Excel spreadsheets how to ensure 21 cfr part 11 compliance

Excel Spreadsheets -How to Ensure 21 CFR Part 11 Compliance?

Spreadsheets are a repository for critical data, and for making critical decisions.

In Microsoft Excel, the workbook is the file that the user creates.

Each worksheet contains -calculations, data entry fields, audit trail, and display formats that comprise the application.

What are Spreadsheets?

FDA Expectations for Use of Spreadsheets All spreadsheets containing GxP or quality data must be compliant with 21 CFR 11 and the data within must be controlled.

21 CFR 11.10: Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity & when appropriate, the confidentiality of electronic records, and to ensure the signer cannot readily repudiate the signed record as not genuine.

FDA has stepped up 21 CFR 11 enforcement since late 2010.

Control over system documentation

Accountability of signatures

Training/qualification of personnel

Electronic audit trail

Authority checks

Limited access to systems and data

Accurate and steady retrieval

Accurate and complete copies

Operational system checks

Device checks

Validation

21 CFR Part 11 Requirements

Which Spreadsheets should be Compliant?

Clinical: Research Data, Result Data etc

Spreadsheets that control GxP data Laboratory: Lab Data, Animal Data etc

Manufacturing Data

Documented evidence of SOPs

Spreadsheets used to make quality Tracking Logs:decisions Internal Audits, Approved Supplier Lists, Approved Batches, etc.

QA: Quality Assurance Data

Spreadsheet containing Even if it does not fit the data that will be previous 2 requirements reported to a Regulatory Agency Risk based approaches apply

Best Practices to Comply with FDA Requirements Develop, communicate and enforce a company policy and master plan for spreadsheet calculations.

Prepare an inventory list with all computers that run spreadsheets.

Standardize “development and use� as much as possible.

Protect spreadsheets using built-in standard software and IT infrastructure (e.g., client/server).

Validate spreadsheet calculations.

Document and justify your approach.

Want to learn more about 21 CFR Part 11, its requirements and best practices to comply with them?

ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance • Design and Validation of Excel Spreadsheets: Step-by-Step • Learning from Recent FDA Warning Letters Related to Part 11 • Understanding and Implementing FDA'S 21 CFR Part 11 • How to Comply with 21 CFR Part 11 Requirements for Electronic Medical Records • Computerized System Validation - A Detailed Insight • 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection • Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

To know more on 21 CFR 11compliance visit www.complianceonline.com

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