Information Technology
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Using Run and Control Charts to Understand Variation
Quality improvement experts around the globe know that a picture is worth a thousand words. Instead of relying on complicated and confusing data tables, we prefer to make a picture of the data and let the picture do the... -
Validation and Control of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
Validation and Control of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to ensure... -
Validation of Excel Spreadsheets in GxP Environment
Areas Covered in the Session : 21 CFR Part 11 compliance of a computer system Electronic Records & Electronic Signatures How to develop GxP compliant spreadsheet applications Learn how to use Excel’s built in 21 CFR Part 11 features... -
Virtual Site Audits for FDA Regulated Industries
How can this little used internal inspection tool — “virtual” site cGMP-compliance audits — be used to assist in FDA regulatory compliance, and in meeting requirements for cGMP system audits / inspections of vendors, other remote located sites. Each... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,... -
Project Management for Computer Systems Validation
Description: This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new... -
Computerized System Validation: Basic Concepts
Description: Test Areas to be Covered: Test Who will Benefit: Test -
Systems Validation Made Easy
Description: This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new... -
Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements
Description: 21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to... -
Project Management for Computer Systems Validation
Description: This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new... -
Computerized System Validation: Basic Concepts
Description: Test Areas to be Covered: Test Who will Benefit: Test -
Systems Validation Made Easy
Description: This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new... -
Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements
Description: 21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to...
