Terms of Service

1. Agreement to Terms

These Terms of Service ("Terms") govern access to and use of the ComplianceWorxs website and services (collectively, the "Services"). By using the Services, or by purchasing an IRR or an Inspection Response Decision Record, you agree to these Terms.

If you use the Services for an organization, you represent that you are authorized to act for that organization. You also represent that you are authorized to submit the information and materials you provide to ComplianceWorxs.

2. Description of Services

ComplianceWorxs provides a guided decision-record service for regulated life-sciences teams. The Services help preserve, organize, and present the available record behind a completed consequential GMP decision.

The Services may include:

• Inspection Response Records (IRRs);
• the Inspection Response Decision Record, a self-service product described in Section 4;
• a decision-specific Case File included with an IRR purchase;
• the Decision Documentation Assessment (DDA) and the One-Decision Test;
• illustrative Samples and Case Files;
• educational content and decision-record resources; and
• AI-assisted tools used to support preparation of the Services.

3. Inspection Response Record (IRR) Service

The standard IRR purchase is $497 for one completed consequential GMP decision, unless a different price or scope is displayed at checkout.

The customer provides the completed decision and available supporting materials. ComplianceWorxs organizes the available facts, evidence, judgment, alternatives, risk acceptance, rationale, and authorization history into a reviewer-ready Inspection Response Record.

A decision-specific Case File may be included with the IRR purchase at no additional charge. The Case File provides supporting context for that IRR. It does not create a separate regulatory determination or approval.

The IRR reflects the materials made available to ComplianceWorxs. ComplianceWorxs does not independently verify every underlying fact. It does not create missing source evidence or certify that the customer's source records are complete.

3A. Case Files

3A.1 What a Case File is. A Case File is an educational and illustrative worked example. It shows how the evidence, judgment, risk, alternatives, and authorization behind one type of GMP decision can be documented. A Case File is offered at $149 unless a different price is displayed at checkout, or is included with an IRR as described in Section 3. The facts, names, products, batches, dates, and references in a Case File are fictional or composite unless it states otherwise. A Case File does not describe, and is not, a record of any customer's, person's, or company's actual decision.

3A.2 What a Case File is not. A Case File is not legal, regulatory, quality, validation, or compliance advice. It is not a template or standard that any regulator has accepted or that will satisfy any legal or regulatory requirement. It is not a regulatory determination. It does not make, approve, recommend, or replace any GMP decision, and it is not a record of the customer's own decision or an authoritative quality-system record. The customer's own decisions must be made and documented by its own qualified personnel under its own procedures and quality system.

3A.3 No reliance. The customer's use of and reliance on a Case File, and any interpretation, adaptation, or presentation of its content by the customer or by anyone to whom the customer provides it, is at the customer's own risk and responsibility. ComplianceWorxs does not warrant that a Case File is complete, current, accurate for the customer's circumstances, or suitable for any regulated purpose. ComplianceWorxs is not responsible for any conclusion drawn or action taken from a Case File.

3A.4 Private access and license. Where ComplianceWorxs provides a Case File through a private link, the link, the online edition, and any PDF are licensed to the purchasing customer, identified on the Case File as the licensee, for internal quality, compliance, audit, training, and business purposes only. The customer must not resell, republish, post, or distribute a Case File or its link outside its organization, and must not share a link to get around access limits. Access is limited to a set number of browsers or devices, may require confirmation of the purchaser's email address, lasts for the period stated when the link is issued (currently 90 days), and may be suspended or withdrawn under Section 15. ComplianceWorxs may record access events, including a keyed hash of the network address, to administer these limits. A PDF carries the licensee's name and order reference.

3A.5 Agreement before access. Before a private Case File opens, the customer is asked to agree to these Terms. ComplianceWorxs records that agreement with the version of the Terms and the time. A person who agrees on behalf of an organization represents that they are authorized to bind it.

3A.6 Fees and no refunds. Case File fees are payable at checkout. Case File purchases are final and non-refundable. This does not limit any refund or remedy that applicable law requires.

4. Inspection Response Decision Record (Self-Service Product)

4.1 What it is. The Inspection Response Decision Record (the "Decision Record") is a self-service workspace and document-export tool. It is offered at $1,500 for one decision, unless a different price or scope is displayed at checkout, and only to a customer who has completed an IRR for that decision. It lets the customer organize, label, and preserve what the customer's own sources support about one decision.

4.2 Prepared, reviewed, and approved solely by the customer. ComplianceWorxs does not prepare, review, verify, edit, approve, certify, or endorse the content of any Decision Record. Every statement, evidence reference, provenance designation (Contemporaneous, Subsequently Corroborated, Retrospective, or Unresolved), state assignment, identification of an authorizer, and attestation in a Decision Record is entered, selected, or confirmed by the customer and is the customer's own assertion. Only the customer organization can review and approve its Decision Record, and it alone does so. ComplianceWorxs personnel will not review a Decision Record unless the parties separately agree in writing.

4.3 Content carried over from an IRR. Findings and context carried over from an IRR are a starting point only. They are not approved statements. The customer must review each item and confirm, correct, or remove it before relying on it.

4.4 Historical integrity. The customer must not present information created after the original decision as though it existed at the time of the decision, and must identify retrospective entries as retrospective. "Unresolved" is a permitted and final state. A Decision Record does not create, restore, or prove documentation that did not exist at the time of the original decision.

4.5 Attestation. To finalize a Decision Record, an individual must attest on behalf of the customer. That individual represents that they are authorized to bind the customer organization, that the Decision Record was prepared, reviewed, and approved solely by the customer, and that the customer accepts these Terms, including Section 13. The attestation and its timestamp concern the Decision Record's own creation, not the original decision. ComplianceWorxs is not a party to, witness to, or verifier of the attestation.

4.6 No advice and no guarantee. The Decision Record is not legal, regulatory, quality, or validation advice. It does not make, approve, or replace the underlying GMP decision. It is not an authoritative quality-system record. ComplianceWorxs does not guarantee that any regulator, auditor, customer, or other reviewer will accept it or that it satisfies any legal or regulatory requirement. The customer determines whether and how to use, retain, or submit a Decision Record and must maintain its own source and authoritative records.

4.7 Finalization and exports. A finalized Decision Record is locked. Corrections require a new version where the workspace provides one. PDF exports are generated from the customer's own entries, and ComplianceWorxs is not responsible for their content or accuracy.

4.8 Fees. Fees for the Decision Record are payable at checkout and are non-refundable once access to the workspace has been provided, except where required by law or where ComplianceWorxs is unable to provide the workspace.

5. Customer Responsibilities

The customer remains responsible for the underlying GMP decision and for all use of the resulting IRR. The customer agrees to:

• provide accurate information and materials it is authorized to share;
• identify material corrections or omissions known to the customer;
• ensure appropriate qualified personnel review the IRR before regulated use;
• maintain required source records and authoritative records in the customer's own QMS or other required systems;
• determine whether and how the IRR is incorporated into internal procedures, investigations, submissions, inspection responses, or other regulated activities; and
• comply with applicable laws, regulations, contracts, confidentiality obligations, and internal procedures.

6. AI-Assisted Processing and Human Review

ComplianceWorxs may use artificial intelligence and other automated tools to organize, summarize, cross-reference, and draft portions of the Services.

Customer content may be processed by third-party technology providers used to deliver the Services, including AI service providers. That processing is subject to applicable contractual, security, and privacy controls.

ComplianceWorxs does not authorize AI systems to make the customer's GMP decision. ComplianceWorxs also does not represent that AI-assisted output is, by itself, a validated regulated record.

7. Regulatory and Professional Boundaries

ComplianceWorxs is not a regulatory authority and does not provide legal advice. Unless separately agreed in writing, the Services also do not constitute regulatory, validation, or compliance consulting advice.

ComplianceWorxs does not guarantee inspection readiness, regulatory approval, or the absence of observations or enforcement action. We also do not guarantee that an inspector, auditor, customer, regulator, or other reviewer will accept an IRR.

The Services do not replace required SOPs, deviations, investigations, CAPAs, change controls, batch records, validation records, electronic records controls, or other authoritative QMS records.

8. Customer Data, Ownership, and Confidentiality

Customers retain ownership of the materials they submit. By submitting materials, the customer grants ComplianceWorxs the limited rights necessary to process those materials and provide the Services.

ComplianceWorxs will treat customer-submitted non-public materials as confidential. We will disclose them only as reasonably necessary to provide the Services, to service providers acting on our behalf, as required by law, or with customer authorization.

Customers must not submit information they are not authorized to disclose. Customers should apply their own internal controls before submitting sensitive or restricted information.

This includes trade secrets, personal information, protected health information, export-controlled information, and information subject to third-party restrictions.

Additional information about data practices is provided in the ComplianceWorxs Privacy Policy.

9. Pricing, Payment, Fulfillment, and Refunds

IRR purchases are processed through Stripe or another payment processor identified at checkout. ComplianceWorxs does not store full payment-card details.

The standard IRR price is $497 for one completed consequential GMP decision. Any different price, discount, scope, or bundle displayed at checkout controls that transaction.

Fulfillment begins after payment and after the customer provides the materials reasonably required to prepare the IRR. Delivery timing may depend on the completeness and complexity of those materials, as well as customer responsiveness.

Because an IRR is prepared for a specific customer decision, payments are non-refundable once substantive fulfillment work has begun. Exceptions apply where required by law or where ComplianceWorxs is unable to provide the purchased Service.

Questions about a purchase should be sent to support@complianceworxs.com.

10. Intellectual Property

ComplianceWorxs retains ownership of its software, templates, methodologies, page designs, prompts, frameworks, educational content, and other pre-existing or reusable intellectual property.

The purchasing customer may use its completed IRR and decision-specific Case File internally for quality, compliance, audit, inspection, transaction, and business purposes. Customer-submitted materials remain the customer's property.

Illustrative Samples, generic Case Files, website content, and ComplianceWorxs methodologies may not be resold, republished, or commercially redistributed without written permission.

11. Security and Service Availability

ComplianceWorxs uses commercially reasonable measures designed to protect customer data and the Services. No system can guarantee absolute security or uninterrupted availability.

ComplianceWorxs may use third-party infrastructure, analytics, payment, communications, and AI providers to operate the Services. Those dependencies may occasionally affect availability.

12. Disclaimer and Limitation of Liability

To the maximum extent permitted by law, the Services are provided on an "as available" basis. ComplianceWorxs does not warrant a regulatory outcome, fitness for a particular regulated purpose, or acceptance by a regulator or third party.

To the maximum extent permitted by law, ComplianceWorxs will not be liable for indirect, incidental, special, consequential, exemplary, or punitive damages.

This limitation also applies to lost profits, lost revenue, business interruption, regulatory findings, product holds, recalls, enforcement actions, and other downstream consequences arising from use of the Services.

ComplianceWorxs' aggregate liability arising from the Services will not exceed the fees the customer paid to ComplianceWorxs during the twelve months before the event giving rise to the claim. A different limitation applies where required by law. ComplianceWorxs has no liability for the content of any Decision Record, which is prepared, reviewed, and approved solely by the customer, or for any consequence of the customer's reliance on it. ComplianceWorxs also has no liability for the content of any Case File, which is an illustrative example, or for any consequence of the customer's or any other person's reliance on, interpretation of, adaptation of, or presentation of it.

13. Indemnification

13.1 Customer indemnity. To the maximum extent permitted by law, the customer will defend, indemnify, and hold harmless ComplianceWorxs and its owners, officers, employees, contractors, and service providers (the "ComplianceWorxs Parties") from and against all third-party claims, demands, investigations, and proceedings, and all resulting losses, liabilities, damages, penalties, fines, judgments, settlements, costs, and expenses (including reasonable attorneys' fees), arising out of or related to: (a) any materials, information, statements, evidence, or provenance designations the customer submits, enters, selects, or attests; (b) the customer's decisions, including the underlying GMP decision; (c) the customer's use of, reliance on, interpretation of, adaptation of, presentation of, submission of, or distribution of any IRR, Decision Record, Case File, or other output, including to regulators, auditors, customers, or transaction counterparties; (d) any representation by the customer that later-created information is contemporaneous, or any other misstatement in a Decision Record; and (e) the customer's breach of these Terms, violation of law, or infringement of third-party rights, including submitting information it was not authorized to share.

13.2 Procedure. The ComplianceWorxs Party will give the customer prompt written notice of the claim. A delay relieves the customer only to the extent it is prejudiced by the delay. The customer controls the defense and settlement with counsel reasonably acceptable to ComplianceWorxs. ComplianceWorxs may participate with its own counsel at its own expense. The customer may not settle a claim in a way that admits fault by, or imposes an obligation on, a ComplianceWorxs Party without its written consent. ComplianceWorxs will provide reasonable cooperation at the customer's expense.

13.3 Exclusion. The customer is not required to indemnify a ComplianceWorxs Party to the extent a court of competent jurisdiction finally determines that the loss was caused by that party's gross negligence or willful misconduct.

13.4 Relationship to other terms. This Section is in addition to any other remedy. The limitation of liability in Section 12 does not limit the customer's obligations under this Section. This Section survives termination.

14. Acceptable Use

Customers may not use the Services unlawfully, submit malicious code, or attempt unauthorized access. Customers also may not misrepresent AI-assisted or illustrative material as a regulator-issued determination, reverse engineer protected portions of the Services, or use the Services to facilitate fraud or deception.

15. Suspension and Termination

ComplianceWorxs may suspend or terminate access for material violations of these Terms, unlawful use, security threats, fraud, nonpayment, or misuse of the Services.

Provisions concerning confidentiality, intellectual property, payment obligations, disclaimers, and liability survive termination where their nature requires it.

16. Governing Law

These Terms are governed by the laws of the Commonwealth of Massachusetts, without regard to conflict-of-law principles. Subject to applicable law, disputes arising from these Terms or the Services will be resolved in state or federal courts in Massachusetts.

17. Changes to These Terms

ComplianceWorxs may update these Terms as the Services change. The current version will be posted on this page with its effective date.

Changes do not retroactively alter a completed purchase unless required by law or expressly agreed by the parties.

18. Contact

19. Decision Coverage and Recurring Billing

Section 9 governs fees for separately purchased Inspection Response Records. Section 19.8 governs Decision Coverage fees, including Inspection Response Records prepared using Included Records.

19.1 Decision Coverage

Decision Coverage is a recurring plan that includes a set number of Inspection Response Records ("Included Records") for each Billing Period. The plans are Individual ($999 per month, 3 Included Records per month) and Team ($2,500 per month, 8 Included Records per month). Organization plans are set in a written order form and governed by it. If an order form conflicts with these Terms, the order form controls.

19.2 Billing Periods and automatic renewal

Coverage starts when your first payment succeeds. Each Billing Period is one month, or 12 months for an annual plan. We charge your payment method at the start of each Billing Period and Coverage renews automatically until you cancel. By completing checkout you authorize these recurring charges. We send a receipt for each charge. For annual plans, we send a renewal reminder at least 30 days before the renewal date.

19.3 Annual prepay

You may pay for 12 months in advance at the published annual price, which equals ten months of the monthly price. Included Records are made available each month. Annual fees are non-refundable except as stated in 19.8. An annual plan renews for another 12 months unless you cancel before the renewal date.

19.4 Included Records

Included Records are added at the start of each month. Unused Included Records carry over while your Coverage is active and expire when your Coverage ends. An Included Record is used when you start an Inspection Response Record. A record that fails to prepare and is retried counts once. Included Records have no cash value and cannot be transferred.

19.5 Cancellation

You may cancel at any time from your billing portal or by emailing support@complianceworxs.com. Cancellation takes effect at the end of the current Billing Period. You keep access to your Included Records until then, and we make no further charges after it takes effect. There is no fee to cancel.

19.6 Changing plans

A change to a different plan takes effect at the start of the next Billing Period unless we agree otherwise in writing.

19.7 Price changes

We may change plan prices with at least 30 days' written notice. A new price applies from the first Billing Period that begins after the notice period. You may cancel before it takes effect.

19.8 Refunds

Fees are non-refundable once a Billing Period has begun, and we do not refund part of a Billing Period when you cancel, except (a) where the law requires, (b) where we fail to provide Included Records you paid for, or (c) as stated in 19.12. A person at ComplianceWorxs reviews every refund request and answers in writing.

19.9 Failed payments

If a payment fails, we may retry it and will notify you. If the failure is not resolved within 14 days, we may end your Coverage, and unused Included Records expire. You may start a new plan at any time.

19.10 First-record credit

If you buy a single Inspection Response Record and start Decision Coverage within 30 days of that purchase, we credit $497 toward your first month. The credit applies once per customer, has no cash value, and is applied through a promotion code we provide.

19.11 Prepaid bundles

Prepaid Inspection Response Record bundles purchased before the date they were withdrawn remain valid for 12 months from purchase on their original terms.

19.12 Changes and discontinuation

We may change or discontinue Decision Coverage with at least 30 days' notice. If we discontinue it, we refund the unused portion of any prepaid fees.

19.13 Taxes

Prices exclude applicable taxes. We add taxes at checkout where required.

19.14 Regulated decisions

Decision Coverage preserves the record behind your decisions. ComplianceWorxs does not make, approve, or recommend regulated decisions. Your organization and its authorized personnel remain accountable for them.

19.15 Governing law

These provisions are governed by the laws of the Commonwealth of Massachusetts, without regard to conflict-of-law rules. Disputes are subject to the state and federal courts located in Massachusetts.