Fuji Xerox Supports Pharmaceutical, Medical, and Cosmetic-Related Corporate Customers in Complying With the Pharmaceutical Affairs Act and Improving Work Efficiency
Launches Enhanced Functions of Apeos PEMaster Evidence Manager 2.3
November 7, 2012
TOKYO, November 7, 2012 — Fuji Xerox Co., Ltd. begins offering a document management solution and its advisory services today with the enhanced functions of Apeos PEMaster Evidence Manager 2.3, the software that securely records and manages evidence created during work and in commercial transactions. The enhanced functions ensure the authenticity of managed records and supports customers in complying with a range of requirements designated by the Pharmaceutical Affairs Act.
To assist corporations in the pharmaceutical, medical and cosmetic industries that need to comply with the Act, Fuji Xerox offers has enhanced its document management solution. In addition to the existing record management and work progress tracking functions offered by Apeos PEMaster Evidence Manager 2.3, the following functions are now available to ensure the authenticity of the records used, particularly in pharmaceutical, medical equipment, and cosmetics corporations.
- Proves the authenticity of the workflow approval process by combining the approver's proof of identity together with an electronic signature.
- Audit evidence can be easily viewed when a need arises for speedy troubleshooting for operational errors and others.
With these enhanced functions, Apeos PEMaster Evidence Manager 2.3 offers a document management system that complies with both ER/ES Guidelines published by the Pharmaceuticals and Food Safety Bureau, Ministry of Health, Labor and Welfare of Japan, and Food and Drugs Administration Title 21 of Code of Federal Regulations Part 11 (FDA 21 CFR Part 11Note1) designated by the US Food and Drug Administration. Additionally, Fuji Xerox also offers related advisory services upon customer request. These new functions will create an accurate and efficient record management system by supporting the entire process—from computer system validation (CSVNote2) to system operation and maintenance, thereby not only meeting the legal requirements but also optimizes the user's business procedures.
Further, using the Apeos PEMaster series, multifunction devices, and Denshi-Pens in combination with Apeos PEMaster Evidence Manager 2.3 reduces paper usage as well as establishes a smooth flow of record creation and management in both paper and electronic formats.
Utilizing the expertise of document utilization and management that Fuji Xerox possesses as its forte, the company will continue to offer solutions to comply with a variety of regulations while improving business operation efficiency.
The Pharmaceutical Affairs Act stipulates requirements to ensure the efficacy, safety, and quality of drugs, quasi-drugs, cosmetics and medical instruments. Pharmaceutical, medical equipment, and cosmetics corporations must comply with the ordinances to realize Good x Practice (GxPNote3, such as the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-Drugs—Good Management Practice (GMP) ordinance—, and the Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-Drugs, Cosmetics, and Medical Devices—Good Quality Practice ordinance.) Corporations are also required to manage designated documents during their business processes, including designing, manufacturing, quality control, and inspection, and retain such documents so that they are traceable by auditors.
However, storage and searching of such documents have become a burden for corporations as the types and quantity of documents are increasing due to the growing complexity of business processes in recent years. Many corporations are seeking to convert their documents to electronic formats in order to manage them more efficiently. They often struggle to do so as many of the documents have specific formats to be completed by hand, and electronic format data must meet the requirements of the guidelines for electronic records and electronic signatures (ER/ES Guidelines).
Fuji Xerox will establish a system that improve efficiency and usability of document/record creation and storage taking account of legal compliance and document validity.
Fig.: Document management solution with the new enhanced functions of Apeos PEMaster Evidence Manager 2.3 to comply with the Pharmaceutical Affairs Act
- Requirements designated by the US Food and Drug Administration (FDA) on electronic documents/records submitted by pharmaceutical and related companies when applying for sales permission in the United States.
- Recording and storing system-related activities from development to operation in order to ensure the validity of the computer system. Must be conducted adhering to the Guidelines on the Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-Drugs published by the Ministry of Health, Labor and Welfare, Japan.
- Criteria established by the government and public bodies to ensure the safety and reliability of products.
|Product Name||Number of License||List Price (before tax)||Scope|
|Apeos PEMaster Evidence Manager Basic Package License 2.3||Single server license||3,000,000 yen||Permits a single server installation|
- In order to build this document management solution to comply with the Pharmaceutical Affairs Act, optional services such as modules, client access license, advisory service, and others are required.
Only in Japan