In the life science industry, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device or drug is sent to market. At Regulatory Compliance Associates (RCA), we offer you the quality assurance services you need to monitor these quality processes and ensure quality compliance every step of the way.
RCA’s quality assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
Quality Consulting
The life science industry faces increased challenges as companies navigate the world of QA with fewer personnel. Strategic leadership is necessary for creating a quality management system, but this leadership requires a dedicated staff that many companies can’t afford. Outsourced quality support services are an ideal solution to this challenge.
Regulatory Compliance Associates can meet a variety of quality assurance services throughout your company’s product life cycle. Our quality consulting Experts provide trusted expertise while saving the money of hiring in-house staff. RCA can assist in situations such as:
- Short-term augmentation due to transitions in staff:
- Quality Assurance Consultant
- Quality Control Consultant
- Quality Engineering Consultant
- Quality Management Consultant
- Quality Systems Consultant
- Software QA Consultant
- Software Quality Assurance Consultant
- Special projects
- Strategic management and leadership of QA duties
- New companies in need of QA insights
- Root cause investigation
- Corrective and preventive action support
- Complaint handling
- Recall management
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 quality assurance services knowledge to your quality engineering team.
QA Services
- Quality Assurance Consultants – Interim Management, staff augmentation, or outsourcing quality and regulatory management has become increasingly common in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies. Business consultant needs may vary greatly depending on the lifecycle of the organization, and RCA’s quality consultants are up to the task.
- 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 management consulting 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.
QA Process
Early in a company’s lifecycle, strategic leadership is needed for product filings, regulatory pathways, manufacturing setup, and quality management systems creation. As the company matures, QA planning often transitions to a continuous improvement stage when leveraging quality assurance services makes sense.
- 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 with changing quality control in engineering teams. The pharmaceutical quality experts of Regulatory Compliance Associates bring a wealth of quality assurance management needed to help you cut cost via unique QA methodologies.
QA Planning
- 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
- 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. RCA’s quality assurance services Experts can ensure that you have the appropriate level of documentation.
- Risk Management ICH Q9 – RCA’s business management consultant team can provide you with the tools needed to implement or remediate your quality systems. Every RCA® quality technical consultant understands current industry standards and how to train your personnel.
QA Teams
- Corrective and Preventive Action (CAPA) and Complaint Systems – We manage the 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
Medical Device Single Audit Program (MDSAP)
Regulatory Compliance Associates will help you navigate required activities as you prepare for an MDSAP audit. We offer MDSAP-based medical device quality consultant services to support you in the following areas:
- Gap assessments to evaluate MDSAP requirement compliance
- System improvements to assist with the transition to MDSAP
- Preparation assistance and mock audits for the rigorous MDSAP audit process
ISO 13485
When you face restrictive deadlines to meet ISO 13485 requirements, Regulatory Compliance Associates quality assurance specialists are here. Our quality management system consultant team offers the following quality assurance services, including:
- Quality system transition and implementation
- Quality system gap assessments
- Readiness audits
- Risk management (ISO 14971)
- Data Integrity
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Pharmaceutical
- 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.