Excel Spreadsheets and FDA Device Regulations
Excel Spreadsheets and FDA Device Regulations
Dan O'Leary CBA, CQA, CQE, CRE, SSBB, CIRM President
Ombu Enterprises, LLC Dan@
603-209-0600
Excel Spreadsheets & FDA Regulations
Ombu Enterprises, LLC
1
Outline
? Overview of the FDA regulations ? Excel Validation ? Using the Excel Convert Function ? Excel Formula Auditing ? Excel Protection ? Track Changes ? Automated Processes ? Electronic Records (Part 11) ? Summary & Conclusion ? Q&A session
Excel Spreadsheets & FDA Regulations
Ombu Enterprises, LLC
2
Automated Processes for Production or the Quality
System
Scope The Requirements ? 820.70(i) The FDA Guidance Documents
Excel Spreadsheets & FDA Regulations
Ombu Enterprises, LLC
3
Scope
? We are not looking at the purchase of a major software system
? We limit our scope to "homegrown" applications
? A skilled employee builds an application in Excel ? This is analogous to writing a procedure or work
instruction
? The same principles apply if you contract the work
? The manufacturer retains responsibility for validation and system performance
Excel Spreadsheets & FDA Regulations
Ombu Enterprises, LLC
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Our Examples
? We will use two simple examples
? A manufacturer makes a chemical mixture, a buffer, used in an IVD reagent. The recipe, written in an SOP, has a variable quantity depending on production volume. The operator currently calculates the amount of each required component using a calculator. As a preventive action opportunity, a Manufacturing Engineer automates the calculation using a Excel spreadsheet.
? A Quality Engineer automates the disposition information for nonconforming material. The Excel spreadsheet is the start of a system to track the frequency of dispositioned part numbers as part of the CAPA system statistical analysis. The information will also be used for Management Review.
Excel Spreadsheets & FDA Regulations
Ombu Enterprises, LLC
5
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