FDA has recently issued a draft guidance document on an approach for deciding when to submit a 510(k) for a software change to an existing device. This guidance applies to software subject to premarket notification requirements (510(k)s).  Such software may either be part of a medical device or in itself a medical device (standalone medical device software or Software as a Medical Device - SaMD).

The objective of this white paper is to provide a literature survey and supplemental information to detail the limitations, applicability and value associated with the use of process capability indices (i.e., Cpk, Ppk) for demonstrating the manufacturing process capability within the pharmaceutical industry.

"When it comes up in conversation with friends, family and clients, people are regularly amazed when they learn how long I have been with Protocol Link - recently I celebrated my 15 year anniversary with the company.  When I take time to reflect, I believe that I have found an organization that shares my values and passion to provide excellent guidance and service to our clients.  Our motto of Process Done Right is reflected in how frequently we work with the same clients and how often they recommend us to others.  We subscribe to a hands on approach to help drive successful implementation, not just give advice. This is how we bring success to our clients.  In this dynamic industry, we see clients return over time when new challenges arise for their company, when they move to another company and find unexpected challenges, or to connect us with a colleague that they believe we can help.

Protocol Link always works as a team. You may just have a small team of us on-site, but the entire team is always there in the background, ensuring that each task has the attention of an expert to provide the best technical or regulatory guidance available."