve your data’s integrity. Our array of training and consulting services will ensure that your customers’ trust in your brand is well-placed.
cGMP Consulting Services
The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These 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:
- cGMP 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 your medical device—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.
Choose RCA as Your QA Auditors
At RCA, we understand just how lasting an impact a compliance crisis can have on your organization. Whether you run a Fortune 100 corporation or a small business looking to overcome the challenges of maintaining cGMP, we’ll take every opportunity to help your company comply with FDA and global regulations.
About Regulatory Compliance Associates
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.
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