SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
Windows ClearCase has a couple of very useful environment variables - CLEARCASE_PRIMARY_GROUP and CLEARCASE_GROUPS. These variables can be a bit confusing at first blush, but they turn out to be rather important for controlling access to VOB elements, and creating...
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Have you noticed that Rational ClearQuest 7.0 now comes with a new default Eclipse client? Wonder what is happening to the old Windows client and what the difference between the two is? Then this post is for you! Download the attached PDF file below to get the...
SPK helps a tech manufacturer to increase security and availability of its CAD systems and data by moving them to the cloud—while helping them to save $30k per year. The Client A well-known maker of power distribution units for IT racks and related equipment...
BackgroundA diversified medical device company has a leading position in the global endoscopy device space. In this market, the company generates growth and differentiates its products primarily through incremental innovations and investment in research and...
Background Apublicly traded medical device manufacturer with 33,000 employees and several international locations approached SPK and Associates for assistance in streamlining their validation processes. The validation process took months, but the customer wanted...
How SPK successfully improved a client’s engineering productivity and quality by creating a connected business system, leveraging separate, complementary platforms. Bridging TechnologiesMedical device manufacturing is a highly regulated industry. Even the slightest...
BOSTON – Dec. 20, 2022 – PTC (NASDAQ: PTC) today announced that Lawrence Livermore National Laboratory (LLNL) used its Creo computer-aided design (CAD) and Windchill® product lifecycle management (PLM) technology throughout the development of the National Ignition...
Over the years, Lifetime’s products have continued to grow more complex. With a focus on innovation and continuous improvement, the manufacturer recognized the need to digitize and standardize its engineering and manufacturing workstreams. Paper-based processes and...
Formula One: An Audacious Goal When the Volkswagen Group’s premium automaker AUDI AG made the decision to enter the sport of Formula One (F1) racing for the first time, announced at the 2022 Belgian Grand Prix and targeting the 2026 season, it immediately faced...
Nidec Global Appliance is one of the biggest motors producing groups in the world. Its main goal is to deliver the highest standards of quality, competitiveness, and energy efficiency. In this case study, you will learn how PTC Windchill was utilized to achieve...