Our Data Integrity Service Portfolio
Many consultants deliver slides. We deliver a robust GAP assessment: from the public quick check through the full questionnaire to technical implementation and lifecycle support – for pharma operators and instrument manufacturers alike.
Entry point
Data Integrity Check
The public quick check identifies initial action areas in eight questions covering audit trails, access rights, raw data and laboratory instruments – no registration required, as orientation before the deeper assessment.
Outcome: maturity assessment and prioritised first actions
- ALCOA+-oriented questions on system and process
- Instant evaluation in the browser
- Direct path to the full GAP assessment
Core service
DI GAP Assessment with 10-Year Questionnaire
Together with your team – and for manufacturers with product management and support – we work through the full questionnaire we have refined over ten years in projects, audits and supplier evaluations. Remote via workshop or on-site in the laboratory, in production or at the manufacturer.
Outcome: risk-based GAP assessment with location, ALCOA+ reference and priority per finding
- System inventory with criticality assessment
- Interviews, configuration review and process observation
- Gap list per ALCOA+/ALCOA++ principle with evidence
Analysis
Gap Analysis & Risk Assessment
We assess electronic and paper-based processes against 21 CFR Part 11, EU GMP Annex 11 and PIC/S PI 041. Data integrity is rarely software alone – we review configuration, privileges, SOPs and the way people actually work.
Outcome: prioritised action plan with effort, owner and target date
- Technical, procedural and organisational gaps separated
- Risk assessment per system and process step
- Alignment with QA and subject matter experts
Implementation
Remediation & Technical Solutions
Our experienced IT specialists implement what has a measurable effect: audit trail configuration, role and privilege concepts, blocks against local intermediate storage, hardened system settings and controlled data handovers – in a validated environment.
Outcome: implemented measures with configuration evidence and test protocol
- Part 11/Annex 11-compliant system hardening
- Secure interfaces and archiving
- Linked to CSV and qualification
Documentation
SOPs & Validation Documents
We produce SOPs, validation documents and test cases that anchor requirements for the long term – worded verifiably so that statement and practice match in an audit.
Outcome: release-ready SOP drafts and test evidence
- Role-based work instructions
- Audit trail review procedures
- Change control documentation
People
Training & Awareness
Laboratory, production, IT and QA receive role-based training: ALCOA+ principles, typical everyday mistakes and escalation routes for anomalies – remote or on-site.
Outcome: training material with participant evidence
- Practical examples from your system context
- Manufacturer training for DI-ready product concepts
- Refresher sessions before inspections
Operations
Lifecycle & Inspection Readiness
After the assessment, work continues: change control, periodic review, recurring audit trail reviews and preparation for FDA/EMA inspections – so the DI status does not erode.
Outcome: sustainable DI status with documented reviews
- Periodic review and re-assessment
- Mock audit and finding preparation
- Optional: external Validation Manager
What sets us apart: The questionnaire is not a download product but a living tool – sharpened in every project. You work with IT experts who assess regulated systems and also configure and validate them.
Plan your GAP assessment – remote or on-site?
Request initial consultationDI guide
Who needs Data Integrity support?
Choose your role or starting point. You receive the right entry route – including references and contact path.
GxP operator: assess systems and processes
GAP assessment for LIMS, CDS, MES, laboratory IT and paper-near processes – with an action plan that holds up in an audit.
Instrument manufacturer: become DI-ready
We support manufacturers with audit trail, user and interface concepts – so your customers can qualify without rework.
Buying a system: DI before investment
DI assessment before procurement – so gaps do not become expensive only during the CSV project.
Close findings
Structured remediation after a warning letter, Form 483 or internal audit – prioritised and traceable.
International: remote or on-site
We work across Germany, DACH and internationally – remote workshops and on-site visits wherever your sites and manufacturers are.
Data integrity from a single source means one questionnaire, one team, one action plan – from the first gap to inspection readiness. No consultant handover between analysis, IT implementation and validation.
Reference: DI gap assessment on a validated GxP software landscape. Read the case story
Remote, on-site, international
You decide how we collaborate – the questionnaire and methodology remain equally robust.
Workshop & screen share
Questionnaire walkthrough, configuration review and interviews via video conference – efficient for distributed teams and initial gap reviews.
In the lab & at manufacturers
On-site visits in production, QC or at the instrument manufacturer: process observation, system demos and alignment with QA on location.
Across borders
Projects in DACH and internationally – in English and German, with experienced IT consultants who know regulated environments.
Six service areas – one DI programme
Data integrity touches QA, IT, validation and supplier management. That is why we involve all six cube one GmbH areas – without media breaks.
Data Integrity consulting
DI GAP assessment, questionnaire, remediation – the core of this page.
View services above ›Equipment and facility qualification
DI-ready equipment qualification and instrument integration.
View equipment qualification ›Software validation (CSV)
System validation after GAP assessment and action plan.
View CSV ›IT administration
Technical implementation: audit trail, roles, hardening, archive.
View IT administration ›Project management
Schedules, suppliers and milestones in the DI programme.
View project management ›Software development
Interfaces, tools and automation for DI-compliant data flows.
View software development ›Data Integrity Check & GAP Assessment
Start with our public Data Integrity Check: eight questions identify initial action areas. For a robust evaluation, we work through the full questionnaire developed over ten years with you – remote or on-site.
Start the Data Integrity CheckWhat Is Data Integrity and Why Is It Critical?
Data integrity is an inspection topic in its own right. The FDA and EU authorities examine whether data is attributable, recorded contemporaneously, traceable when changed and available over the retention period. Findings regularly lead to warning letters and measures up to the suspension of releases.
The scope runs from electronic and paper-based capture through processing to archiving. We map cyber and IT security requirements in the Regulatory Expertise Center.
Data integrity is rarely a software problem alone. Gaps sit between system configuration, privileges, SOP and the way people actually work. Our questionnaire covers all four levels – which is why it works for operators and manufacturers alike.
ALCOA, ALCOA+ and ALCOA++ in Detail
The FDA guidance describes ALCOA; MHRA, WHO and PIC/S use ALCOA+. We explain all ten attributes under ALCOA, ALCOA+ and ALCOA++.
For Laboratory Instrument Manufacturers
We support manufacturers and suppliers with DI-ready system design, audit trail and user concepts, technical documentation and secure interfaces – for supplier audits and GxP qualification at the customer. We work through the same questionnaire together: your product becomes auditable, your customers qualify faster.
After the assessment: stay compliant
A GAP assessment is the start – not the goal. Two pillars keep data integrity alive in operations.
Lifecycle management
- Change control for system and process changes
- Periodic review and re-assessment
- Recurring audit trail reviews
Inspection readiness
- Mock audit and finding preparation
- Evidence chain for FDA and EU inspectors
- Remediation after Form 483 or warning letter
Regulatory framework: Part 11, Annex 11, PIC/S and GAMP 5
Data integrity programmes rely on the rules that define requirements for records, systems and processes:
- 21 CFR Part 11: electronic records and signatures for US markets and global harmonisation.
- EU GMP Annex 11: lifecycle of computerised systems, audit trail, access control and change control.
- PIC/S PI 041: good practices for data management and integrity in regulated GMP/GDP environments.
- ISPE GAMP 5, 2nd Edition: risk-based approach for CSV and software categories – complemented by Computer Software Assurance (CSA).
- ALCOA, ALCOA+ and ALCOA++: attribute model for attributable, legible and traceable GxP data.
