That 21 CFR Part 11 requires electronic signatures to be linked to their respective electronic records?
Improving Your QMS
Most medical device companies recognize the importance of an effective QMS for regulatory compliance and competitive advantage. Here is a step-by-step approach on how to improve your system.
By John Gagliardi
"Death by CAPA"
Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process can be so overwhelming for some firms that an FDA official called it "death by CAPA."
Especially for Medical Devices
Less than a year after the FDA's new donor screening and testing regulations became effective, there were 77 HCT/P deviations reported. So, it was not much of a surprise that the agency recently issued a guidance pertaining to certain HCT/Ps.
Especially for Blood / Biologics
How to Solve the Top Five Complaint-Handling Challenges
Consumer complaints are at the heart of every product recall. Whether it's Merck's voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints.
The reporting of side effects or adverse events is incorporated in FDA regulations. The agency operates MedWatch, a safety information and adverse-event reporting program that allows health-care professionals and the public to report serious problems associated with medical products.
While there is no denying the importance of customer complaints for life science companies, many organizations find it difficult to implement a process that will effectively manage, report, and resolve complaints. The following are some of the most common complaint-handling issues faced by FDA-regulated companies and practical tips on solving them.
Five Things You Should Expect from a Compliance Software Vendor
By Jim Murrin
The advent of JetBlue's Customer Bill of Rights has increased public awareness about the consumer's fundamental right to get his or her money's worth. Whether you're buying an airline ticket or a car, you should know what you can expect from the seller.
Let's apply this concept to life science companies purchasing software for managing the content derived from their GxP processes. In the February issue of this newsletter, we discussed the things that a life science end user should consider, namely:
- Does the application answer the end user's needs?
- Does the vendor have the domain expertise, adequate technical and financial resources, and philosophy to deliver a successful solution?
- Are the end user's evolving needs and the vendor's long-term development plans aligned such that the partnership will endure?
I recently had the privilege of visiting several life science customers to ask them what they expect from us as a solution supplier. They were surprised that a vendor would ask such a question. The fact that a vendor would adjust its programs to maximize the customer's return on investment was novel to them. Read more.