Batch Release Spreadsheet Remediation

Reference Architecture: The blueprint for converting a pharmaceutical lab's calculation spreadsheet into a validated, 21 CFR Part 11 compliant application.

The Archetype: The "Potency Calculator"

In our extensive experience with SAP implementations across the pharma supply chain, we frequently encounter a persistent artifact of "Shadow IT": The Critical Spreadsheet.

A typical example is the "Potency Calculator."
While the core ERP (SAP) manages inventory, the actual release decision often relies on an Excel workbook living on a shared drive. Lab technicians input raw HPLC data, and the spreadsheet applies density corrections and standard curve adjustments to determine if a batch passes or fails.

While the math is usually correct, the infrastructure is fundamentally non-compliant.

The Compliance Gap

When we audit these legacy tools against current FDA expectations (specifically Data Integrity and ALCOA+), four critical risks emerge:

  1. No True Audit Trail: Excel tracks "last saved by," not "who changed cell B4." If a technician overwrites a failing result, the forensic history is lost.
  2. Unprotected Logic: Critical formulas often rely on cell protection that is easily bypassed.
  3. Versioning Chaos: There is rarely a guarantee that the technician is using the approved v4.0 file versus an outdated local copy.
  4. Lack of Input Validation: A simple typo (text in a number field) can break downstream calculations or, worse, yield a plausible but incorrect result.

The Risk: Releasing a sub-potent batch due to a calculation error or undetected data manipulation.

The Solution: The ValidKeep™ Approach

The ValidKeep remediation strategy does not simply "copy" the spreadsheet; it treats the Excel file as a User Requirement Specification (URS) to engineer a deterministic software solution.

Here is the Reference Implementation for remediating this specific class of risk:

Phase 1: Logic Extraction & Hardening

We begin by isolating the business logic from the user interface. In the "Potency Calculator" scenario, we extract the density correction variables.

  • The Upgrade: Instead of hard-coding variables in a hidden cell, we move them into a Validation Control Matrix. This ensures that parameters like "Specific Gravity" become managed configuration items that require Quality Unit approval to change.

Phase 2: The "Frozen" Build

The application is deployed on the ValidKeep Hub, inheriting enterprise-grade security controls by default:

  • Identity: Access is tied to the client's Identity Provider (e.g., Okta/Azure). Anonymous access is impossible.
  • WORM Logic: The calculation engine is immutable. The user inputs variables, and the system returns a protected result. The user cannot alter the math.
  • Signature: To release the batch, the system enforces a "Step-Up Authentication" (password re-entry), creating a 21 CFR Part 11 compliant electronic signature linked to that specific data row.

Phase 3: Automated Verification (The Robot)

Manual validation of complex logic is error-prone and slow. ValidKeep utilizes Automated Operational Qualification (OQ) agents.

  • The Method: Our "Robot" runs hundreds of test scenarios against the build, including edge cases (e.g., "What if density is 0?", "What if input is negative?").
  • The Evidence: The system automatically generates a Traceability Matrix and a Validation Summary Report containing embedded screenshots of every passed test.

The Target State

By migrating the "Potency Calculator" from Excel to ValidKeep, the organization moves from a state of risk to a state of control:

  1. Immutable Evidence: Every calculation generates a unique ID stored in a Cryptographic WORM Vault. The data cannot be deleted or altered by the user or IT.
  2. Confirmatory PQ Capability: To address recent regulatory concerns regarding "Software Validation," the system includes a "PQ Mode." This forces the user to verify the software calculation against a manual check during the initial production runs, creating the "Confirmatory Testing" evidence required by auditors.
  3. Lifecycle Management: The client no longer manages file versions on a shared drive. The application becomes a "Frozen Artifact": locked, versioned, and centrally hosted.

Conclusion

The transition from Excel to a validated platform transforms a liability into an asset. It allows the Quality Director to present a Defensible Position during an audit: a system that is secure, traceable, and validated by design.