The only thing constant these days is change. Pharmaceutical, Biotech, and Medical Device companies are constantly dealing with change.  Local, state, federal, and country specific guidance’s and regulations change all the time.  Keeping up on these changes is a fulltime job and more.  Figuring out where and how they may apply to your organization is another feat within itself.

RCM’s Regulatory Compliance (RC) Practice continues to review proposed changes and assess potential impact to the industry.

RCM can answer your questions! Couple this with our Audit Services and you will see the unique qualifications that RCM can bring to your organization.

Worried about data integrity? RCM can help to ensure that your data is secure by training your employees on ways to protect their data.

  • RCM offers our advisory services as a subscription service or by project.  Each member of RCM’s Advisory Team has more than 20 years of experience
  • Talk to a Senior Advisor. RCM can help you avoid a 483 and preparing for an Audit.

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FDA 

What’s all the fuss about CSA and why is it becoming important to computer software validation, especially  for MedTech companies? CSA is a methodology for process improvement by which you change the way you perform validation through planning, assessing, automating and implementing.

It requires replacing old processes with new processes, developing success criteria and metrics, such as Key Performance Indicators (KPI) and/or Software-Level Agreement (SLA) with suppliers/vendor/partners, and addressing the barriers to transformation your organization’s change management (OCM).

New technical competencies need to be developed through learning management programs to train employees on the new FDA guidance. Software Suppliers and Vendors assume responsibility for compliance with FDA regulations during development.

This saves time, resources, and more and assures that the software works the way it was intended to. For more information see RCM’s whitepapers and blogs.

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Computer Software Assurance

FDA guidance presents new industry challenges for the Life Sciences industry…

In a report published by FDA in 2011 on Medical, FDA identified seven major opportunities to improve quality in the industry to enhance operating systems, enhance management infrastructure, and enhance mindset and behavior. The tenets of CSA (i.e., critical thinking, risk management, patient and product safety, and quality) are important and need to be finetuned to achievable improved quality, improved efficiencies, and shorter time-to-market.

RCM has skilled consultants to support and train your teams on CSA tenants. We do this by performing an assessment of your organizations, holding webinars, and providing consultations and collaboration.

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We build a deeper knowledge of risk management and refining your quality assurance and quality control processes, new techniques and technologies are introduced and implemented. See our white papers and case studies for recent examples of how we collaborated with our clients to achieve CSA this using new techniques and streamline development , while building in the testing and validation checks for continuous software development.

We can help you get started by assessing your organization(s) and identifying the Software Development Life Cycle (SDLC) phases that will need to be updated to align with the CSA guidance.

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Some of the tools and methods in support of continuous software development require you to use automated testing tools for software development. We can assist you in this process by identifying what can be automated and the impact it has on shortening the life cycle of validation.

As we continue to build on the challenges ahead, our knowledge, capabilities, and current experience speaks for itself. Your challenges are our challenges and through teamwork and collaboration, we can see clearly, the path forward to success.

From a cost perspective, we have consultants throughout the US, Puerto Rico, and Serbia. Why is this important? Because we can assemble a team quickly, offer skilled consultants, both on-site and remote, and use a balanced approach for cost savings. Contact us to learn more.

Bill Gargano

Group SVP