QikSolve insights
Perspectives on regulation, quality systems, Microsoft 365, and the evidence that helps teams make workable decisions.
Featured insight
Compliance
A calibration register that only tracks equipment IDs, dates, and certificate references is a different risk to a spreadsheet that calculates pass or fail. A practical, risk-based look at what validation it may actually need.
Keep exploring
Compliance
Excel looks like the cheapest option for GMP registers until you count the effort needed to demonstrate control, accuracy, and data integrity. A risk-based way to decide what a spreadsheet actually needs.
Compliance
Once a spreadsheet calculates pass or fail, status, or trend, it is no longer just a register. A practical look at what validation, evidence, and audit questions change once formulas start deciding GMP outcomes.
Compliance
Most organisations assume SharePoint requires more validation effort than Excel. In practice, many of the controls a spreadsheet needs built around it already exist natively in a governed SharePoint list.
Compliance
Many regulated organisations still rely on Excel for training, supplier, equipment and quality registers. Learn why spreadsheets become audit findings and how governed digital registers can reduce compliance risk.
AI Governance
The assumption that better prompts yield better outputs breaks down entirely when you move from single-shot generation to agent-based systems. The real lever is architecture.
AI Governance
The production team wants to deploy an AI agent that reviews batch manufacturing records within a month. What questions should QA ask before approving it for GxP use?
AI Governance
Six months after deployment, a deviation trend-analysis agent is now cited as evidence in CAPA closures. Is that still appropriate use, and what changed without anyone noticing?
AI Governance
An AI assistant that answers procedural questions quickly became popular across the site. Rapid adoption is not the same thing as compliance fitness.
AI Governance
The system did not change and no change control was raised, but the way people actually used it drifted from a structured review workflow to a single question.
AI Governance
A strong audit defence for AI-assisted batch record review does not require explaining the technology — only clear governance, defined scope, and human oversight.
AI Governance
How a PIC/S GMP-regulated cannabis manufacturer moved from uncontrolled consumer AI tools to a governed, auditable model built on Microsoft 365 Copilot.
Compliance
A practical guide to the questions GMP teams should ask about computerised systems, from risk and responsibilities to data integrity, change control, and recovery.
Compliance
How GMP teams can use SharePoint Lists to improve quality-register visibility while preserving the authoritative record and applying proportionate controls.
Compliance
Most organisations frame documentation modernisation as a software-spend decision. In practice it is a cost-of-inaction decision, and the hidden cost is recurring, not one-off.
Compliance
A practical reading of what the draft Annex 11 may mean for GMP teams considering generative AI, M365 Copilot, and AI-assisted documentation.
Compliance
A practical language for distinguishing predictive, generative, and agentic AI, and matching testing and oversight to the role AI plays in regulated work.
AI Governance
Human bias and LLM bias differ in mechanism but combine in GxP workflows while decisions still appear reasonable. Governance has to rely on evidence, not intent.
Quality Systems
How the BIM Levels of Development framework, applied by partners like PharmOut, gives regulated facility projects a shared language for design maturity and scope.
AI Governance
The core reframe for AI agent governance in regulated quality work — stop treating AI as software to validate, and start governing it as a worker within your QMS.
AI Governance
AI governance in pharma is not a greenfield problem. It is a quality-systems extension problem — mapping AI agent management maturity to QMS maturity that already exists.
Compliance
Computerised system validation exists to build confidence, not paperwork. A practical, risk-based approach to CSV for teams moving from paper to electronic systems.
AI Governance
A structured, compliance-aligned approach to operating AI agents as controlled digital workers in regulated environments — good practice first, regulation second.
AI Governance
What FDA, EMA, MHRA, and TGA actually expect of AI agents in GxP — appropriately scoped, risk-based, transparent, human-overseen, and fully traceable.
Productivity
Copilot Tasks lets teams delegate multi-step work to a governed digital delegate. For regulated consulting firms, the highest value clusters around reporting, monitoring, and compliance.
Compliance
A scalable, risk-based approach to validating a SharePoint quality register while the paper record remains the authoritative GMP source of truth.
Compliance
What recurring computerised-systems and data-integrity observations suggest about inspection readiness beyond the validation binder.
AI Governance
The professionals best placed to design effective AI agents in regulated industries are not software engineers — they are technical writers and compliance professionals.
GMP
How QikSolve's INQ platform configures CAPA management on SharePoint to meet CFR 21 Part 11 and Annex 11 requirements.
GMP
How QikSolve configures SharePoint electronic records, signatures, access controls, and validation to meet GMP compliance requirements.
ISO9001
How QikSolve configures SharePoint lists, pages, apps, and libraries to meet the clauses of ISO 9001.
Reporting
How QikSolve's Power BI reports and dashboards unlock insights into document authoring time, update timeliness, usage, and per-department counts.
Compliance
How QikSolve configures Microsoft Azure to meet CFR 21 Part 11 and Annex 11 requirements for pharmaceutical and life sciences organisations.