Yanira Torrellas Cruz, President and CEO
Whether it is a start-up or an industry giant, organizations in the pharmaceutical industry are constantly under the heat of unprecedented compliance challenges that are unlikely to abate anytime soon. The need of the hour is to keep pace with this fast-paced, evolving landscape and remain compliant with regulatory requirements. “The ever-changing processes, law requirements, and Current Good Manufacturing Practice (cGMP’s) regulations are making it extremely challenging for the pharmaceutical organizations to create new products, without jeopardizing compliance level,” says Yanira Torrellas Cruz, President and CEO, Quality Consulting Group, LLC.
With over two decades of expertise in providing consultation services to the highly regulated pharmaceutical, biotechnology, and life sciences industry, Yanira emphasizes on “staying abreast with technology transformations” to remain engaged in the field. Her company, QCG addresses the needs of pharmaceutical organizations and provides a broad range of reliable services that help pharmaceutical companies to learn the fundamentals of compliance, hire qualified professionals, and use technology tools to achieve their business goals.
“Risk-based approach, lean management, continuous improvement, and innovation are the important elements that help pharmaceutical firms to thwart unprecedented compliance challenges and close regulatory scrutiny,” affirms Yanira. “We evaluate, analyze, and identify the constraints, and support our clients to gain the most appropriate level of compliance.” The company offers advanced remediation methodologies to support organizations achieve sustained compliance that ensures high level of efficiency. In addition to offering regulatory compliance services, QCG also delivers quality systems, validations, project management, remediation projects, and engineering support, among other services designed to meet client’s specific objectives.
Responding Proactively to Technological Changes
The volatile nature of pharmaceutical landscape directly impacts the creation of new drugs “New best practices and technology advances are pushing the pharmaceutical industry to re-evaluate regulated business processes,” says Yanira. QCG’s prime offering QUALINX precisely identifies the challenges around bringing out new drugs to market in a timely and efficient manner. “We bring new ideas and methods to meet the requirements of clients in an economically favorable way,” adds Yanira.
We evaluate, analyze, and identify the constraints, and support our clients to gain the most appropriate level of compliance
QUALINX strengthens the foundation of pharmaceutical organizations through a perfect combination of functions including regulatory and compliance expertise, graphic designs, technical writing skills, and communication expertise. It ensures optimized execution of critical processes, while eliminating human errors and reducing production waste, defects, downtimes, motion and processing waste. In a nutshell, it reduces disruptions that may impact the production schedule and product output numbers.
As an addition to QUALINX, QCG has introduced a new service, QUALINXS CLIPS. These are animated clips that involve a visual representation of the integration of several steps to refresh and reinforce critical and complex processes to clearly understand the needs of end users. “With this innovative solution, we are pursuing to eradicate the human error factor during execution, standardize execution among different resources, reduce process waste, and maximize effectiveness of the training process,” says Yanira.
Thinking beyond Compliance
QCG considers pharmaceutical organizations’ efficiency, compliance level, regulatory requirements, risks, and business needs as the baseline elements to provide its solutions.
“Our team of industry experts’ global regulatory knowledge coupled with industry best practices rightly integrate with our clients’ business goals and put a quality system in place,” says Yanira. “We also engage with senior management and key employees in the development phase to solve their challenges more efficiently.”
The company offers training and certification solution, Quality Academia, to enable pharmaceutical companies’ employees to meet regulatory and compliance requirements. “Quality Academia provides learning solutions that help our clients identify challenges associated with people and processes that may prevent their organizations from achieving optimal results,” says Yanira. “We partner with our customers to assess, envision, develop, and execute powerful training that increases productivity and inspires continuous focus on excellence through a wide range of learning solutions.” In addition to successful workshops, Quality Academia also provides services that include assessments and analysis, consulting, coaching, project management, and continuous improvement programs, which in turn results in improved employee skills, morale, and satisfaction.
Knowing just the regulations and following the Standard Operating Procedures (SOPs) and focusing on compliance is not just enough for the pharmaceutical companies today. The firms need to hire qualified technical professionals. To serve this purpose, QCG delivers staffing solutions, Quality Placements, which are specifically tailored to fulfill the requirements of individual projects, enabling organizations to achieve their business and professional goals. The staffing service allows businesses to work with highly qualified professionals to fill short and long-term contract positions. “We alleviate the administrative burden of recruiting, evaluating, screening, and interviewing full-time employees by providing companies with highly qualified candidates,” says Yanira. This hiring solution gives organizations the unique option to evaluate an employee’s performance on-site before making the final decision, ensuring that the new employee is a good fit. Quality Placements also provides a wide range of services within the Human Resources arena.
QCG offers its solutions as Platform as a Service (PaaS) applications that allow them to create and deploy specialized web-based software platforms, which can be operated from anywhere. It also avoids time- and resource-intensive activities which can otherwise slow down a project. “With PaaS systems, our company rapidly identifies and supports our clients around the world,” says Yanira. “And with modern cloud computing security systems and procedures, including employee training, strong access control policies, and robust encryption standards, QCG ensure that the client’s data is safe.”
"With cloud-based PaaS systems, our company is able to more rapidly identify and support our clients around the world"
QCG considers its clients’ goals, opportunities, and achievements as its own. “When clients approach us, they invite us to identify their deficiencies and opportunities,” says Yanira.
In one such instance, QCG helped a drug manufacturing firm to drastically reduce and clean the production waste and increase their productivity. “The client was spending more time on cleaning process rather than manufacturing,” says Yanira. QCG’s logistics facilities reduced the time spent on factory cleaning. It significantly increased the output of the client and gave them sufficient time to focus on important aspects of the business.
In the coming days, the company is planning to diversify its portfolio of services. QCG will introduce virtual training and implementation feature as an addition to Quality Academia. A mobile app that will enable organizations in pharmaceutical industry to support clients around the world is also in the pipeline. This app will have modules to support e-learning process, including a regulatory advice portal that will help share experiences and innovative ideas with pharmaceutical organizations. “Our reliable and best value solutions are the footprint of QCG’s brand name and we would like to retain that in the future as well,” concludes Yanira on a positive note.