ConductCompliance for GMP

Watch GMP practice. Record every decision.

Cameras check the practices your procedures require, from gowning and glove changes to personnel flow and material handling. A reviewer decides each case, and your quality unit signs the reports FDA may ask to see.

Request a walkthroughSee what it can watch
GMP workspace, sample data
The review queue in the GMP workspace, with sample cases waiting for review. Each case shows a drawn evidence frame, the condition, what the camera saw and when.
The review queue. Sample data.

What it can watch

Written rules for the practices on your floor

Six conditions run in the demo today. The condition library adds 19 more, and 13 further requirements from 21 CFR 211, FDA guidance and EU GMP Annex 1 describe things a camera can check. Each condition is added with its own rule, cameras, limit and detector, and cites the regulations behind it.

Running in the demo

  • Moving too fast in the filling room
  • Components loaded incorrectly at the infeed
  • Reaching over open containers
  • Gloves not disinfected before sterile handling or between glove ports
  • Component bag touching the hopper
  • Gowning step missed or out of order
See each rule and its sources

In the condition library

  • Interventions

    • Grade A intervention not on the approved list, or not recorded
    • Jam cleared without sterile tools
    • Gloves not disinfected before a grade A intervention

  • Gloves

    • No glove change when moving between filling lines
    • Gloves changed or sanitized just before glove sampling
    • No glove change after touching the floor
    • No glove change after surface disinfection
    • No glove change before unloading the autoclave

  • Gowning

    • Goggles or face touched after gowning
    • Skin exposed after gowning
    • Hands not sanitized before gloving, or gloves donned out of order
    • Disinfectant sprayed onto the garment

  • Disinfection

    • Surface disinfection technique not followed
    • More wipe strokes than the site limit
    • Wipe pattern not unidirectional

  • Personnel flow

    • Leaning on equipment
    • More people in the gowning room than its limit
    • Door opened with gloved hands
    • Two people through one door opening

More requirements a camera can check

  • 21 CFR 211 and FDA guidance

    • Number of people inside the aseptic processing room at one time
    • A person entering a limited-access area
    • How often people enter and leave the aseptic processing room and its critical area
    • How much operators move next to the critical area
    • Component boxes or bags stored on the floor, or without spacing

  • EU GMP Annex 1

    • Both airlock doors open at the same time
    • Grade A and B gowning worn while working in a grade C area
    • Inspector breaks and time at the station during visual inspection
    • A watch, jewelry or a phone in the cleanroom
    • A garment inspected before and after gowning
    • Items inspected on removal from the autoclave
    • People leaving grade B through the change room meant for entry
    • Hands touching vials at the capping station

How it works

From a camera view to a signed record

Four steps, each with a person in the loop where a decision is made.

  1. Detect

    A detector on your monitoring computer checks each camera view against a written rule and opens a case with a short clip.

    Read more about detect

  2. Review

    A trained reviewer confirms, dismisses or escalates the case with a reason. Only a quality lead closes an escalation.

    Read more about review

  3. Sign

    Reports for any week or month become controlled records: a quality review, then approval by a second person.

    Read more about sign

  4. Answer FDA

    Build a records package, show records read-only in an inspection, draft a 483 response and count the Field Alert Report clock.

    Read more about answer fda

What your team hands over

Documents your quality unit can sign and send

Each one comes out of the records it describes. PDFs carry document control and sign-off blocks; spreadsheets stay unlocked, with field definitions.
Page 1 of an Aseptic Behavior Monitoring Report: document ID, revision, approved status, period, purpose and scope.
Aseptic Behavior Monitoring Report, page 1. Sample data.
Page 1 of an Audit Trail Review for August 2026: document control, the chain check result, the sequence range and the hashes before and at the end of the period.
Audit Trail Review, integrity check. Sample data.
Page 2 of a Regulatory Traceability Report: Part 11 clauses, each with its quote, what the software does, what your procedures cover and where to see it.
Regulatory Traceability Report, Part 11 clauses. Sample data.

  • Aseptic Behavior Monitoring Report

    PDFXLSXCSV

    Every detection and decision for a week, month or date range, with trends, escalations, the audit trail and signatures.

  • Event record

    PDF

    One case: what the camera saw, the rule and its sources, and every decision, ready to attach to a deviation.

  • Audit trail and audit trail review

    PDFXLSXCSV

    Every decision with a SHA-256 hash chain, and a review report for any period with an integrity check and exceptions.

  • Electronic signature register

    PDFXLSX

    Every signature with its meaning, signer, time, revision and data fingerprint, and whether it is current or superseded.

  • User access review

    PDF

    Who can get in, each person's role, and what each role may do, printed from the table the software enforces.

  • Records request package

    ZIP

    An index keyed to FDA's items, the records for the period and a SHA-256 checksum for every file.

  • Form FDA 483 response kit

    DOCXPDF

    An editable response letter and signed monitoring evidence for each observation linked to a monitored condition.

  • Validation package

    ZIPDOCXXLSX

    Validation plan, requirements, risk assessment, system description, IQ, OQ and PQ scripts and templates for the rest.

  • Regulatory traceability report

    PDFXLSX

    Every Part 11, Part 211 and Annex 11 requirement, quoted, with what the software and your procedures each do.

  • Change control record

    PDF

    Every release with its changes, the functions it touched and which tests to repeat before use.

Built on the regulations

The passages behind each rule, quoted word for word

Regulators ask for regular observation of aseptic behavior and for records that show who did what, and when. Every quote links to the official text.
“Aseptic operations (including APS) should be observed on a regular basis by personnel with specific expertise in aseptic processing to verify the correct performance of operations including operator behaviour in the cleanroom and address inappropriate practices if detected.”
Annex 1, clause 8.19(opens the official source)EU GMP Annex 1 (2022)Checked 24 Sep 2026
“Supervisory personnel should routinely evaluate each operator’s conformance to written procedures during actual operations. Similarly, the quality control unit should provide regular oversight of adherence to established, written procedures and aseptic technique during manufacturing operations.”
FDA aseptic guidance, page 17(opens the official source)FDA guidance, nonbindingChecked 24 Sep 2026
“Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information.”
21 CFR 11.10(e)(opens the official source)Binding US regulationChecked 24 Sep 2026
“Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.”
21 CFR 211.100(b)(opens the official source)Binding US regulationChecked 24 Sep 2026
requirements mapped to what the software and your team do
60
21 CFR Part 11 clauses, each quoted
17
EU GMP Annex 11 clauses, each quoted
18
monitored behaviors, each with its sources
6

Read them clause by clause: 21 CFR Part 11 and EU GMP Annex 11.

Free for any GMP team

Tools and references you can use today

No account needed. They work whether or not you use the software.

Validation

Validation starts from drafts

10 Word drafts, a traceability matrix and a regulatory report, all generated from one specification of the system. Your team reviews, runs and signs them.
system functions, each rated for risk
14
user requirements, each traced to its source
29
IQ, OQ and PQ test scripts
29
Word drafts in the package
10

See what is in the validation package

Where it runs

Footage stays on your network

At your site

Cameras, the monitoring computer that runs the detectors, and the clips and frames they record. Cases cite each clip by ID, so the footage never has to leave your network.

In the workspace

Cases, decisions, signatures, reports and exports. Where the workspace runs, and how people sign in, is set up with your IT team.

Questions

Common questions

Is it only for aseptic processing?
No. The first detectors cover aseptic processing, where regulators ask most directly for observation of how people work. The same review, audit trail, signatures, reports and FDA tools apply to every condition you add, such as gowning, glove changes, disinfection, personnel flow and material handling. Each condition is added with its own rule, cameras, limit and detector.
Is the software Part 11 compliant?
Part 11 applies to the company that keeps the records, so compliance comes from validated systems plus your procedures and training. The software gives you the controls Part 11 describes, such as audit trails, signature details and authority checks, and the documents your team needs to validate them. Your quality unit decides.
Does video leave our site?
Clips and frames stay on your network. Each case cites its clip by ID, and your team can show any clip on screen or provide a copy when asked.
Who decides whether an event is a violation?
A trained reviewer, every time. The detector opens a case; a person confirms, dismisses or escalates it with a reason, and a quality lead closes each escalation with an outcome.
Which regulations do the rules cite?
Each rule cites its site procedure and the passages behind it from EU GMP Annex 1, FDA's guidance on sterile drugs produced by aseptic processing and 21 CFR Part 211, quoted word for word with links to the official texts.
How do we validate it?
Start from the validation package: 10 Word drafts, a traceability matrix and a regulatory report. Your team reviews and approves them, runs the IQ, OQ and PQ scripts, and signs the summary report before GMP use.
Can we see it before we talk about a pilot?
Yes. Request a walkthrough and we will show the workspace with sample data, including the documents it produces.

See it with sample data

We show the review queue, a signed monitoring report, the audit trail review and the validation package, then answer your team's questions.

Request a walkthrough