Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company
To fulfill the needs of trending technologies and Life Science needs, a global supplier management program helps to integrate an appropriate level of assurance that suppliers and vendors are able to consistently supply quality of materials and services that are in compliance with regulatory requirements.
Have you considered whether your integrated supplier management program:
- Is validated to effectively help your company to asses, manage and monitor supplier qualifications, and risk and compliance across your global supply chain process?
- Is consistently producing the expected results for the intended use that your company is continuously seeking?
In the innovative, fast-paced, and challenging Life Science industry, there are number of ways to enhance and influence the relationship with suppliers worldwide. A robust supplier management program provides a framework to help companies assess and manage both, small and large-scale suppliers, complete incoming inspections, correct and resolve defects, conduct supplier audits and evaluate supplier performance through scorecards. Along with cross-functional global needs, it is important to develop, implement and maintain a Supplier Quality Management (SQM) ecosystem that aligns business practices, requirements, regulatory compliance and can integrate across other quality management processes.
Nothing is wrong with these trending requests, as it is important that a supplier management program meets business and data integrity needs, comply with regulatory requirements, and yield accurate results. Typically, defining business and user requirements for a supplier management program seems straightforward; but in reality, implementing them while meeting regulations can be tricky and is given little significance.
In a previous blog post, Joshua Centner, Industry Solutions Group Manager for Pilgrim Quality Solutions, an IQVIA company, explained and clarified Why Supplier Management Belongs in your Enterprise QMS.
A supplier management program, as part of a Quality Management System (QMS), is subject to validation for its intended use prior to initial deployment, and must remain validated throughout the life of the computer system as required by common regulations for medical devices like FDA 21 CFR Part 820.70, ISO 13485:2016, ICH Q7, Q9 & Q10 and EU Annex 11. Understanding the regulatory requirements and the risks associated with failing to meet computer system validation regulations can ensure Life Science companies are producing safe and reliable products and services.
The general validation definition of a computer system refers to the generated documentation confirming that the software consistently produces the results for its intended use. However, it is much more than that. Validation ensures accuracy, reliability, consistent independent performance, data integrity, etc.
Unfortunately, validation practices and policies for the development, implementation, and maintenance of a supplier management program are hardly considered by the companies acquiring the software. As a result, a lack of controls or the absence of a validation strategy in the design and implementation of a quality computer system to can cost millions in shortfalls to Life Science companies.
Validation of your supplier management program ensures that correct functionality has been defined and verified to yield results that meet the requirements in a stable and reproducible way. Failure to do so is the most common pitfall in complying with regulatory requirements.
Supplier Management Validation Challenges
The process does not occur organically, and as such, there are challenges in validating a supplier management program:
- Regulatory knowledge – is needed to identify the inventory of the software used and the intended use, and to define whether validation is necessary
- Time and manpower – must be scaled accordingly as a lack of resources and misleading planning may induce organizations to cut corners, later resulting in system discrepancies
- Defined user requirements – are essential to prevent incorrect or missing user requirements from potentially resulting in inaccurate intended use
- Risk management – requires that validation be proportional to the risk and complexity of the software’s intended use
- Validation costs – can easily exceed overall cost of use, if automated validation capabilities or cost-effective resources cannot be leveraged as part of the validation process
Partner with Validation Experts
It is a fact, that life-science companies are legally bound to validate any supplier management software that is used as part of the QMS.
Don’t allow inaccurate evaluation, selection, and maintenance of your suppliers to impact your organization’s compliance and product quality.
Pilgrim Quality Solutions computer system validation specialists are ready to work with customers to assist in validation activities for the implementation of a robust and efficient supplier management system, while significantly decreasing the time and cost required, and still enabling manufacturers to be in control of their suppliers and in compliance with the regulations.
Quality In, Quality Out
Exploring Pharmaceutical and Medical Device Supplier Quality Management (Part 1 of 4).