Tuesday, 19 March 2019Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Risk continues to be a major focus in most businesses today, regardless of industry. In the past few years, Life Sciences organizations have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. Subsequently, the standards organizations and regulators around the globe have taken note and responded accordingly. So it’s no surprise that minimizing business and operational risks, as well as legal and regulatory compliance, is on every executive’s mind, and for good reason.Supplier risk
, put simply, is the probability associated with a supplier causing an interruption in an organization’s supply chain by impacting the availability of products and services within that supply chain. Supplier impact, at a minimum, effects two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: those two legs are Risk and Compliance. The impact of suppliers on an enterprise can be significant.
Tuesday, 12 March 2019Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company
The American Society for Quality, touted as the “Global Voice of Quality,” states that manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs
. As a biopharmaceutical industry veteran, I know the challenge is real. In fact, when illustrating a graphic representation of the Biopharma industry’s information management landscape, as I see it, the depiction is quite dense and complex.
Tuesday, 26 February 2019Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company
An important facet of any organization’s quality efforts is the knowledge of its personnel. The depth of each employee’s knowledge and skills contributes to the company’s ability to achieve its mission and goals. Conversely, employees who do not have the knowledge to perform their day-to-day functions pose a quality risk
. This equation applies as much to long-time employees as to new hires.
Tuesday, 19 February 2019Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company
Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Employee risk management training
is essential to bridging the awareness gap.
With the adoption of ISO 13485:2016, Life Sciences manufacturers have stepped up their risk-based training requirements. What about your organization? How do you currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process.
Tuesday, 05 February 2019Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA companyCorrective and Preventive Action (CAPA)
systems provide a wealth of information regarding the quality
of a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.
For instance, it is not uncommon for a CAPA
to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole.