Computerized System Validation (CSV)

Computerized System Validation

In the ever growing life sciences landscape, the dependence on computer systems has increased, thereby requiring the validation of these systems. 1STEP has experts that work with our clients to validate the entire computer systems from a simple PLC based system to a complex enterprise level applications like ERP Applications

1STEP has the knowledge and experience to help the customers assess and define their compliance and validation requirements.

Our dedicated pharmaceutical and computer systems division are uniquely qualified to optimize any validation effort by applying quality validation services and the most current technology

Comprehensive GAP & RISK Analysis
Most appropriate & latest GAMP, 21 CFR Part 11, EU Annex 11 guideline based Compliance services for your new / legacy systems
Validate Laboratory Equipment Software, IT systems, Network validation as per GAMP
Validate Building Management & Environment Control Systems
Validate DCS / SCADA / PLC Based Systems
Database Systems including ERP such as SAP & LIMS
Equipment validation
Technical support during regulatory compliance audits

IT Infrastructure Qualification

IT Infrastructure Planning
IT Infrastructure Audits
Data Center Audits
Developing IT procedures and policies

System Administration
Security
User Management
Data and Application Backup and Restoration
Document Management
Configuration Management
Release Management
Preventive Maintenance

Spreadsheet Validation

Spreadsheets are used extensively by several departments of Life Sciences companies to perform or support GxP regulated activities, thereby requiring these spreadsheets to be validated.

1STEP Works provides both documentation and execution support for spreadsheet validation.