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For quality leaders in life sciences industries, the top three challenges are:

  1. Maintaining compliance,
  2. Improving manufacturing/production performance, and
  3. Bringing new products to market.

In addition to these, a Deloitte report in 2020 adds drug pricing and software-related regulations to the list of challenges faced by quality leaders in the life sciences industry.

Moreover, the life sciences businesses are limited by the lack of enough budgetary and human resources to be able to handle the increasing regulatory demands that require an end-to-end view of operations and quality-related data. Moreover, quality leaders are realizing that supplier quality management and regulatory training are two other areas that need careful attention – in order to drive continuous improvement of quality metrics.

Pricing – In Sharp Focus

The cost of healthcare is one of the hottest debated topics today and life sciences companies are increasingly needed to report and have oversight of pricing and payment arrangements as part of their regulatory compliance programs. The Health Resource and Services Administration (HRSA) announced a new secure pricing component of the Office of Pharmacy Affairs Information System (OPAIS), providing covered-entity and manufacturer-authorized users access to 340B Ceiling Price and Manufacturer Civil Monetary Penalties Final Rule 8.

As per this requirement, drug manufacturers need to conform to Provisional 340B Ceiling Prices for new products and refund wherever they have overcharged covered entities within four months.

The current accounting and finance practices of drug manufacturers are distributed across different functions and there is seldom a coordinated strategy that can help with appropriate pricing and meeting the reporting requirements. Manufacturers not only need to mitigate the risks but also prepare for HRSA audits. State and federal bodies are also demanding greater transparency through periodic updates on arriving at the drug pricing and reporting price increase thresholds.

This has increased the stress on integrated, enterprise-wide gross-to-net pricing models to enable a strategic view of drug pricing compliance. Noncompliance to the new price transparency requirements can lead to public disclosure and the possible exposure of trade secrets, leaving businesses vulnerable.

A cohesive strategy that stresses on value-based contracts (VBCs) by relating payment to its value is becoming the order of the day and requires businesses to develop a model for forecasting and scenario analysis for possible VBCs of its products portfolio. It should be able to predict the financial impact and share it with a cross-functional team to understand the implications for the business. It will have an impact on the contract arrangements and needs current processes, documentation, and systems to be updated. It will require change management for any new contracting approach that is implemented.

An end-to-end quality management system such as the one from ComplianceQuest provides a comprehensive and enterprise-wide view that enables life sciences companies with the ability to create strategies around pricing and enables VBC.

A rapidly growing biotechnology company that develops a novel category of therapies for GI-related chronic diseases implemented ComplianceQuest’s EQMS to automate and digitally transform key aspects of its quality workflow, with special focus on document management, change management, and training. The key reasons for adopting ComplianceQuest’s solution included its:

  1. Comprehensive yet flexible approach to designing a workflow that works for your enterprise
  2. Platform capabilities that enable a roadmap for product innovation with a deep focus on quality
  3. A best practices-based integration strategy and validation

Compliance Needs for ‘Software as a Medical Device’ Manufacturers

Quality leaders in Medical Device manufacturing companies also find that they have a variety of regulations to comply with – right from the quality of the product to the embedded software, there are a number of standards that are ever-evolving. Software companies that have forayed in this highly-regulated world to develop Software as a Medical Device (SaMD) are unused to stringent government oversight, working with a complex environment such as hospitals or understanding controls and risks. Used to a faster product development lifecycle, their inexperience reflects in the lack of controls or oversight that traditional manufacturers are aware of and better prepared for.

For the traditional as well as new medical device businesses, a QMS approach that is risk-based and encompasses supply chains right from supplier qualification to supplier contracts and integrating with suppliers’ quality protocols is essential. They need a comprehensive system that seamlessly automates workflows around device risk analysis and classification, post market analysis, product design feedback processes, and traceability across the product development lifecycle in compliance with various regulatory requirements such as EU MDR/IVDR, MDSAP, FDA and so on.

Cybersecurity is another area that needs keen focus especially as data integrity and safety are also becoming important compliance issues with regulations such as GDPR and HIPAA constantly revising requirements based on newly emerging threats and breaches.

A medical device company specializing in neurostimulation technology had an assortment of separate unintegrated applications, which led to disconnected silos of information and frustrating inefficiencies. This made every aspect of the operations, be it document management, complaints handling, inventory management, tracking growth and, naturally, compliance, a real challenge.

The company chose ComplianceQuest’s quality management system, native to the Salesforce platform, to streamline its quality, compliance, content and collaboration management initiatives and strategies and integrate seamlessly with its Cloud ERP, also built on Salesforce.com. By standardizing their quality management system, they were able to better ensure patient safety and compliance with FDA regulations as well as accelerate its growth. (Read case study here)

Risk-Based Approach to QMS for Life Sciences Industry

The world of compliance is not simple by any means. Quality leaders in life science companies often look for technology solutions and try to fit them into their business processes. This can be limiting and ineffective. For an effective quality management system that flows with its operations and integrates functions seamlessly and flexibly, it is essential to establish a continuous risk assessment and monitoring program.

An optic technology company that leverages the power of light had a siloed approach to document and quality management that couldn’t have helped the company sustain its 15% CAGR for long. They chose ComplianceQuest’s EQMS to replace its dozens of manual systems and unify the entire operation.

This helped them reduce their return material authorization (RMA) rate from 3% to 0.3%, reduce scrap, which resulted in a $400,000 cost savings, and defect rates dropped from 8% to 1% or less.

The non-conformance that resulted from manual systems had been negatively impacting its bottom line. With automation, the gross margins rose from 50% to 68%. (Read case study here).

A solution such as the ComplianceQuest’s EQMS aligns with all the major regulatory standards and its scalable and flexible architecture helps businesses adopt a risk-based approach to ensure:

  • Identifying and mitigating risks
  • Continuous improvements
  • Ease of compliance, thanks to a collaborative and data-driven workflow

It empowers quality leaders with transparency and traceability, with integrated root cause analysis and CAPA management where required. Change management, inspection and audit management also automate the workflows and improve compliance. Document management is also made intuitive and facilitates reporting in a timely manner.

In the complex world of stringent regulatory requirements that can vary from region to region and requires the same organization to manage the variations in their different units in a centralized manner, ComplianceQuest’s EQMS can provide the flexibility and scalability they so need to minimize the risk of non-compliance and the resulting product recalls, penalties and brand erosion.

To know more about how your life sciences organization can benefit from our EQMS solution, visit: http://www.compliancequest.com/industry/healthcare-life-sciences/

We wanted a cloud-based system, that would be quick to implement, that could be expanded globally and in other languages, all for a reasonable price. The user interface it is exactly what I was hoping for. I constantly hear the staff saying, I love CQ, it’s so straightforward to use. The implementation team has met all my expectations. The CQ product `out of the box’ meets the majority of my requirements. No customization required! The implementation team offer many industry best practices as solutions to questions and are also highly competent in listening to your requirements and doing whatever is necessary to fulfill them.

~Donna Matuizek, Sr Director, Quality, Just Biotherapeutics

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