Spreadsheet Validation

Situation is…

  1. Many companies have software and spreadsheets that have not been validated but are currently in use.
  2. Has your companies received warnings from the FDA for not being compliant with 21 CFR 820.70(i)?
  3. Ensuring that your spreadsheets are functioning accurately, reliably, and consistently is vital for your own business processes as well as for satisfying your regulatory auditors.

Challenge is…

  1. All automated processes in production and the QMS must be validated for intended use.
  2. Showing documented evidence that your spreadsheets are generating accurate data is imperative.
  3. Spreadsheets that have not been validated or spreadsheets producing inaccurate data can stop your company’s use of Excel spreadsheets or stop your operations completely until the situation is rectified.
  4. Developing a standardized validation SOP and validating all spreadsheets while continuing your use of Excel and satisfying your regulatory auditors.

We provide the solutions you need:

  • Employ our proven, scalable validation process into your own spreadsheets, quality system and throughout your entire company.
  • Risk analysis of your current spreadsheet inventory; identify critical spreadsheets in need of the validation process.
  • Collect and analyze all spreadsheets for compliance to regulatory standards.
  • Develop a standardized validation SOP; fulfilling the requirements of your regulatory auditors and future regulatory standards.
  • Exhaustive intended use analysis of spreadsheets.
  • Editing and reformatting to add good practice measures such as password protection and version control.
  • Comprehensive validation plan and execution that employs newly designed SOP.
  • Systematic training of your team to validation procedures.

AlvaMed has the experience and expertise to provide your company the spreadsheet validation support it needs. Having worked with one of the largest life science companies in the United States on spreadsheet validation, AlvaMed has a breadth of knowledge for the entire process; from developing a standardized validation SOP to accessing spreadsheets for compliance or applying the validation procedure, AlvaMed can provide support in all areas.

For more information: Spreadsheet Validation and 21 CFR 820/13845:2016 Regulations