"SoftExpert Document guarantees that the document management process is reliable, traceable and dynamic. This is of the utmost importance at a company like ours, where compliance with procedures and standards is essential to the success of the business."

Challenge

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.

The Solution

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 SoftExpert 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.

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.

SoftExpert 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.

The Results

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.

"Today, we have around 10,000 documents, including current and obsolete documents, stored on the system," says Valiati.

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.

Among the gains obtained with SoftExpert Document, Valiati mentions involvement of areas and agility across the document approval process. "This has facilitated control of revisions by Quality Assurance and allowed for greater compliance with demands," she says.

Keyword searches in the body of documents, awareness of which documents are most accessed and management of the document expiration period were also highlighted by Valiati.

"SoftExpert Document guarantees that the document management process is reliable, traceable and dynamic. This is of the utmost importance at a company like ours, where compliance with procedures and standards is essential to the success of the business," she sayes.

SoftExpert Differentials:

• Low complexity implementation
• Great cost-benefit relationship
• Integrated components
• 100% web-based