Digitising pharmaceutical quality management for an API manufacturer in Ahmedabad. WildMind designed and built AC-QMS: a custom, ICH Q7-compliant Quality Management System modelled on the company’s real documents and workflow, replacing paper files and disconnected Word/PDF processes with a controlled digital system.
Aditya Chemicals, an API (Active Pharmaceutical Ingredient) manufacturer in Ahmedabad, runs a disciplined, regulator-aligned quality process under ICH Q7 / IP standards. Every batch must move through Specification, Method of Analysis, Analysis Worksheet, and Certificate of Analysis, with each step performed, checked, and signed.
That process was compliant and well-run, but managed entirely through paper and disconnected files: Word documents, PDFs, and physically stamped “Master Copy / Controlled Copy” printouts. The discipline lived in people’s habits, not in a system. As the company grew its product range and customer base, that manual foundation was becoming a bottleneck and a rising compliance risk.
Each document was prepared, checked, and approved by hand. Nothing guaranteed that approvals couldn’t be skipped, roles signed in the right order, or that the same person couldn’t both perform and check their own work. Two-person verification was enforced by discipline alone.
Analytical results (Assay, Loss on Drying, elemental impurities) were calculated by hand, including interdependent formulas such as Assay corrected for Loss on Drying. Slow, and real risk of error in the numbers that decide whether a batch passes or fails.
The same product identity, test parameters, limits, and procedures were re-entered across the Specification, Method of Analysis, worksheet, and Certificate, for every batch. Documents constantly fell out of agreement with one another.
Reconstructing a batch’s full history (who did what, when, what changed, and why) meant assembling physical files. An audit trail that lives in filing cabinets is slow to produce and hard to guarantee complete.
Approved documents, especially Certificates of Analysis and Specifications, need to reach the right people, including customers, in a controlled way. There was no system-level record of what was shared, with whom, and when.
Every new product, customer variant, and batch multiplied the manual effort. Global QMS platforms were prohibitively expensive; domestic tools were too basic to enforce genuine ICH Q7 discipline. Growth turned the paper process into a liability.
WildMind built AC-QMS: a purpose-built digital Quality Management System modelled on Aditya Chemicals’ actual documents and workflow. Required approvals, correct signing order, and the two-person rule are guaranteed by the software. Product identity and analytical specifications are defined once and flow automatically into every downstream document and batch.
Every action is recorded in a tamper-proof audit trail. Approved documents are locked and snapshotted; any change is governed by formal change control. Each user sees and does exactly what their role permits. These principles are built into the foundation of the system, not bolted on afterward.
Each product’s identity is captured once in a Product Master, and its analytical specification (tests, limits, methods) is defined in a reusable Specification Template. This eliminates the repeated re-entry that caused documents to drift apart.
AC-QMS drives the analytical chain, Specification → Method of Analysis → Analysis Worksheet → Certificate of Analysis, as a controlled sequence. Each document is prepared, checked, and approved by the correct roles in the correct order, and the system prevents steps from being skipped.
Analytical results are computed from entered raw values, including interdependent formulas such as Assay corrected for Loss on Drying. The system does the arithmetic and independently re-checks results rather than trusting entered totals. Out-of-specification results are flagged and blocked from silent approval.
Downstream documents are generated from data already in the system. The Certificate of Analysis is produced automatically from the signed worksheet, carrying the correct results, compliance verdict, and full signature lineage, formatted to the manufacturer’s own document standards.
Role-based access governs who can create, approve, and view each document. Approved documents can be delivered to the right people, including customers, in a controlled way, with a record of what was shared and when.
Every document carries its revision history, effective dates, and status. Changes to approved documents are governed by change control, and every controlled action is written to an immutable audit trail, making the system audit-ready at any moment.
AC-QMS mirrors real pharmaceutical quality roles with precisely scoped permissions, so compliance is structural, not aspirational.
System and product administration: configuration, user management, and master data governance.
Analytical testing execution and first-line quality approval within the controlled document chain.
Quality assurance oversight, final signature authority, and release governance across the workflow.
Controlled access to released documents for customer-facing needs, with sharing logged and auditable.
WildMind delivered AC-QMS on a modern, maintainable technology foundation. We work in disciplined, verifiable increments: each part of the system is built, tested, and confirmed before the next begins, so quality is designed in from the first line, and the client always has visibility into progress.
Approvals, the two-person rule, document locking, and the audit trail are foundational, not bolted on. The system enforces what regulators require, rather than relying on individual discipline.
Product identity and analytical specifications flow forward automatically into every downstream document and batch, eliminating the re-entry that caused documents to fall out of agreement.
Interdependent analytical formulas are computed and independently verified by the system. Out-of-specification results are flagged before they can be silently approved.
Every controlled action is written to an immutable audit trail. Reconstructing who did what, when, and why no longer requires assembling physical files.
Genuine ICH Q7 compliance without the cost and complexity of multinational QMS platforms, purpose-built for how Aditya Chemicals actually operates.
New products, customer-specific specifications, and batches are handled without multiplying manual effort. The core system is built to extend: reporting, integrations, and additional capabilities layer onto the same solid base.