Regulatory Compliance Associates® Inc.’s 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 assurance 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 assurance engineering team.

 

 

Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through a company’s lifecycle.

 

QA Services

  • 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 quality assurance 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. 

 

QA Process

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, quality assurance planning often transitions to a continuous improvement stage.

 

  • Total Quality Assurance
    • Quality Assurance Methodologies
    • Quality Assurance Procedures
    • Project Quality Assurance
    • Product Quality Assurance
    • Supplier Quality Assurance
    • Digital Quality Assurance
    • Agile Quality Assurance

 

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.

 

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
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    • 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.
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QA Teams

  • 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
    • Quality Assurance process
    • Quality Assurance Tester
    • QA Analyst
    • QA Management
  • Laboratory Support
    • SOP Development
    • Method Transfer
    • Method Validation
    • Data Quality Assurance

 

About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide 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-and globally-regulated companies.

 

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

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