Regulatory audits
- OSHA process safety management compliance audits
- EPA risk management program compliance audits
- Inspections by regulators and insurers
Compliance Audit Automation
Compliance audit automation software for manufacturers
Every audit starts with the same scramble: find the records, prove the training, chase last year's findings. Agnotic Technologies builds compliance audit automation software that maps each requirement to its evidence and collects that evidence from your systems before the auditor asks.
Requirements mapped to controlsEvidence collected from systemsFindings to closureTime-stamped audit trail
Trusted by global innovators
What is compliance audit automation software?
Compliance audit automation software keeps a plant ready for regulatory, certification and customer audits. It maps each requirement to the controls and records that prove it, collects that evidence from your systems on a schedule, and tracks every finding to a documented, closed response. Agnotic Technologies builds it for manufacturers.
The point is to test compliance continuously, so an audit becomes a review of evidence that is already in one place.
Audit types
Which audits can one evidence library serve?
Many requirements overlap, so one piece of evidence often answers several audits.
Certification audits
- ISO 9001 quality
- ISO 14001 environmental
- ISO 45001 occupational health and safety
- Internal audits between certification visits
Customer and supplier audits
- Customer quality and social compliance audits
- Supplier questionnaires and self-assessments
- Second-party audits you run on your suppliers
Electronic records
- 21 CFR Part 11 controls for FDA-regulated records
- Access reviews and audit trail checks
- Record retention and backup tests
Data model
How does a requirement connect to its evidence?
Six layers, each stored once and linked, so a change to a requirement shows every control and record it touches.
Requirements
- Clauses from regulations, standards and customer contracts
- Version and effective date for each
- Owner per requirement
Controls
- The procedure, check or system setting that meets the requirement
- One control mapped to many requirements
- Control owner and test frequency
Evidence sources
- Training system, CMMS, QMS, document control and ERP
- Shared drives and email, where nothing better exists yet
- Manual uploads with a reviewer
Tests
- Automatic checks on a schedule, such as overdue calibrations or expired training
- Sample-based reviews by people
- Pass, fail or exception per test run
Findings
- Raised by tests, internal audits or external auditors
- Response, owner, due date and proof of correction
- Linked back to the control that failed
Audit packs
- Evidence for an audit scope collected into one read-only pack
- Previous findings and their closure
- Export for auditors who work outside the system
Evidence map
Which evidence can be collected automatically?
A sample of the evidence map built with your compliance team. Where no system holds the record, the software asks the owner for it on a schedule.
| Requirement area | Evidence auditors ask for | Where it usually lives | How it is collected |
|---|---|---|---|
| Training and competence | Training records for people in covered roles | Learning management or HR system | Scheduled pull, with expired training flagged as a test failure |
| Equipment and calibration | Calibration and inspection records, overdue items | CMMS or calibration system | Scheduled pull of due and completed work |
| Document control | Current approved procedures and change history | Document control or QMS | Version and approval check against the controlled list |
| Corrective actions | Response to each prior finding and proof of correction | QMS or this software | Linked directly to each finding |
| Electronic records | Access lists and audit trail reviews | ERP, MES, LIMS and other GxP systems | Periodic export and a reviewer sign-off |
| Process safety | Previous compliance audit reports and responses | Shared drive or EHS system | Uploaded once, then tracked by the software |
The map is your own. We build the connectors and tests for the rows your systems support and a request workflow for the rest.
What do we build into compliance audit automation software?
Modules for the evidence layer, connected to the systems that already hold your records.
Requirements library
Regulations, standards and customer requirements as versioned clauses with owners.
Control mapping
Each control mapped to every requirement it meets, so one test serves several audits.
Evidence connectors
Scheduled pulls from training, CMMS, QMS, document control and ERP systems.
Continuous tests
Automatic checks that turn missing or expired evidence into findings before an audit.
Findings and responses
Owners, due dates, documented responses and proof of correction for every finding.
Document review assist
AI that reads uploaded procedures and records and suggests which requirement they answer, for a person to confirm.
Audit trail
Time-stamped records of who created, changed or approved each item, without overwriting earlier entries.
Auditor workspace
Read-only access to an audit pack for internal and external auditors.
Audit pack
What goes into an audit pack?
Built from the evidence library for one audit scope, not assembled by hand the week before.
- The requirements in scope and the controls mapped to them
- Current evidence for each control, with its date and source
- Test results since the last audit, including failures and exceptions
- Previous audit findings, the documented response and proof of correction
- Open findings with owners and due dates
- The audit trail for every change to the pack
Facts and sources
Facts behind compliance audits
Rules that set how often audits run and what must be kept, each linked to its primary source.
Under the OSHA process safety management standard, 29 CFR 1910.119(o), employers must certify at least every three years that they have evaluated compliance, using at least one person knowledgeable in the process, and a report of the audit findings must be developed.
Source: 29 CFR 1910.119(o) (eCFR)29 CFR 1910.119(o)(4) and (5) require the employer to promptly determine and document a response to each compliance audit finding, document that deficiencies have been corrected, and keep the two most recent compliance audit reports.
Source: 29 CFR 1910.119(o)(4) and (5) (eCFR)EPA's risk management program rule, 40 CFR 68.79, requires a compliance audit at least every three years, and requires the next audit to be a third-party audit after an accidental release meeting the criteria in 68.42(a) or when the implementing agency requires one.
Source: 40 CFR 68.79 (eCFR)21 CFR 11.10(e) requires secure, computer-generated, time-stamped audit trails that record operator entries and actions that create, modify or delete electronic records, without obscuring earlier entries, kept as long as the records themselves.
Source: 21 CFR 11.10(e) (eCFR)
Failure points
Why do audits still turn into a scramble?
The patterns we see before a plant automates, and what the software changes.
Challenge
Evidence lives in five systems and a shared drive.
Agnotic approach
Connectors pull it into one library, with the source and date kept on each record.
Challenge
The same evidence is gathered again for every audit.
Agnotic approach
Controls are mapped once to all the requirements they meet, so one record answers many audits.
Challenge
Last year's findings were answered, but nobody can prove they were fixed.
Agnotic approach
Each finding needs a documented response and proof of correction before it closes.
Challenge
Gaps are found by the auditor, not by the plant.
Agnotic approach
Scheduled tests flag missing or expired evidence as soon as it happens.
Challenge
Spreadsheets get edited and nobody knows what changed.
Agnotic approach
An audit trail records every change without overwriting earlier entries.
Standards
Which rules and standards does it cover?
29 CFR 1910.119(o)40 CFR 68.7921 CFR Part 11ISO 9001ISO 14001ISO 19011
Scope
What decides the size of a compliance audit build?
We do not publish prices. These are the drivers we price on the scoping call.
Requirement sets
How many regulations, standards and customer requirement sets are in scope.
Evidence systems
How many systems hold evidence and what interfaces they offer.
Automatic tests
How many controls can be tested automatically, and how often.
Sites
One plant or several, with shared or separate controls.
Electronic records rules
Whether Part 11 or similar controls apply to the software itself.
Migration
Existing audit history and findings to bring across.
Who it is for
Who uses compliance audit automation software?
Manufacturers that face many audits a year from many directions.
Chemical and process plants
Process safety and risk management audits on a three-year cycle, plus certification audits.
Food, drug and device makers
Regulated records, customer audits and certification audits from one evidence library.
Contract manufacturers
Frequent customer audits that ask for the same evidence in different formats.
Multi-site groups
One control framework, with evidence and findings reported per site.
Engagement
How does a compliance audit automation project run?
We start from the next audit on your calendar.
1.
Scoping call
We review your audit calendar, requirement sets, where evidence lives and how findings are tracked.
Scope2.
First release for one audit scope
A fixed-scope first release: requirements, controls, evidence connectors and findings for one audit scope.
Build3.
More scopes and tests
More requirement sets, more automatic tests and more sites, with support after launch.
ScaleFrequently Asked Questions
A QMS runs quality processes such as documents, nonconformances and CAPA. Compliance audit automation sits above it and other systems, mapping requirements to controls and pulling evidence from all of them, including the QMS.
Yes. A control is mapped once to every requirement it meets, so a calibration program can answer ISO 9001, a customer requirement and an internal policy with the same evidence.
No. It collects evidence, runs the tests you define and shows gaps. Your compliance team and the auditors make the judgments.
We build time-stamped, computer-generated audit trails that do not overwrite earlier entries, as 21 CFR 11.10(e) describes. Validation of the system for your use is planned with your quality team.
Yes. Internal and external auditors can get read-only access to an audit pack, or receive an export if they work outside the system.
We do not publish prices. Requirement sets, evidence systems, automatic tests, sites and migration decide the size, and we agree a fixed first release on the scoping call.