Overview of Quality Management Systems Consulting
Food and Drug Administration (FDA) enforcement actions and the cost of non-compliance have become increasingly significant (i.e. increased FDA scrutiny, financial penalties, lawsuits, loss of brand integrity, etc.). Historically, the money spent on reactively addressing FDA non-compliances, and addressing quality deficiencies, has far outweighed the upfront investment of being proactive and maintaining sustainable quality management systems.
This is why companies who have realized that quality is not a “cost center”, but rather an investment, have been able to stay competitive in the marketplace and maintain high levels of product quality and brand equity.
These companies that take advantage of quality management systems consulting:
- Invest in quality
- Seek to continuously improve their business processes
- Develop sound strategies for sustainable compliance
Through quality management systems consulting, QualityHub can help you develop, improve, remediate, optimize, and/or harmonize your quality system with global regulatory requirements.
QualityHub has extensive experience with quality management systems consulting in developing strategic compliance and quality plans, which provide a clear roadmap for establishing the foundation for sustained compliance through an effective quality management system.
Our plans are carefully constructed to ensure the company secures the past through record remediation, stabilizes the current state with interim controls, and shapes the future by defining and establishing a QMS that is right for the company and its product types. Our consulting plans provide a means of documenting with objective evidence and a phase-based approach to re-developing all or part of the quality system.
Continuous improvement is an important aspect of any quality management system. As products, business, cultural and regulatory requirements evolve, the QMS must evolve. Improvements should be planned, executed and monitored by the right technical and regulatory experts.
QualityHub has subject matter experts who have managed and participated in many QMS and manufacturing process improvement projects. When appropriate, we leverage six-sigma techniques to help optimize quality, compliance, efficiency and costs.
We can provide the following services:
- Process mapping studies to identify opportunities for optimization and increased efficiency;
- Time-point and capability studies to determine appropriate resources for sustainability;
- Compliance Gap Assessments to determine issues and opportunities for improvement and alignment with best industry practices;
- Harmonization of global regulatory requirements and standards across the organization;
- Establish policies, procedures and work instructions that balance compliance and business needs;
- Align new technologies and processes with business goals;
- Assist in the development and monitoring of predefined performance metrics and analytical data that measures quality.
Following audits or regulatory inspections, record remediation may be necessary. These projects need to be done in accordance with carefully planned protocols that ensure the remediation is performed and documented correctly the first time.
Correcting deviations in legacy records can:
- Help to ensure compliance;
- Re-assess the basis for past reportability or escalation decisions;
- Improve the completeness and accuracy of data that drive quality and compliance decisions;
- Enhance the availability of data that drives quality and business analytics.
In addition to providing the strategic plans for performing and managing record remediation efforts, QualityHub can provide experienced interim professionals to help get the work done, including subject matter experts, project managers and administrative personnel.
With increased globalization, acquisitions and escalating regulatory oversight, companies are facing ever-increasing challenges to achieve operational efficiency and overall compliance as they expand to capture market share.
Medical device and pharmaceutical companies are especially vulnerable to these risks, given the nature of their products and the intense regulatory burdens.
Having a fully harmonized QMS in place enables your organization to meet the challenge to drive operational efficiency and improve overall compliance with regulations such as ISO, FDA, EUMDR and other global regulatory agencies. In addition, harmonized quality management systems can reduce unwarranted costs and risks, optimize processes, create consistency, enhance overall communication and improve product quality.
QualityHub has the experience and expertise to develop and execute your organization’s quality system harmonization initiatives. We are ready to partner with your team to supplement your project needs with the right technical and regulatory expertise.
When you partner with QualityHub, you are investing in more than a name; you are investing in a team of professionals that stand ready to execute and deliver world-class solutions to maximize your investment.
QualityHub has worked for many years with some of the largest and most recognized manufacturers of combination products. Our regulatory and quality professionals have experience in the interpretation of regulatory requirements that impact drug, biologic and medical device disciplines. This experience has enabled them to help our clients meet the bridging requirements established by the FDA in 21 CFR Part 4 to create a seamless quality management system that covers regulatory requirements for all constitute parts of their combination products.
- Train your staff in areas of the regulation that may be new to them (such as medical device or pharmaceutical GMP);
- Assess procedural gaps that need to be addressed to be compliant with Part 4;
- Harmonize medical device, drug and biologic procedures into a single system that covers the regulatory requirements for combination products;
- Prepare combination product manufacturers for regulatory inspections that may examine compliance in areas where the company and its staff have less experience.