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实例探究 > Kley Hertz enhances processes, guarantees information security and boosts productivity with SoftExpert

Kley Hertz enhances processes, guarantees information security and boosts productivity with SoftExpert

技术

应用基础设施与中间件 - 数据交换与集成
功能应用 - 企业资源规划系统 (ERP)

适用行业

药品

适用功能

质量保证

用例

过程控制与优化
监管合规监控

服务

系统集成
培训

挑战

Although it has a document management process spread across all areas, management of this process was done manually. All documents implemented at Kley Hertz were updated in a master list controlled using an Excel spreadsheet, which was also used to control the expiration of documents. Control of documents under revision was cumbersome and there was no way to control how long a document remained with each responsible party (creator, consensus and approval). This caused delays in approvals and greater involvement of Quality Assurance at each step of the process and in asking the areas to return documents. Considering the large amount of documents that the company has, expiration control was not applied to all documents. According to Márcia Valiati, Technical Manager at Kley Hertz, it was impossible to know which documents were most accessed and revised and they only became aware of new versions after e-mails were sent. In addition, watermarks were manually added and documents were converted into PDF format in order to make them available electronically for consultation. The texts had no keyword search, which demanded time for research.

关于客户

Kley Hertz is one of the 10 largest Brazilian-owned OTC pharmaceutical companies. It has a portfolio of over 60 medication brands, including Over-the-Counter medicines, herbal remedies, supplements, cosmetics, dermocosmetics and prescription medications, producing and distributing over 20,000,000 units annually. Its factory has Good Manufacturing Practice – GMP certification, guaranteeing that the company meets all pharmaceutical industry standards required by law for the manufacture of medications.

解决方案

In light of this situation, Kley Hertz began a detailed assessment process to adopt an electronic management solution for its documents and records, considering the strict regulatory and validation requirements for systems that the pharmaceutical industry must have. At the end of the process, the SE Document solution was selected. This product is part of a suite of applications for enhancing processes, regulatory compliance and excellence in management, provided by SoftExpert Software. As differentials, Valiati points to the traceability and security of SoftExpert solutions. 'We consider the software to be educational and its parameters can be set according to the company's need,' she adds. SE Document is part of the collaborative workflow technologies, such as indexing, recovery and visualization of content, in a single web application. The software allows for simple and immediate access to documents by the company's departments, customers and suppliers, assuring that up-to-date versions are available. In addition, all actions executed in relation to the documents throughout their life cycle are 100% monitored.

运营影响

With the SoftExpert solution, Kley Hertz has enhanced the traceability of its processes and regulatory compliance with electronic management of documents and records.
The organization currently manages processes and over 10,000 documents electronically, with operational and productivity gains.
The solution serves 273 registered users, allocated to the Production, Quality Control, Quality Assurance, Research and Development, Engineering, Environment and Logistics areas, in addition to Administrative areas such as HR, Marketing, Sales, Finance and IT.

数量效益