We design documentation that regulators respect and employees actually use—balancing compliance, clarity, and usability. Our approach covers three dimensions: content, process, and implementation.
Content: What We Create
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Core SOPs: Foundational quality system procedures (CAPA, complaints, audits, training, design control, etc.)
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Supporting documents: Work instructions, job aids, and forms/templates that bring SOPs to life.
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Specialized procedures: Manufacturing, lab, IT/data integrity, supplier management, equipment/facilities, and product release.
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Document hierarchy: Quality manuals, SOPs, WIs, and forms organized into a scalable structure.
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Process: How We Write & Review
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Gap analysis: Identify missing, outdated, or noncompliant procedures.
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Regulatory mapping: Ensure alignment with FDA, ISO, ICH, and global requirements.
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Plain-language writing: Procedures written for operators first, auditors second.
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Standardization: Style guides, formatting, and numbering systems that ensure consistency.
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Cross-functional reviews: Collaborative drafting process to capture real practices.
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Implementation: How We Ensure Adoption
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Training materials: Role-based curricula, quick-reference guides, and onboarding aids.
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Document control setup: Systems for approvals, versioning, distribution, and archival.
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Change management: Rollout strategies to replace old practices with new documentation smoothly.
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Annual review programs: Scheduled updates to keep documentation current and audit-ready.
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Effectiveness checks: Feedback loops and audits to confirm SOPs are followed in practice.
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Specialized Support (When Needed)
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SOP harmonization: Standardize across sites, divisions, or acquisitions.
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Paper-to-digital transition: Migrate legacy SOPs into eQMS platforms.
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Remediation projects: Rewrite or overhaul SOPs flagged in 483s, Warning Letters, or audits.
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Complex system documentation: Procedures for computerized systems, data integrity, and cybersecurity.
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