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DATA INTEGRITY / PROCESS TO CONTROLS
Data Integrity Assessment & Remediation
Identify data integrity gaps, understand their risk, and establish the actions needed to address them.
SOLVE performs GMP data integrity assessments for manufacturing processes, utility equipment, and laboratory workflows. We map how data is generated and handled, evaluate technical, procedural, and behavioral controls, and classify identified risks. The assessment delivers documented findings, risk ratings, and prioritized recommendations for improvement.
Control Assessment
Process Mapping · Risks Assessment · FMEA
Process and Data Mapping
Risks located at the steps where they arise
Control Gap Assessment
Technical, procedural and behavioral
Prioritized Action Plan
Risk acceptance, actions and review needs
01 ASSESSMENT SCOPE
What can we assess?
A GMP data integrity assessment follows the data through the selected process, from its source and recording to review, transfer, storage, and retrieval.
01/ ASSESSMENT AREA
Process and data flow
Process steps, data sources, inputs, outputs, owners, and handoffs between paper records and electronic systems.
03/ ASSESSMENT AREA
Procedural control
Training, demonstrated understanding, actual recording practices, and whether personnel follow the controls during routine work
05/ ASSESSMENT AREA
Risk and acceptance
Severity, probability, detectability, RPN, risk classification, acceptance rationale, and the actions required for each identified risk
02/ ASSESSMENT AREA
Technical controls
Individual accounts, access permissions, system settings, audit trails, data transfer checks, and backup or retrieval controls.
04/ ASSESSMENT AREA
Behavioral controls
Training, demonstrated understanding, actual recording practices, and whether personnel follow the controls during routine work
AGREED IN YOUR PROTOCOL
Focused gap assessment
Need a focused data integrity gap assessment? Share the process or equipment you want reviewed, existing concerns, and available procedures.
ALCOA+ principles applied to each process
An ALCOA+ data integrity assessment evaluates whether records are attributable, legible, contemporaneous, original, and accurate, as well as complete, consistent, enduring, and available.
We connect these principles to the actual process steps and controls. Your assessment shows where a weakness occurs, which data it affects, and how the risk should be addressed.
02 STUDY THE DATA INTEGRITY
Why map the process before scoring risk?
A missing entry or shared account is part of a wider workflow. Process mapping shows where data originates, how it changes hands, and which controls protect the decisions made from it.
Locate risks at the process steps where they arise
Distinguish controls that exist on paper from controls used in practice
Give QA and process owners a documented basis for action and acceptance
When to assess or revisit data integrity assessment
Start with a baseline assessment for an unassessed process. Keep the assessment current through defined review intervals and event-based review under your quality procedures.
New equipment and validation
Assess data flows and controls when introducing equipment or systems, or as part of relevant qualification and validation activities.
Changes to the process or its controls
Review the assessment when software, interfaces, data flows, permissions, procedures, responsibilities, or retention arrangements change.
CAPA and quality events
Revisit affected risks after discrepancies, deviations, audit findings, or CAPA. Periodic review should also consider whether existing controls remain effective.
Prepare for the assessment
Bring the people and evidence needed to understand both the documented process and routine practice.
Process and system owners, with agreed assessment boundaries
Available process maps, procedures and representative records
Controlled access to relevant settings and working practices
Your approved scoring matrix and risk acceptance criteria
Existing findings, changes, deviations or CAPA relevant to the scope
How SOLVE performs the work?
03 MAP, ASSESS & FOLLOW THROUGH
01
Define and map the process
Agree on scope, boundaries, records, and stakeholders. Map process steps, data sources, inputs, outputs, transfers, and ownership with your team.
02
Identify risks and existing controls
Assign risks to the relevant steps. Review technical, procedural, and behavioral controls against procedures, demonstrations, observations, and selected records.
03
Calculate and classify current risk
Perform a data integrity risk assessment using your approved scoring matrix. Document severity, probability, detectability, RPN, classification, and rating rationale for each risk.
04
Determine acceptance and actions
Document the acceptance decision. Define risk reduction or CAPA recommendations for unacceptable risks, including interim controls where needed, proposed owners, and closure evidence.
05
Document residual risk and review needs
Estimate risk after the proposed controls and define follow-up checks. Confirm achieved risk reduction through implementation evidence and effectiveness review within the agreed scope.
Map & Assess
Link risks to process steps and evidence. Document control coverage, scoring rationale and recommended actions.
Approve Decisions
Approve risk acceptance, CAPA and closure through your site’s quality procedures.
Verify Improvements
Assess implementation evidence and effectiveness within the agreed scope before confirming achieved risk reduction.
A proposed lower RPN is not closure. Anticipated residual risk must be distinguished from achieved risk reduction supported by implementation evidence, effectiveness review and site approval.
04 A DOCUMENTED BASIS FOR ACTION
What you recieve?
Your team receives a documented risk classification, an acceptance rationale, and specific recommendations for risk reduction or CAPA where needed.
A process and data map showing the assessed steps, records, transfers, and owners
A risk and control register linking each risk to technical, procedural, and behavioral controls
An RPN assessment with scoring rationale, risk classifications, and acceptance decisions
An action plan with recommendations, proposed responsibilities, interim measures where needed, and anticipated residual risk
An assessment report and review documenting conclusions, limitations, and future review needs
The assessment reflects the agreed scope and available evidence. Your process owner and quality team approve risk acceptance, CAPA, and closure decisions.
FROM PROCESS STEP TO FOLLOW-UP
How your findings can be organized
Traceable assessment
Connect each risk to a process step, affected data, existing controls and supporting evidence.
Visible action status
Separate recommendations, anticipated residual risk and verified closure.
This outline contains no actual findings, scores, risk classifications or acceptance decisions. Your approved matrix, available evidence and agreed scope govern the assessment.
YOUR APPLICATION
Assessment for your operation
Manufacturing and utility equipment
A manufacturing data integrity assessment can cover weighing, preparation, process readings, equipment logs, transfers, and cleaning records. Utility assessments follow operating, monitoring, and maintenance data through the relevant equipment process.
Laboratory workflows
A laboratory data integrity assessment maps sample identification, instrument output, calculations, result reporting, and review, including links between original data and reported results.
Remediation and inspection support
Our data integrity remediation services can support procedure revisions, control improvements, and effectiveness checks. Data integrity audit services and data integrity inspection readiness support can focus on assessment evidence, unresolved risks, and action status. Implementation and follow-up are defined in your quotation.
Data integrity support in California
SOLVE provides pharmaceutical data integrity consulting in California, including GMP data integrity assessment support in the San Francisco Bay Area. Work with a data integrity consultant in California to define the onsite and remote activities your process requires.
05 SCOPE-BASED PRICING
What does a data integrity assessment cost?
Cost depends on process complexity, equipment and systems, data interfaces, available documentation, site access, and follow-up requirements. Your quote defines the assessment boundaries, review coverage, deliverables, and remediation support included.
