Download our Free Quality Culture Poster
Producing high-quality drugs is the top priority for pharmaceutical manufacturers because it saves lives, enhances wellness, and often results in quality culture privileges from the FDA. View RCA’s poster from the 2016 Parenteral Drug Association (PDA) Annual Meeting on how to effectively build a quality-focused company culture.
About RCA’s Quality Assurance Services
Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous QA improvement, aligning with your QA engineering team and business needs. Quality is something our software quality assurance consultants are experts at with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your quality engineering team.
- Quality Assurance Consultants – Interim Management, staff augmentation or outsourcing quality and regulatory management has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the lifecycle of the organization.
- QA Audit – Virtual gap assessments can assist your team in advance for an upcoming QA inspection by a notified body. These proactive organizations turn to RCA for outsourcing Ex-FDA experts who can describe exactly what a notified body looks for.
- Quality Assurance in Software Testing – Cybersecurity is becoming more essential to our industry based on updated FDA cybersecurity guidance. Pharmaceutical manufacturers partner with RCA for their cybersecurity FDA strategy and how to stay ahead of hackers.
Early in a company’s lifecycle, strategic leadership is needed for product filings, regulatory pathway, manufacturing setup, and quality management systems creation. As the company matures, QA planning often transitions to a continuous improvement stage.
- Total Quality Assurance
- Quality Assurance Methodologies
- QA Procedures
- Project QA
- Product QA
- Supplier QA
- Digital QA
- Agile QA
Outsourcing QA management can often provide a more strategic perspective when you’re challenged across changing quality control in engineering teams. Our pharmaceutical quality assurance experts bring a wealth of quality assurance management needed to help you cut cost via unique QA methodologies.
- Quality Control Audit
- QA Procedures
- QA Reporting
- QA Responsibility
- SOP Quality Control
- QA Best Practices
- QA Programmer
- QA Project Manager
- QA Software Tester
- SQA Tester
- Software QA Analyst
- Software Quality Analyst
- QA Testing Services
- Standard Quality Control
- Quality Control Tester
- Quality Assurance Analyst
- Data Quality Analyst
- Software QA Outsourcing
- Agile Quality Management
- Web Quality Assurance
- Software Quality Control
- Quality System Automation Using Software
- Quality Systems Implementation
- Quality System Remediation / Improvement
- Quality Control Procedures
- Computerized System Validation Standard Operating Procedure (SOP) – Our computer validation experts and software engineers have extensive experience with the GAMP5 validation model to ensure that you have the appropriate level of documentation.
- Risk Management ICH Q9 – We can provide you with the staff and tools needed to implement or remediate your quality systems to current industry standards and train your personnel to manage it.
- Corrective and Preventive Action (CAPA) and Complaint Systems – We manage implementation and remediation of CAPA systems and Complaint Handling Systems.
- 21 CFR Part 210 and 211
- Quality Control Assurance
- EU Good Manufacturing Practice (GMP)
- Quality Assurance Best Practices
- QA Testing Process
- Performing Quality Control
- QA Workflow
- Quality Culture Guidelines
- QA process
- QA Tester
- QA Analyst
- QA Management
- Laboratory Support
- SOP Development
- Method Transfer
- Method Validation
- Data QA
Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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.