美国强生(Johnson & Johnson)成立于1886年，是世界上规模最大，产品多元化的医疗卫生保健品及消费者护理产品公司。据《财富》和《商业周刊》97年公布的结果，强生公司市场价值指标评比名列全球第20位，并位居全美十大最令人羡慕的公司之列，1999年全球营业额高达275亿美元。强生在全球60个国家建立了250多家分公司，拥有约11万5千余名员工, 产品销售于175个国家和地区。
强生公司是世界上最具综合性、分布范围最广的卫生保健产品制造商、健康服务提供商。公司创建于1886年，产品畅销于175个国家地区，生产及销售产品涉及护理产品、医药产品和医疗器材及诊断产品市场等多个领域。
在医疗器械领域，强生包括：女性健康护理、糖尿病、微创手术、伤口缝合、心脑血管健康、骨骼健康、器械消毒、诊断类产品及服务。
Camstar已在强生众多医疗器械领域实施了医疗器械套件MES系统，并实现了对DHR的全面管理和全球化多工厂部署。
以下是强生Vistakon公司Camstar升级项目最佳实践总结。
A Job well done
The Camstar Medical Device Suite 5.8 upgrade project was a huge success. The project was delivered seamlessly with no downtime, on budget and ahead of schedule.
The success of this upgrade was due to a strong partnership between Vistakon & Camstar upgrade teams who planned and executed the upgrade strategy flawlessly.
Project Scope:
1. Upgrade the InSite 3.4 application to the Camstar Medical Device Suite 5.8. This included upgrading both designer and web application.
2. Replace the custom 3.4 Print solution with an off the shelf print module.
3. Create a custom database purge script to purge the MES transaction database.
Success story, why?
1. A strong partnership exists between the Camstar & Vistakon Project teams. The Camstar upgrade team was always available to resolve any issues with the upgraded code which included through testing.
2. Bi-weekly meeting between Camstar and Vistakon project managers to track project progress.
3. The Camstar team had access to the Vistakon transaction database for testing the upgraded code. They were able to test the upgraded code before delivering to Vistakon. The team did not wait for the upgrade to finish to start testing. Instead, the team started testing while the upgrade was in progress. Camstar delivered a beta version of the upgraded MDB code for testing. This helped identify issues earlier in the process.
4. Monthly consultations with the Camstar Services group proved to be very beneficial. Issues with the upgraded code were promptly resolved during consultation sessions.
5. Technical knowledge and understanding of Camstar product by Vistakon team was beneficial to the success of the project.
Brief History:
Vistakon selected the off the shelf MES solution InSite 3.1 from Camstar in 2002. It was customized to add functionality that was not available in the core package such as detain, clear detain, checklist, ESignature etc. These functions were later added in the future releases of Camstar core package.
In 2007, InSite 3.1 was upgraded to version 3.4 and extended by adding additional functions supported by various home grown applications. All the interfaces with external IT systems were absorbed in MES such as interface with SAP, Labs system, Quality system, shipping system etc. A major achievement was interfacing MES with the control system through middleware Archestra system from Wonderware. Thus Vistakon, Vision Care became the first fully automated plant within JnJ and paved way for other JnJ facilities to follow and replicate our success.
The major benefits of replacing home grown application with Camstar InSite 3.1
solution were:
1. Our IT systems were now FDA part 11 complaint
2. Costly paper work was automated which saved money and reduced human entry errors
3. Increased user efficiency by automating manual process functions
4. Improved logging allows process monitoring in real time and the retrieval of audit trail data to track failures
Reason for upgrade:
In 2013, management decided to upgrade to latest version of the Camstar Medical Device Suite 5.8. The reason for upgrading from 3.4 to 5.8 were:
1. The InSite 3.4 application reached the end of its service life by Camstar. This raised the cost to maintain the application.
2. A major break down at our facility would have incurred significant revenue loss.
3. Our infrastructure was aging. We were using Oracle9i database to store manufacturing data and were running Camstar services on Windows 2003 server. The internal IT team had recommended moving to new infrastructure but InSite 3.4 did not support Oracle 11g and Windows 2008 server. By upgrading, we moved to a more mature infrastructure that has improved transaction times thus increasing users efficiency.
Benefits of upgrade:
1. Improved label printing speed. We replaced custom 3.4 label print module with an off the shelf print solution.
a. The old solution took 30 minutes to print 40 labels. Now it is almost instantaneous thus improving printing times by 90%. This allows faster packing & shipping times
b. The new print solution simplifies the creation and printing of new label designs without making code changes. This will play a very crucial part during new product launches by letting us deploy solutions speedily.
2. Taking advantage of upgrade, we worked with Camstar to develop a purge utility for our facility. This purge utility will improve transaction execution time by 40%. Again, in J&J we are the first company which will be purging our database by removing old obsoleted records (check with Camstar).
3. Our middleware application Archestra needed an upgrade but our Control Engineers team could not upgrade the application in isolation because of the dependencies on InSite, therefore, Archestra was also upgraded. This upgrade has enabled the user to be more productive due to better transaction execution times & logging capabilities.
4. An improved audit trail. The new version provides more audit trail information out of box. After deployment due to better audit trail, I can now solve support issues on the manufacturing line by reviewing the audit trail and finding out gaps.
5. A major benefit of upgrade is that now we can add functionality using new product features as well as replace current functionality. We are working on adding resource management, device capabilities, and task lists into our current application.
Upgrade Challenges:
Challenges when interfacing Camstar 5.8 with Control’s middleware application Archestra.
1. In the InSite 3.4 application, Camstar proxy DLL was imported to Archestra to call Camstar transactions using web services. This import was failing in the new version and the vendor suggested compiling Camstar DLL with some additional flags. This was a major show stopper so the team discussed the issue and decided to create wrapper and import the wrapper in Archestra. This averted our first major road block.
2. The older version of Archestra was not set up to connect to a domain server. After the upgrade, the new server and Archestra client communications were failing. An investigation identified the issue and was resolved by connecting the Archestra server to domain controller.
3. Camstar needed Vistakon’s transaction database for testing. One of the challenges was how to set up this database in Charlotte. Vistakon used Camstar Transaction Tester tool to create a modeler script. This script was delivered to Camstar who used it to generate test data. It saved time by not having to install the database and copying the data into it.
4. Since this upgrade involved upgrading the control side, a migration to production could not be completed until the Camstar and Archestra interface is tested on a live production line. This required line time which is difficult to obtain.
5. This upgrade required at-least a 72 hour window of downtime to complete. Because this would impact production, the upgrade was scheduled during the Thanksgiving holiday to deploy the solution.
6. A major challenge was the inability of printing 2D bar codes by the upgraded MES application. Worked with Services group to work out a solution thus averting a major issue
Final Words:
Overall a success story and lessons learnt from this upgrade will be helpful in future projects related to upgrades. Our customers are happy because the execution times have improved and more functionality readily available out of box can be added to make this application more compliant & user friendly.
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