Tuesday, 16 July 2019Jim Erickson, President, Blue Mountain Quality Resources
Equipment and instruments touch every aspect of a product throughout the manufacturing process. These assets are a critical component of determining the quality of the product in each stage of the manufacturing process, from raw ingredients to final form, including packaging and shipping.
In addition, assets are capital intense to purchase and maintain over time. No matter the industry, facilities constantly need to increase the utilization and uptime of their assets in order to drive the highest return on investment. However, for Life Sciences manufacturers in particular, operational compliance is critical, and the risk of non-compliance in this area can completely cancel out the potential for realizing any measurable ROI.
Tuesday, 02 July 2019Jim Erickson, President, Blue Mountain Quality Resources
Life Sciences enterprises are increasingly looking to establish a foundation for improving processes and procedures that will drive down their overall cost of production, labor, and compliance. As a result, demand is growing to adopt multi-site, GMP-compliant Asset Management software
as a pillar of that foundation.
A multi-site regulatory asset management solution enables companies to standardize maintenance and calibration procedures across all of the facilities, driving corporate efficiencies and supporting global compliance standards.
Tuesday, 25 June 2019Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Knowing your suppliers is as important as knowing the material they provide. Life Sciences regulators around the globe could not agree more! If you have a product defect, it doesn’t matter who is at “fault”, your supplier or your own organization.
Ultimately regulators are going to hold your organization (the license holder for the finished product) responsible for the quality
of the materials and services your suppliers provide you. This is evidenced in recently updated standards and regulations such as ISO 13485:2016 and EU MDR, or long-standing standards such as 21 CFR Part 820 and Part 211, or ICH Q9 and Q10. However, and more importantly, the only thing the public will see and react to is your product and your brand. It pays to maintain tight oversight of your suppliers
, and not just for compliance
Tuesday, 18 June 2019Charles Murphy, Cloud and Customer Success Leader, IQVIA Quality Compliance Solutions
With the advent and continuing adoption of new technologies such as cloud computing, big data, and artificial intelligence, deeper and lasting relationships at both the consumer and enterprise levels have become necessary to achieve successful business outcomes. Customer Success is the term used to describe this paradigm shift in the business world, reminiscent of the transformation last seen when IT became a value driver, in addition to a core function, within organizations.
Customer Success focuses on helping customers achieve their business objectives by optimizing the customer experience and customer satisfaction through innovative products, excellent service delivery, outstanding support, and reliable operations service levels.
Tuesday, 11 June 2019Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System
(QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.
In a global industry environment that is constantly evolving, it is apparent that a new approach is required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.