Life Sciences manufacturers are faced with enormous challenges in managing quality and compliance. The expectation of quality teams to add value across the entire business has never been greater, supporting key enterprise-wide initiatives, accelerating product innovation and time-to-market, and delivering a mission-critical cross-functional service.

The right quality management system (QMS) can help deliver value and increase an organization’s overall agility, scalability and productivity. However, with many manufacturers focused on managing costs, you need a strong business case to gain buy-in for any QMS investment.

Consider QMS Investment Options vs QMS Requirements

If you’re on the team responsible for product quality and regulatory compliance, you might have already decided that your organization needs to invest in its QMS to overcome specific challenges. But how do you determine the right level of investment? The necessary investment will depend on whether you want to expand an existing QMS solution or implement a new one. Each option requires its own evaluation and mapping-to-requirements and will involve additional tasks or components in your business case calculations.

There are some QMS requirements that can quickly determine initial QMS investment options:

Requirements for Expanding an Existing QMS

  • New processes
  • New capabilities
  • New business group or department
  • New sites
  • More users

Requirements for Implementing a New QMS

  • Transition from paper or manual systems
  • Consolidation of multiple disparate systems
  • Replacement of outdated system
  • Migration to digital technology

QMS Deployment Options

Traditionally, QMS solutions are focused on managing, tracking and reporting a company’s quality management processes, including incident management, corrective and preventive action (CAPA), audit management, complaint handling and change control. Advances in technology—and evolving regulatory requirements—drove the adoption of QMS software.

Customer needs prompted QMS vendors to add additional capabilities, such as document management and training management. A decade ago, QMS software solutions were hosted only on-premises. Since then, advances in technology have led to the development of cloud-based QMS solutions. Innovation like this has opened more QMS options than previously available. There are now typically three main options for QMS deployment:

Modern on-premises QMS

  • Interest in modern features/functions and enhanced user experience
  • Need to implement or maintain numerous custom configurations
  • Need to maintain onsite storage of quality data
  • Limited or unreliable internet access
  • No digital or cloud initiatives imposed on the quality group

Hybrid QMS environment

  • Preference to extend existing on-prem QMS investment
  • Outsourced manufacturing, or a complex supply chain
  • Recent acquisition of a business or product line with independent processes
  • Preference to maintain an on-premises QMS at one or more sites, while enjoying faster deployment and affordable scalability at other sites
  • Need to gain insight into the supply chain without giving suppliers direct access your QMS

Fully Digital Cloud

  • Internal ‘cloud’ strategy
  • One or more digital transformation champions
  • Adopting innovation such as smart sensors and equipment, AI capabilities and more
  • Greater access to digital documents needed to support a mobile workforce and culture of quality
  • Workflow optimization by using pre-validated process configurations
  • Advanced reporting and analytics to monitor quality events and metrics

Get Started on Building Your Business Case for QMS Investment Today

Your QMS should be a vital part of your overall digital strategy. As a result, many companies now evaluate their current and future QMS needs against a QMS digital maturity model.

Download the white paper to learn how to apply this QMS digital maturity model and for more insights into making your business case QMS investment, including:

  • How to identify key stakeholders
  • Tips for ensuring a compelling and competitive case
  • 5 actionable steps for building your business case