A1 AuditGxP & Quality Audit Management

HomeUse Cases

Use your own applicable source

One audit workflow for every applicable requirement.

A1 Audit can support external regulations, quality standards, internal SOPs, supplier requirements and custom questionnaires. You decide what applies; the app keeps the questions, evidence, report and follow-up connected.

Choose a requirementChoose an audit type

What are you auditing against?

GMPGDPGLPHACCPANVISA-basedInternal SOPSupplierCustom

What type of audit are you conducting?

InternalSupplierWarehouseLaboratoryFood safetyOperational

Regulations, standards and internal requirements

Choose the requirement you are auditing against

Open one section for the unique application. The operating instructions remain in the existing Workflow Guides.

GMPManufacturing and pharmaceutical-quality auditsQuality systems, production, facilities, equipment, documentation and data integrity.

Best suited for

Internal GMP audits, supplier or manufacturer audits and focused system reviews.

Typical areas

Quality systemProductionFacilitiesDocumentationData integrity

Example

Select the applicable equipment and documentation questions, capture objective evidence during the site audit and produce a traceable report.

Regulation LibraryCommon workflow
GDPStorage, transport and distribution-quality auditsWarehousing, temperature management, transport, returns and traceability.

Best suited for

Warehouse, transport-provider and distribution-service audits.

Typical areas

StorageTemperatureTransportReturnsTraceability

Example

Build a focused warehouse scope, record the observed controls and supporting records, then carry the same evidence into the Draft and Final Report.

Select the scopeReports
GLPLaboratory quality and data-integrity auditsRaw data, samples, methods, equipment, calibration and controlled procedures.

Best suited for

Laboratory process, documentation, equipment and data-integrity reviews.

Typical areas

Raw dataSamplesMethodsEquipmentCalibration

Example

Link document references, observations and evidence to the questions that apply to a selected laboratory process.

Findings and evidenceDocument capture
HACCPFood-safety and preventive-control auditsFood handling, temperatures, allergens, cleaning, hygiene and monitoring records.

Best suited for

Hospitality, food-handling and food-production quality audits.

Typical areas

TemperatureAllergensCleaningHygienePest control

Example

The Harbour Table Café example demonstrates a HACCP-style audit from the source through evidence, report creation and trend review.

Open the HACCP exampleConduct the audit
ANVISAANVISA-based audit and inspection-readiness preparationSource-based question selection, evidence gathering and traceable reporting.

Use it for

Preparation based on current, applicable ANVISA source material selected by the user.

Important

A1 Audit is not approved or endorsed by ANVISA and does not determine which requirements apply.

Example

Turn the relevant source into a focused question set, capture readiness evidence and produce a reviewable report.

Regulation LibraryUser responsibility
SOPInternal SOPs and company standardsCompany procedures, local policies, internal controls and recurring audit programmes.

Best suited for

Internal quality reviews where company-controlled requirements define the expected practice.

Typical sources

SOPsPoliciesWork instructionsLocal standards

Example

Create or import the questionnaire, select the scope for this audit and reuse the source for future audits.

Use your own sourceSelect questions
SUPSupplier requirements and qualification standardsSupplier questionnaires, agreements, technical expectations and oversight programmes.

Best suited for

Initial qualification, routine oversight and targeted supplier follow-up.

Typical sources

QuestionnairesAgreementsSpecificationsService controls

Example

Combine the relevant supplier requirements into one audit scope and keep each observation connected to its source question.

Create the auditCapture evidence
CUSCustom questionnaires and mixed audit programmesImport your own questions or create them from an uploaded regulation, SOP or other controlled source.

Best suited for

Hybrid audits, internal controls and organisation-specific reviews that do not fit one named regulation.

Flexible scope

Custom questionsMixed sourcesInternal SOPsFocused reviews

Route 1

Import questions with the Excel template

  1. Open Dashboard → Regulation Library.
  2. Open the Excel import option and download the template.
  3. Add the source structure and audit questions to the workbook.
  4. Upload the completed file, review the imported content and approve it before use.

Route 2

Upload a source and generate questions

  1. Open Dashboard → Regulation Library.
  2. Upload the applicable regulation, SOP or controlled source document.
  3. Use the question-generation flow to create draft audit questions.
  4. Review, edit and approve every question before selecting it for an audit.
Professional review is required.Imported or generated questions are working content. The end user remains responsible for accuracy, completeness, applicability and alignment with the source.
See the detailed import stepsSee the common workflow

Audit activities

Choose the audit job you need to complete

The same core flow supports different audit activities. Open a card for the distinct purpose and suggested guides.

Internal auditsReview your own processes, SOPs and quality system.

Use a controlled internal source, select the relevant process and create a separate audit record for each review.

Start with Audit setup
Supplier auditsAssess manufacturers, laboratories, warehouses or service providers.

Combine supplier expectations with the applicable regulatory or quality requirements and retain the evidence against each question.

Open Findings and Evidence
Warehouse and distribution auditsStorage, temperature, transport and traceability.

Build a focused scope around facility and distribution controls, then generate the report through the standard workflow.

See the GDP use case
Laboratory auditsProcesses, raw data, equipment and controlled documentation.

Use document references and objective evidence to keep laboratory observations traceable.

See the GLP use case
Food-safety auditsHACCP, hygiene, allergens and preventive controls.

Use question-linked observations, photographs and monitoring records during the site visit.

See the café example
Operational and custom auditsLocal controls, hybrid standards and focused reviews.

Start in Dashboard → Regulation Library. Either download and complete the Excel template, or upload the regulation, SOP or source document and generate draft questions. Review and approve the content, then create the audit and select only the questions needed for the operational scope.

Compare the two source routesOpen the detailed guide

Professional responsibility remains with the user

A1 Audit organises the audit—it does not determine compliance.

The user remains responsible for source applicability, scope, evidence assessment, findings, conclusions, report review and follow-up.

Read the intended-use explanation