An investment in nonconformance management software can make or break your company.
Choose the right software, and you can streamline and master your conformance processes. Choose a bloated, ineffective software, and you can quickly open your organization up to the risks of skyrocketing nonconformance costs, including internal and external failure costs, FDA warning letters, and regulatory fines.
The "cost of conformance" is an operating cost for organizations in FDA-regulated industries such as pharma, medical devices, and life sciences. Project Manager Edward Chung defines conformance costs as the activities required to ensure a product conforms to quality requirements and avoids failure, including building quality into processes, appraisal costs, and prevention costs.
The right software can enable your organization to prevent expensive nonconformances, streamline conformance management, and improve quality processes. Our product includes nonconformance management, so we have an obvious bias, but here are a few options in addition to Qualio we would recommend assessing.
Nonconformance Management Software: What It Does And Why You Need It
Nonconformance management software provides features and support for the identification and management of product conformance within the context of a quality management system (QMS). Features should include all steps necessary to identify and resolve internal and external nonconformance issues, including support for identification, remedial action, root cause identification, CAPA, and resolution, including the generation of corrective actions linked to nonconformances per regulatory requirements.
A nonconformance management software may be a stand-alone solution or a component of a comprehensive QMS software. Regardless of whether it is a point solution or suite, nonconformance software should address risks and allow stakeholders to browse conformance notifications, reminders, and escalated issues related to quality issues. The right software can deliver multiple quality benefits to the enterprise, which include:
- Lower quality costs
- Improved consistency
- Optimized quality assurance
- Stronger collaboration
- Better risk response
- Stronger compliance
RELATED READING: 13 Bottom Line-Boosting Benefits of a Quality Management System
Intelex is an environmental health and safety application (EHS) designed for compliance with OSHAS 18001 and CAPA in numerous fields, including organizations with complex requirements such as water quality management, waste management, and permit management. The solution includes support for documents, training, audits, inspections, and risk assessment, including a comprehensive CAPA suite to address nonconformance issues.
- Highly sophisticated and extensible platform for multiple industries
- Provides multi-lingual support for global organizations
- Adoption may require custom development using Intelex developers
- Easy-to-learn reporting module and incident workflow features
- Frequently requires customization or configuration to meet industry requirements or use cases
- Extensible platform necessitates clear solution design
- Some users on Software Advice report minor user interface (UI) frustrations
One implementation partner on Software Advice recommends Intelex for the needs of “complex corporations” in multiple industries due to the platform’s extreme potential for customization and configuration to meet many different use cases and potential to act as a robust solution for environmental health and safety. Free trials of Intelex are available by request.
Chances are, you've heard of IQVIA QMS--the parent brand behind Pilgrim Quality Solutions and SmartSolve® Nonconformance Management software. This SaaS application for nonconformance management is designed to create automation in risk-focused conformance management by managing quality, suppliers, and regulatory risk. Pilgrim includes workflows, document management, process management, analytics, and validation features.
- Offers flexible workflow configuration to meet the needs of small or large organizations
- Comprehensive, easy-to-use documentation for self-service
- Intuitive user interface and dashboard features
- Users report satisfaction with customer support experience
- Workflows can quickly become "cumbersome" according to user reviews
- Users report limited implementation, data validation, and training support
- Limited functionality without the purchase of full QMS product
- Users say data quality and change control issues resulting from a non-normalized database
Pilgrim Quality Solutions may be an appealing option for organizations with the internal resources necessary for data validation who want nonconformance management software as part of a comprehensive QMS suite. Product demos are available.
Qualityze is an eQMS cloud solution which, according to the vendor, is adopted by manufacturing customers of all sizes in many different highly regulated industries including automotive, defense, and logistics. Qualityze offers a comprehensive eQMS suite of products, including management features for nonconformance, CAPA, change, audits, training, and documentation. Nonconformance features are defined as "the ability to identify and document an issue" and "analytics." Pricing is transparently posted online beginning at $20 per user per month.
- Online user reviews report fast time-to-implementation and intuitive software
- Built on Salesforce
- Efficient, streamlined workflows and simplicity
- Closed-loop management processes
- User reviews report the need for additional feature expansion
- Limited online user reviews
Qualityze may be the right solution for your organization if you are searching for simple nonconformance software as part of a cloud-based eQMS for use in a highly regulated manufacturing field and you're willing to work closely with the vendor to determine goodness-of-fit based on client success stories at organizations which resemble your own. Qualityze offers a demo and a 1-week free trial to prospective clients.
Verse is an integrated solution for EHS and good manufacturing practices (GMP) which is categorized as total quality management (TQM) software for organizations in highly regulated industries. There are several versions of Verse, including Verse for Life Sciences organizations. Verse for Life Sciences is designed to create an "audit-ready" state with features for handling complaints, corrective action, risk management, and compliance. Software reviews online which address solution pros and cons are focused primarily on Verse Standard, as opposed to implementations of Verse for Life Sciences.
- Users report the solution offers excellent value for the cost
- A wide array of modules and rich features
- Provides automation for enterprise quality systems and processes
- Users report implementations ran significantly longer than expected due to poor support
- One user reported a failed implementation due to poor vendor support
- A third user reported poor communication with the support team
Verse may be worth exploration if your organization is seeking a solution specifically designed for life sciences. The vendor offers a free, customized demo.
Qualio is an all-in-one quality management software (QMS) designed as a single, efficient, and automated cloud platform for organizations in pharma, life sciences, and medical device industries.
Qualio offers comprehensive QMS features which include training, document management, closed-loop quality, product development, and quality event analysis, including nonconformances. Customers are empowered to proactively address quality events like deviations, nonconformances and customer complaints with features for investigation, root cause analysis, outcome validation, and closure. Qualio's nonconformance features also allow organizations to assign CAPA-related tasks, track progress, monitor quality trends, and link conformance-related activities.
- User reviews report simplicity and ease-of-configuration
- Described by adopters as "the perfect software for startups and young organizations."
- Simplifies compliance with audit-ready reporting
- Users report satisfaction with making feature and improvement requests to the support team
- One adopting organization reported the business benefits of “swift” SOC certification, increased customer trust, and bottom-line growth
- Users report an occasional need to conduct sophisticated data reporting in external business intelligence tools
Qualio may be the right choice for your organization if you are a small to midsize life sciences company looking to establish a quality-driven culture and scale nonconformance processes as you grow. Click here to schedule a demo.
Creating A Culture of Quality
Failure to discover quality issues and product deviations can result in external nonconformance issues which come with regulatory risk, a loss of customer trust, and damage to your organization’s reputation.
Conformance costs are a part of doing business in any quality-driven, highly regulated industry. However, the best options for nonconformance management software can enable you to build conformance management, identification, and resolution into your business processes and manage costs and quality closely and proactively.
How does your organization stack up against industry benchmarks for quality, including the risk of adverse findings? Take a short, self-guided survey to learn more. Click here to get your quality score today!