Cleaning Validation Simplified

Residue Acceptance Limits made Practical, Acceptable & Justifiable

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Separate application for API and FPP customers

Efficient. Affordable. Compliant.

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Harness the power of cloud computing to determine MACO acceptance limits for as many as 500 products in under 30 minutes

eResidue provides end-to-end visibility by bringing together data at the most granular level for your entire site. This single source of truth, while following your company workflow/basis, allows a user to filter information by equipment or product, no matter how complex or large your data set is.

In addition, the ability to simulate and create what-if scenarios on the fly will allow users to test the impact on the limits when there is a change in equipment/product. Since all users are using the same platform, everyone gets to see any changes made or review the same version of calculation report.

Limit Definition Screenshot

Is it not time that your company moved away from spreadsheets?

Though there are add-on modules that can make your spreadsheet meet Part 11 requirements, we would like you to consider the following points:

  • Maintaining 'original data' and 'true copies' is a manual process.
  • As data grows, spreadsheets feel the pressure and often crash. To overcome this, multiple files with smaller data sets are maintained. With multiple "sources of truth", risk of errors increases and one loses the granularity of the data. And inefficiency increases.
  • Spreadsheets are a blank slate. The lack of predefined formulae and algorithms in spreadsheets increases user accountability for the calculated results.

eResidue, with workflow and formulaes vetted by leading cleaning validation experts, manages the process in a central, secure and regulated environment generating efficiency gains.

Calculate Limit Screenshot