Data Integrity
Designing, assessing and improving data integrity across the full GxP lifecycle.
Data integrity sits at the heart of every GxP decision. If you cannot trust your data, you cannot trust your products, processes or reports.
We help life-sciences organisations design, assess and improve data integrity across the full data lifecycle, so you can rely on your information and stay inspection-ready. Regulators such as MHRA, FDA, EMA and PIC/S now expect ALCOA+ and data-lifecycle thinking to be visibly embedded in your quality system, computerised systems and day-to-day operations.
Why Data Integrity Matters in GxP
In pharmaceuticals, biotech and medical devices, data integrity is not optional. It underpins product quality, patient safety and regulatory trust.
Ensure inspection-ready data
Records consistently meet ALCOA+ principles and stand up to regulatory scrutiny.
Reduce compliance risk
Gaps in controls, ownership and audit trails are identified and addressed before they become findings.
Strengthen process reliability
Data flows across systems are controlled, consistent and trusted for decision-making.
Improve lifecycle governance
Data is properly managed from creation through to archival and deletion, with clear roles and controls in place.
What We Do Under Portfolio Excellence
We combine ALCOA+, CSV/CSA and data-lifecycle thinking into a coherent set of services.
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Data flows across the full lifecycle (creation, processing, storage, retrieval, archiving and deletion)
User access, roles and segregation of duties
Audit trails, logs and key system configurations
Interfaces and data transfers between systems
Use of electronic signatures and electronic records in regulated environments
Controls around system changes, upgrades and migrations
We can assess single systems or cross-cutting processes such as manufacturing, quality, maintenance or serialisation.
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Classify systems, requirements and workflows by data-integrity risk Interviewing and running workshops with subject-matter experts and front-line teams
Tailor test depth and evidence to that risk
Integrate data-integrity checks into specifications, configuration and testing
Ensure validation deliverables support data integrity throughout the system lifecycle
This helps you focus effort where it genuinely reduces risk rather than where it only increases paperwork.
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Identify critical data, critical records and critical decision points
Define controls at each lifecycle stage, including manual steps
Align procedures, system configuration and training with those controls
Embed data-integrity thinking into day-to-day operations, not only into project documents
This joins up processes, systems and people so integrity is maintained in real work, not just in validation reports.
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Prioritise issues by patient safety, product quality and data-integrity risk
Define pragmatic remediation plans that fit your operating reality
Update procedures, work instructions and governance models
Support implementation and revalidation where required
The focus is on grounded, sustainable improvement rather than one-off “paper fixes”.
Deliverables
Typical deliverables from a Process Modelling engagement include:
Scope, methods, and findings across systems or processes, with gaps mapped to regulatory expectations.
Visual models of how critical GxP data is created, processed, transferred, stored and archived across systems.
Gaps categorised by patient safety, product quality and data-integrity impact, with proposed priorities.
Definition of controls, roles (including Data Owners) and responsibilities at key lifecycle stages.
Sequenced actions spanning configuration changes, procedure updates, training and (re)validation where required.
Tailored slide decks, exercises and examples that use your systems and records.
These deliverables are designed to be reused across future projects and audits, not just for a single assessment.
Customer Stories & Insights
Outcomes You Can Expect
A clearer narrative and evidence base across GxP systems, aligned with ALCOA+ and data-lifecycle expectations.
Roles and responsibilities defined across Quality, IT and the business.
Harmonised expectations and patterns across systems and sites, reducing “weak link” risks.
Validation work that reflects real usage and data flows, not just idealised processes.
Fewer surprises during audits, upgrades and system changes, and less need for urgent remediation projects.
When to Consider Portfolio Excellence
You need a structured GxP data-integrity assessment across one or more systems
You are planning or executing a CSV / CSA project and want to build data integrity in from day one
You have received data-integrity observations from an inspection or internal audit
You are upgrading, migrating or consolidating systems and want to protect data integrity during the transition
You are introducing more automation, cloud or SaaS and need to understand how ALCOA+ applies in that context
Why Amalia
We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.
We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.
A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.
We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.
Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.
We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.
Senior leaders stay involved from start to finish on every engagement. Each programme is treated as a long-term partnership, not a one-off project.
Want to simplify complex work without losing control?
Work with a team that can join up governance, assurance, platforms and technical depth from start to finish.