GMP Deviation Approved Scope Dategap Tool

Description

Test process membership and eventDay inside the inclusive approval window, then combine those flags with approved for eligible.

Good manufacturing practice records connect materials, actions, people, and source evidence. A local check can expose missing or inconsistent metadata, but it cannot authenticate a record or replace quality-system review.

Test process membership and eventDay inside the inclusive approval window, then combine those flags with approved for eligible.

When to use this tool

Use GMP Deviation Approved Scope Dategap when you need a literal manufacturing-record or source-support diagnostic.

How to use the tool and how it works

Enter process, approvedProcesses, eventDay, approvalDay, expiryDay, approved. Use the units and conventions below.
Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
Read scopeMatch, effective, leadDays, eligible. Inspect scopeMatch, effective, eligible before interpreting the associated values.

Require expiryDay no earlier than approvalDay. Test process membership and eventDay inside the inclusive approval window, then combine those flags with approved for eligible.^[1]

Input field	Meaning and units	Accepted input
process	Process	Required. Text; maximum UTF-16 length 8192.
approvedProcesses	Approved Processes	Required. Array of text; maximum UTF-16 length 8192; maximum items 256.
eventDay	Event Day	Required. Safe integer.
approvalDay	Approval Day	Required. Safe integer.
expiryDay	Expiry Day	Required. Safe integer.
approved	Approved	Required. Boolean.

Output field	Interpretation	Returned shape
scopeMatch	Scope Match	Required. Boolean.
effective	Effective	Required. Boolean.
leadDays	Lead Days	Required. Safe integer.
eligible	Eligible	Required. Boolean.

json

{
  "input": {
    "process": "P",
    "approvedProcesses": [
      "P"
    ],
    "eventDay": 110,
    "approvalDay": 100,
    "expiryDay": 120,
    "approved": true
  },
  "output": {
    "scopeMatch": true,
    "effective": true,
    "leadDays": 10,
    "eligible": true
  }
}

Limitations and assumptions

Numeric dates, approval scope, and approval status are supplied; eligibility under these flags does not validate a deviation, authorize work, or establish regulatory compliance.
Inputs must satisfy both the field types and the cross-field conditions above. Invalid input causes an error; a successful false flag or documented placeholder is a different result.
Numeric calculations use binary floating point unless exact decimal-integer arithmetic is explicitly stated. No hidden measurement tolerance or decimal rounding is added; nonfinite or out-of-contract results are rejected. Numeric signed-zero results are exported as zero.

Alternative or Complementary methods

Use the controlled record system to verify identity, provenance, approvals, and complete audit history. Treat local flags as prompts for investigation rather than release or compliance decisions.

References

Calculation and input contract: gmp/gmp-deviation-approved-scope-dategap — tool.io

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