ER/ES regulations Overview and Shimadzu Total Support | Introduction

ER/ES regulations^* demand the reliability of electronic records and electronic signatures. A computer system validation (CSV) is a precondition for the use of electronic records. However, do you really know where to start with the large number of instruments in the laboratory?

* "ER/ES regulations" is a generic term for the regulations and policies on electronic records and electronic signatures, such as FDA 21 CFR Part 11 and the ER/ES policies adopted in each country (including the Japanese version of Part 11).

• Electronic Records and Electronic Signatures (ER/ES)

• Computer System alidation (CSV) Information

To comply with the regulations, simply selecting an appropriate system is not sufficient. Besides the system functions, various operational requirements must be fulfilled. This includes the establishment and documentation of management and operational procedures. The establishment of company policies and a validation master plan at the customer's premises are extremely important.

■ Shimadzu Total Support
Network systems and other Shimadzu products incorporate the functions demanded by the GXPs for ER/ES regulations and computer system validation. Compliance with ER/ES regulations can be extended to all analytical instruments in the laboratory, including chromatographs, spectrophotometers, total organic carbon analyzers, thermal analyzers, particle size analyzers, and electronic balances.

Shimadzu offers a comprehensive support system that provides detailed support throughout the entire system lifecycle, from consultations before system introduction and subsequent periodic inspections to system upgrades. This support includes creating system operation and management procedures, supplying the latest information related to ER/ES regulations, organizing seminars, and training after system introduction.

• Product Range with Guaranteed Data Reliability
Security, audit trail, and integrity functions provide complete support for ER/ES regulations, centered on the network system.

• Validation Support
Support for creating system operation and management procedures required for regulatory compliance, and systematic validation.

• Support for Supplier Evaluations
Support for supplier evaluations (including audits), based on extensive worldwide sales records.

• Support for Activities Related to Regulatory Compliance
Consultation throughout the system lifecycle, including drafting validation plans.