QikSolve insights
Perspectives on regulation, quality systems, Microsoft 365, and the evidence that helps teams make workable decisions.
Featured insight
Compliance
Define a computerised system's purpose, users, data and decision boundaries with a reusable intended-use template and an Excel quality register example.
Keep exploring
Compliance
Spot data integrity gaps between paper and electronic GMP records, with seven handoff checks and a pharmaceutical QC example using Excel and SharePoint.
Compliance
Compare FDA computer software assurance guidance with established validation principles, then scope a register assurance plan to its intended use and applicable requirements.
GMP
Practical questions and a fictional example for reviewing a GMP record correction without losing the original entry, its context or accountability.
Quality Systems
A practical way to review whether access to quality records still matches people’s current responsibilities—and how to document the decision.
GMP
Practical checks for reviewing GMP audit-trail evidence and documenting what the review concluded for a computerised system.
Compliance
Assess how intended use changes the risk of an equipment calibration spreadsheet and what validation may be proportionate.
Compliance
A risk-based guide to the evidence and controls for GMP Excel registers, and how to decide what each spreadsheet actually needs.
Compliance
Learn how formulas that calculate GMP outcomes change the validation, evidence, and audit questions for a quality spreadsheet.
Compliance
Compare validation considerations for Excel and SharePoint lists, including controls that may already exist in a governed environment.
Compliance
Why Excel registers can create governance challenges, and how organisations can assess when more controlled digital records may fit.
AI Governance
Why agent-system architecture matters beyond prompts, and how the shift affects the design of AI-based workflows.
AI Governance
QA questions to ask before approving an AI agent for GxP batch-record review within a proposed one-month deployment.
AI Governance
A GxP trend-analysis agent is cited in CAPA closures. Explore how changed use affects governance and oversight.
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
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AI Governance
A case study of AI governance at ECS Botanics, from consumer AI tools to a governed model using Microsoft 365 Copilot.
Compliance
A practical guide to GMP computerised systems, covering risk, responsibilities, 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
Explore the recurring costs of manual product documentation and assess modernisation as a cost-of-inaction decision.
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
How human and LLM bias can interact in GxP workflows, and why governance should rely on evidence rather than intent.
Quality Systems
How BIM Levels of Development can help regulated facility projects clarify design maturity, scope, and coordination.
AI Governance
A practical guide to governing AI agents in regulated quality work as workers within the quality system, rather than software alone.
AI Governance
Why AI governance in pharma can build on existing quality systems and practices rather than start from a greenfield model.
Compliance
A practical, risk-based guide to computerised system validation for teams moving from paper to electronic systems.
AI Governance
Explore a structured approach to operating AI agents as controlled digital workers in regulated settings, with good practice ahead of regulation.
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
See where Copilot Tasks may support regulated consulting work across reporting, monitoring, and compliance, with governance for delegated steps.
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
Explore the skills needed to design AI agents for regulated work, including technical writing, process understanding, and compliance.
GMP
How QikSolve's INQ platform configures CAPA management on SharePoint to meet CFR 21 Part 11 and Annex 11 requirements.
GMP
Assess SharePoint for pharmaceutical manufacturing: suitable uses, GMP controls, validation evidence, and when a dedicated system may fit better.
ISO9001
Explore how SharePoint can support ISO 9001 quality records, ownership, review, and improvement when it is configured around your organisation's intended use.
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.
