Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
PDM/PLM-Product Data and Lifecycle Management
Using IBM Rational Packaging Utility
In this post, we talk about how to use IBM Rational Packaging Utility along with Installation Manager to first create an installation package containing multiple products (in this case ClearCase and ClearQuest 7.1.2, and License Key Administrator 8.1.1). Then we will...
CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends
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...
Using Windows ClearCase Variables – CLEARCASE_PRIMARY_GROUP and CLEARCASE_GROUPS
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...
Computer System Validation: A Closer Look at 21 C.F.R. §820.70(i) and FDA Warning Letters
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Using the New ClearQuest Eclipse Client
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’s vCAD Solution Increases Productivity, Security, and Savings
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...
The Power of the Cloud – Med Device Company Boosts Operational Efficiency and Customer Satisfaction
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...
Leading Medical Device Company Achieves Major Efficiency Boost by Utilizing SPK’s SolidWorks CSV Expertise
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...
Improving Accessibility and Accuracy of Engineering Documents Via a Cloud-Based SolidWorks to MasterControl Connector
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...
EnerSys Speeds Time To Market with Windchill SaaS
EnerSys is an industrial technology leader serving the global community with mission-critical stored energy solutions that meet the growing demand for energy efficiency, reliability, and sustainability. They are dedicated to providing people everywhere with accessible...
Optimizing Solidworks PDM Implementation
When multiple employees of a Fortune 100 medical equipment manufacturing company reached out to us for support with workflow functions and permissions, we knew there was a better way. Rather than fixing the issues that would inevitably keep occurring with their...