Ingredient weighing and batching, guided step by step at the station.

Ingredient weighing and batching software with station-guided weighing steps, tolerance checks and electronic dispensing records to replace paper sheets.

Training management linked to your SOPs and roles.

Training management software that links SOPs and roles to a skills matrix, shows who needs retraining after a revision and tracks refresher dates.

Internal audit software that links findings to follow-up.

Internal audit software to plan, run and close GMP and ISO audits, with findings routed to NCR or CAPA for an owner and records exportable for review.

Calibration schedules, records and due dates in one place.

Equipment calibration software to track instruments, schedule calibrations, record as-found/as-left readings and show overdue equipment to your team.

Complaint management that keeps reportability decisions documented.

Complaint management software that links each complaint to the lot, investigation and CAPA, and records your team's reportability decision and rationale.

Document control for SOPs, forms and specifications.

Document control software for SOPs, work instructions, forms and specifications, with versioning, e-signature approval, training links and audit trail.

CAPA software that links each action to its cause and its evidence.

CAPA software that links each corrective action to its source deviation, lot, owner and evidence, with an effectiveness check recorded before your team closes it.

Electronic batch records captured as the line runs.

Electronic batch record software for pharma and supplement makers: weighings, lot checks and sign-offs recorded as the batch runs, then reviewed by exception before release.

21 CFR Part 11 software: audit trails, e-signatures and controlled records.

Software controls that support 21 CFR Part 11: audit trails, electronic signatures and controlled records. Validation and procedures remain your responsibility.

Food safety records for HACCP, FSMA 204 and your next GFSI audit.

Food safety compliance software for HACCP monitoring, FSMA 204 traceability records and audit evidence for SQF, BRCGS and FSSC 22000 schemes.

Supplier quality: approval, CoAs, SCARs and scorecards in one place.

Supplier quality management software for supplier approval, qualification, CoA checks, SCARs and scorecards, linked to receiving, lots and CAPA.

GMP software that keeps people, documents and equipment status in view.

GMP compliance software that brings training status, current documents, equipment status and signed records together on the shop floor.

HACCP software for CCP monitoring, verification and corrective actions.

HACCP software that schedules CCP monitoring, records verification and corrective actions at the line, and keeps the evidence with the plan.

Cannabis ERP for lot traceability, batch records and GMP documents.

Cannabis ERP software for cultivators, processors and manufacturers: lot traceability, batch records, lab CoA review before release and controlled documents.

Deviation management that captures the event when it happens.

Deviation management software that records deviations on the shop floor, links them to the lot and operator, and carries investigation into CAPA.

Validation lifecycle records for computerised systems.

Validation lifecycle software for computerised system validation documents — requirements, IQ/OQ/PQ and traceability. IQ/OQ support is Enterprise only.

Pharmaceutical QMS for documents, training, CAPA, change and audits.

Pharmaceutical QMS software that brings document control, training, CAPA, deviations, change control, audits and supplier quality together.

Change control with impact assessment and signed approval.

Change control software that routes each change through impact assessment, review and training, with e-signed approval recorded before it goes live.

ISO 13485 software for device records, CAPA and complaints.

ISO 13485 QMS software for device manufacturers: device history records, controlled documents, CAPA, complaints, supplier quality and training.

FSMA 204 traceability records captured at each tracking event.

FSMA 204 software that records key data elements at receiving, transformation and shipping, linked by traceability lot code, for sortable spreadsheet export.

Batch record review by exception.

Batch record review software that shows exceptions — missing signatures, out-of-spec readings, deviations and skipped steps — so QA can focus its review.

Environmental monitoring records and trends for controlled areas.

Environmental monitoring software for scheduled sampling, temperature, humidity and pressure readings, with trending and alerts for your team to investigate.

Quality software for CMOs and CDMOs serving several clients.

Quality and manufacturing software for CMOs and CDMOs: organise records by client, share status through a customer portal and confirm separation needs in scoping.

Replacing a legacy QMS: plan the move of documents, CAPAs and training.

Planning to replace a legacy QMS? See how V5 approaches migrating documents, CAPAs, training records and change controls, with a parallel-run cutover.

On-premises QMS and MES on your own servers.

Self-hosted QMS and MES for regulated manufacturers that need data on their own servers or private cloud. See deployment and validation support.

Software controls for EU GMP Annex 11 computerised systems.

Software controls that support EU GMP Annex 11: audit trail review, e-signatures, access control and periodic review. Validation and procedures remain yours.

A 90-day plan to prepare for your next audit.

A phased 90-day plan for bringing document control, CAPA, training, change control and supplier qualification into V5 ahead of an inspection or audit.

OOS investigations with a clear Phase I and Phase II record.

OOS investigation software that structures a Phase I laboratory assessment before any Phase II investigation, with retest justification and signed decisions.

Recall software for mock and real recalls.

Recall management software for mock and real recalls: forward and backward lot tracing, customer lists and effectiveness checks from one record.

Stability studies: pull points, results and specification limits.

Stability study software that schedules pull points, links results to specification limits and helps prepare stability reports for review.

Cleaning validation: limits, sampling plans and verification records.

Cleaning validation software to record limits, worst-case matrices, swab and rinse sampling plans and verification results for your team's review.

Risk files that stay connected to production controls.

Risk management software for FMEA and ICH Q9-aligned risk registers, with risk controls linked to deviations, CAPA and changes.

Label and artwork control with signed approval before printing.

Label and artwork control software with structured review and approval, market-specific variants and a controlled link from approved artwork to printed label.

LIMS connected to production and quality.

LIMS software for sample lifecycle, chain of custody, instrument integration, specification checks and OOS workflow, connected to MES and QMS.

ISO 9001 software that keeps certification evidence together.

ISO 9001 QMS software for document control, internal audits, nonconformity and corrective action, risk and management review evidence.

Data integrity software that supports ALCOA+ records.

Data integrity software that supports ALCOA+ principles across records, audit trails, e-signatures and instrument data, with review built into daily work.

MRB software from hold to documented disposition.

MRB software for nonconforming material: hold, review and disposition (use-as-is, rework, regrade, return or scrap) with e-signatures and lot traceability.

Pharmacovigilance case records and periodic review.

Pharmacovigilance support for adverse event case records and periodic review. Confirm coding, E2B and reporting needs with us before relying on them.

First article inspection records.

First article inspection support for recording characteristics, results and approvals. Confirm AS9102 form needs with us during scoping.

Regulatory submission tracking and commitments.

Track regulatory submissions, correspondence and commitments in one place. Confirm publishing and gateway needs with us during scoping.

Turn scanned paper batch records into reviewable electronic records.

AI-assisted digitisation of scanned paper batch records: extracts entries, signatures and results for human review, keeping the original scan attached.

AI document intake for supplier, customer and lab documents.

AI document intake for POs, CoAs, invoices and certificates: extracts the fields and matches them to orders or lots for a person to confirm.

Ask V5: an assistant for questions about your records.

Ask V5 answers questions about your batches, deviations, CAPAs, SOPs and supplier records within each user's access rights, with links to the source records.

AI drafts for CAPA and deviation investigations, approved by people.

AI drafts CAPA and deviation narratives, candidate root causes and action plans from linked evidence for investigators to review, edit and approve.

Annual product review drafts for QA to review and sign.

AI-assisted annual product review: gathers batch, deviation, complaint and CAPA data and drafts sections for QA to review and sign.

Continued process verification with SPC charts for your team.

Continued process verification support with SPC charts across process parameters and results, and signals assigned to an owner for review.

AI-assisted OOS investigations drafted for review.

AI-assisted OOS and OOT investigations: a guided Phase I and Phase II workflow with evidence linked and drafts prepared for investigators to review.

Regulatory change: what V5 records today.

V5 does not monitor regulator websites. When your team finds a relevant change, change control records the impact assessment, approvals and actions.

Supplier scorecards built from what actually happened.

Supplier scorecards built from receiving, CoA, delivery and complaint records, with AI-drafted explanations of score changes for buyers to review.

Cost variance review during the month, not only at close.

COGS variance review: standard versus actual cost per batch, lot and SKU, with drill-down to the batch or PO for your finance team.

Material planning scenarios for demand and supply changes.

Material planning support for demand, supplier and capacity changes, with reorder suggestions from real consumption for planners to approve.

Formula checks on materials, allergens and cost before the first batch.

AI-assisted formula drafting and checks on material availability, allergens and cost for R&D and operations teams to review.

Label proof checks for your regulatory team to sign off.

Label proof review support that compares proofs with approved formula and label data and lists differences for your regulatory team to decide on.

A daily operations brief for each site, linked to source records.

An AI-drafted daily brief covering production, quality and supply, with every item linked to its source record for the morning meeting.

Pharmaceutical manufacturing from dispensing to QA release.

Pharmaceutical manufacturing software for dispensing, electronic batch records, in-process checks, deviations and the QA release queue.

Food safety management for HACCP plans, CCP monitoring and prerequisites.

Food safety management software for HACCP plans, CCP monitoring, prerequisite programmes, corrective actions, audits and FSMA records.

Food traceability from receipt to dispatch.

Food traceability software that records lot-level data at each tracking event, with one-up/one-back genealogy, mock recalls and FSMA 204 export.

User access management for accountable GxP records.

User access management for GxP sites: individual accounts, roles, password policies and access review records that support Part 11 accountability.

GxP record archiving with a manifest of what was archived.

GxP record archiving with signed archive and restore actions and a register of archived records. Retention periods are set by your procedures.

Role-based access that matches how a regulated plant works.

Role-based access control for regulated manufacturing: roles built from permissions, kiosk scoping and segregation of duties you configure.

Minor ingredient and sub-mix weighing, from recipe room to mixer.

Minor ingredient weighing software for recipe rooms: pick lists, multi-order weighing, labelled sub-mix bags and barcode checks at the mixer.

CMMS that shows which batches an asset touched.

CMMS software for regulated plants: asset registers, work orders, spare parts, calibration links and maintenance history linked to batches.

Preventive maintenance by calendar, runtime and condition.

Preventive maintenance software with calendar, runtime and condition-based schedules, generated work orders and e-signed completion.

OEE calculated from recorded production and stops.

OEE software that calculates availability, performance and quality from recorded production data per line, shift and product.

Downtime tracking for coding and costing line stops.

Downtime tracking software that records stops with reason code, asset and duration, and links repeat causes to maintenance and CAPA.

BRCGS evidence for HACCP, prerequisites and corrective actions in one place.

BRCGS software for food and packaging sites: HACCP, prerequisite programmes, traceability tests, CCP monitoring and corrective action records.

Food safety software for UK manufacturers.

Food safety software for UK manufacturers: HACCP and CCP monitoring, allergen control, prerequisite programmes, traceability and audit records.

HACCP software for UK food manufacturers.

HACCP software for UK food manufacturers covering CCP monitoring against critical limits, verification records and corrective actions.

QMS software for UK manufacturers working to ISO 9001, ISO 13485 and GMP.

QMS software for UK manufacturers: document control, CAPA, non-conformance, internal audits, training and supplier management.

Records and controls that support MHRA GMP data integrity expectations.

Software controls supporting UK GMP data integrity: audit trails, e-signatures, batch records and deviations. Compliance remains your responsibility.

Quality records for UKCA, CE and FDA device routes.

Quality software for device manufacturers on UKCA routes: ISO 13485 records, device history records, traceability and complaints.

Production scheduling around materials, equipment and people.

Production scheduling software that plans around material status, equipment calibration and cleaning status, changeovers and operator training.

Inventory where every lot carries its quality status.

Lot-level inventory for regulated manufacturers: quarantine and release status, expiry and retest dates, FEFO picking, cycle counts and genealogy.

Device quality records for FDA QMSR, ISO 13485 and CE/UKCA routes.

Medical device QMS software for FDA QMSR (21 CFR Part 820, effective 2 Feb 2026) and ISO 13485: DHR, CAPA, complaints, supplier control and risk.

DSCSA serialisation and traceability records.

DSCSA support for serial numbers, aggregation and transaction records. Confirm EPCIS exchange and verification needs with us during scoping.

Nutraceutical manufacturing records for 21 CFR 111.

Dietary supplement manufacturing software: component identity records, master manufacturing and batch records, and label reconciliation for 21 CFR 111.

Dairy manufacturing records for pasteurisation, CIP and lot trace.

Dairy manufacturing software for pasteurisation and CCP records, CIP verification, milk intake, allergen control and lot traceability.

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