01.3.2019 Robert Fenton

Understanding the Growing Need for Product Compliance Software in the Life Sciences Industry

The life sciences industry is under an incredible amount of pressure from regulatory authorities, patients, and market conditions. Regulatory requirements are continually expanding. Legislators and patients are putting downward pressure on product pricing. The rate of marketplace innovation requires organizations to streamline processes for research, development, and approval.

To remain competitive, life sciences organizations can no longer afford a reactive approach to compliance. Compliance teams and solutions need to shift to a proactive stance on compliance and driving growth. According to Deloitte, aligning compliance with business strategy can allow life sciences organizations to better respond to external pressures. This can be achieved, in part, with product compliance software that encourages flexibility and an "enterprise-wide view of risk and compliance."

Your organization can reduce regulatory risk with modern software for life sciences product compliance, but this isn’t the only benefit of a Quality Management System. The right solutions can drive transformation throughout the organization with opportunities for cost reduction, new capabilities, and smarter collaboration. In this post, you’ll learn why life sciences companies need product compliance software more than ever, and the potential benefits of adoption.

The Benefits of Product Compliance Software for Life Sciences Companies

A vital goal of the compliance function in life sciences is to gain the regulatory product approval necessary for long-term company profitability, regardless of whether you are manufacturing medical devices or biologics.

However, PharmaExec reports that in recent years the average time-to-approval has increased significantly due to factors such as working with third-party reviewers and an increased volume and variety of products for review. Simultaneously, there has been a surge in FDA recalls since 2012 due to highly publicized concerns such as drug contamination.

Learn more in The Keys to Successful Life Sciences Product Development.

Organizations that adopt product compliance software can gain a significant competitive advantage when it comes to product approvals. Compliance with regulations for drugs or devices is simplified with a centralized quality management system software for documents, audit trails, standard operating procedures (SOPs), and CAPA. By adopting software that puts compliance at the core of life sciences operating processes, your company can adhere to regulatory requirements from the beginning of the research and development phase.

What is Product Compliance Software?

Life sciences product compliance software is a specialized category of software designed for total quality management with regulatory requirements throughout the product lifecycle. While it is a relatively narrow category of technology, a search on G2 crowd reveals industry vendors can use several different terms to describe their technology product, including:

  • Quality Management Software (QMS or eQMS)
  • Product Realization Software
  • Enterprise Electronic Labeling

The purpose of a product compliance software in the life sciences industry should be to modernize compliance with features that create traceable audit trails, automate quality management, streamline team communication, and comply with FDA/ISO best practices. It should also act as the arm of the quality and compliance function and help organizations achieve Deloitte's six goals of a modern compliance program:

  1. Transformative change
  2. Flexibility
  3. Increased capacity
  4. New competencies
  5. Cost reduction
  6. Comprehensive view of risk and compliance

The "best" type of product software to modernize compliance can vary according to a life science company's size and stage in the product realization process. However, industry pressures have created a strong trend away from outdated "point solutions" for compliance which offers a limited view of enterprise risk and opportunity. Today's most effective solutions for life sciences compliance at organizations of any size are defined by scalability, unified systems, and audit-ready documentation.

Feature #1: Flexible Scalability

In the past, life sciences companies relied on standalone solutions to solve software needs within the product lifecycle. Products often served a single operational use case, such as product management or registration and tracking.

Point solutions were a barrier to flexibility and agility, because compliance, quality, and leadership lacked a unified view of the product and compliance. Due to the high volume of stakeholders involved in review and sign-off, making a single change to one component could complicate the rest of the system.

To achieve flexible scalability in response to modern pressures, life sciences organizations need product software which offers a flexible, unified view of quality management processes to detect risk and opportunity in real-time. Adopting cloud-based solutions can unite global stakeholders and allow cost-controlled investment in a compliance infrastructure which scales quickly.

Flexible compliance software can also offer particular benefit to life sciences organizations in the startup or scale-up stage of the company lifecycle by scaling from document management and training to CAPA as the organization approaches product approval.

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Feature #2: Unified Systems

Interoperable, unified systems is a necessity in life sciences product compliance software. At companies of any size, global stakeholders and processes must align on a daily basis to meet regulatory requirements for data storage and review. Solutions which don’t interact are a barrier to rapid change and can complicate the process of quality management and compliance.

Unified systems can allow life sciences organizations to track every action and change with integrated, closed-loop processes for quality that keep all stakeholders informed of risk. Centralized systems can offer the benefit of intelligently linked records and robust reporting for product approval and audit trails.

In a competitive marketplace, integrated systems carry the benefit of productivity and automation. As life sciences companies race against the clock to meet regulatory requirements, unified systems can offer a data-driven view of performance, risk, and quality in real-time. Organizations can streamline regulatory requirements with features for guided workflows, automated reminders, and linked quality processes.

Feature #3: Audit-Ready Documentation

Regulatory requirements have never been steeper for life sciences organizations. Companies are facing increased requirements and expectations from regulatory bodies and an increase in examinations and inspections. These pressures are coupled with the reality of operational complexity and global workforces.

Product management software for life sciences should help your company achieve its goals by simplifying the process of creating audit-ready documentation throughout the product lifecycle. This is accomplished, at a high level, with products to increase the visibility of data, simplify collaboration, and increase organizational knowledge of quality and compliance.

While regulatory requirements for life sciences can vary, audit-ready documentation should be maintained according to the latest pharmaceutical, medical device, and biologics guidance from regulatory bodies.

Finding the Right Product Compliance Software for Your Company

Compliance is no longer a stand-alone function at life sciences organizations due to heightened market pressures and regulatory requirements. Increasingly, compliance is converging with quality management and leadership functions as a part of the life sciences strategy. The best product compliance software for your company is likely to create a unified view of the product lifecycle, offer flexibility, and significantly simplify the process of creating audit-ready documentation.

Qualio is the first cloud QMS designed in accordance with the latest FDA, ISO, medical device, and therapeutics best practices for companies in life sciences. It offers end-to-end traceability, streamlined communications, and automated workflows for life sciences startups, scale-ups, and small and mid-sized organizations. To learn more, click here for a Qualio product demo. 

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Published by Robert Fenton January 3, 2019
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