Future-Proof Pharmaceutical Compliance with an Effective QMS

One of the five key questions leaders must ask themselves these days is ‘How can we prepare for an uncertain future?’, according to an HBR article. It lays stress on developing the capability to deal with uncertainty rather than trying to forecast trends.

While this holds true across sectors, leaders in the pharmaceutical sector truly resonate with this, especially after the pandemic.

In order to grow and scale pharma and biotech companies, leaders in this sector must have a mindset of constantly analyzing their overall strategy, operations, and people processes from a systemic perspective. What does that mean on the ground? This essentially refers to the ability to review strategy documents, workflows, and processes – with the goal of identifying gaps and planning Continuous Improvement (CI) initiatives. This approach is especially critical in processes related to quality, safety, and day-to-day operations.

As the founder of Intel, Andy Grove, wrote in his book, ‘Only the Paranoid Survive’ – it is critical for companies to exploit opportunities during difficult times. This concept has never been more important. The pandemic taught business leaders why being reactive is not enough, especially when it comes to dealing with uncertainty and business disruptions.

What does all of this mean from a quality management standpoint?

The need of the hour in the pharma sector is to build a holistic, connected Quality Management System. To execute quality processes, there is a crying need to implement modern EQMS Software that enables data-driven decision-making, easy collaboration, and improved productivity. Quality leaders are looking for a “system of engagement” that rallies around multidisciplinary teams to contribute to overall quality performance. There also has to be a better, more efficient way to keep up with regulations.

Product Quality, Patient Safety and Improved Compliance

The pharmaceutical industry is highly regulated for obvious reasons; product quality has a direct impact on patient safety and quality of healthcare. Therefore, regulatory and compliance processes are fairly detailed and sometimes complex. Using a next-generation EQMS to automate quality control, risk management, compliance, complaint handling, clinical quality management and overall quality performance is, therefore, obvious.

Additionally, in the pharmaceutical sector, the costs associated with rework, product recalls, regulatory fines and safety mishaps are extremely high. There’s also the long product development cycle starting right at the research and clinical trial stages.

Audits and inspections, Document Management, management of raw materials across the supply chain, ongoing training – each of these processes need to be automated.

Moreover, the regulations and compliance requirements are constantly being fine-tuned due to increasing risks and requiring a robust Change Management process.

Meeting the existing laws and guidelines can be time-consuming, making it difficult for pharma companies to anticipate and prepare for future needs. The future can be daunting when the current requirements are increasing and demanding all time and attention of key stakeholders.

Understanding this dilemma, regulatory standards and laws encourage businesses to become future-proof by shifting the focus from compliance to Risk Mitigation as a strategy. By making informed management decisions based on risks, businesses can:

• Implement best practices
• Simplify systems
• Become proactive in quality management

Future-Proof Pharma Compliance with a Cloud-Based EQMS

According to one study, the cost of non-compliance is 2.71 times that of compliance. Often, the costs are incurred after an event in the form of penalties, litigation, recalls, and so on, instead of being invested in risk management to improve compliance. Naturally, this impacts the bottom line, the reputation of the business, and the growth potential.

Future-proofing pharma companies involves Risk Management to empower quality leaders and management with enterprise-wide data that can provide them with insights and visibility into the processes. Some of the best practices to strengthen the company to be able to overcome the uncertainties and leverage future opportunities include the following:

#1 – Benchmark Your QMS with Industry-Wide Best Practices (like ICH Q10 guidelines)

Flexibility, scalability, data analytics, and a culture of quality are essential to make a business future ready. Adapting to changes quickly and with agility is a survival need. The ICH Q10 guidelines can provide the way forward, and rests on the four pillars of:

• Process and Product Monitoring
• CAPA
• Change Management
• Management Review

Some of the key features of a Quality Management System such as ComplianceQuest that can help with this include:

• Management review, where real-time data provides the senior management with a tower of quality data to review and make informed decisions
• Risk management with a centralized risk registry to capture trends and assessment matrix to prioritize risk management based on frequency and severity
• Document Management for easy creation, storage, retrieval, version control, and removal of relevant documents
• Audit Management to schedule, manage, and record audits and findings
• CAPA is backed by root cause analysis to identify the root cause and prevent future recurrence

The CQ EQMS integrates with enterprise systems such as ERP, CRM, and PLM, to provide a 360-degree view of all processes with data at the core.

#2 – Implement a QMS that Serves Not Only the Quality Team but the Entire Organization

Our MyCQ feature enables Total Employee Involvement. The involvement and commitment of employees in quality management are critical factors for the success of the system.

Infrequent/casual users make up a big portion of the people who regularly use a QMS. These users are, often, not familiar with quality processes or the QMS software, yet they still are regularly required to complete certain actions within the QMS such as trainings, approvals, sign offs, generate reports, access documents and more

To perform the actions required from them they need a platform that is:

• Intuitive and easy to use
• Easily accessible from any device and at any time
• That is personalized and shows them all the tasks assigned to them in one place

With ComplianceQuest EQMS, each of this becomes easy and efficient.

#3 – Implement a Configurable QMS that is Flexible

Quality practices should seamlessly align with business processes and not vice versa. This is essential to accelerate the adoption of quality processes without intimidating users and enabling them to embrace best practices without losing sight of their responsibilities.

CQ EQMS, thanks to being built on the Salesforce Platform, is extremely flexible and customizable. It offers a low-code solution that is easy to configure as per the workflow needed by the company.

#4 – Management of Change (MoC) is a Key Requirement and your EQMS Must Come with an Integrated Change Management Solution

Change is the only constant, and ensuring a smooth transition with minimum disruption to business processes is crucial. Enabling a planned and systemic change is possible with the PDCA cycle of Plan, Do, Check and Act – which helps anticipate changes and risks and prepare accordingly. This can also help with managing regulatory changes or other sector and business-related changes with risk management.

With ComplianceQuest, change can be initiated from anywhere in your organization. CQ Change Management Software allows you and your supply chain partners to establish and follow best practice workflows to address the entire change management lifecycle.

The software supports each aspect of your own change management process from initiation and review/approval through to execution tracking, verification and closure.

#5: Integrated EDMS (Enterprise Document Management System) is Crucial

Creating and managing documents is a key regulatory requirement in the pharma sector. Just as important is to have access to the right documents at the right time.

ComplianceQuest provides a centralized system for the management of the above processes with sufficient security and permission controls. Being cloud-based, it also helps business users with accessing data/information from anywhere, anytime to make meaningful decisions in a timely manner.

This helps with identifying trends and putting in place controls for risks while leveraging opportunities. It improves compliance, enhances product and process quality, improves efficiency and productivity, allowing businesses to break barriers to innovation and accelerate growth. It helps pharma businesses become future-proof by anticipating and preparing in time for any disruption and protecting their investments.

At ComplianceQuest, we’ve helped pharmaceutical companies in 1000+ locations around the world by automating and streamlining their quality management system. To know more, request a demo here: https://www.compliancequest.com/online-demo/