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FDA and EU Good Documentation Practices (GDocP) Compliance Consulting

Each year, hundreds of medical device manufacturers run afoul of FDA, EU, and international regulations related to their documentation procedures and document control practices. While GDocP requirements are not difficult to understand, they do require clearly written procedures and ongoing diligence. If you need assistance getting your documentation practices in shape, we can help.



Good Documentation Practice Goes Well Beyond Signatures and Record Keeping

It’s the mission of FDA, European, and other national regulatory bodies to protect patients and promote medical device safety. Since inspectors and auditors (thankfully) cannot be onsite all the time, they rely on reviewing the paper trail that manufacturers leave behind, including procedures and records related to document approval, distribution, and changes.

Too often we see manufacturers that have solid document control procedures but employees who don’t follow them, or manufacturers with scant procedures that are followed but are not compliant with FDA Good Documentation Practice, ICH Q7 (Section 6), ISPE GAMP Guide, or other international requirements. Both scenarios usually do not end well when an auditor shows up.

Need Help Getting Your GDocP House in Order? Let Us Conduct an Assessment

Compliance with good documentation practice is a vital part of compliance with ISO 13485, ISO 27001, and ISO 17025. FDA mandates that all documentation must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Read more about ALCOA+ principles here. Our consulting team can assist in reviewing your documentation procedures and records for compliance with FDA GDocP and EU documentation requirements. Our review typically includes:

Quality sysyem records

  • Employee training on documentation practices
  • Employee qualification
  • Timeliness of communicating document changes to employees
  • Internal audits
  • Management reviews
  • Frequency of GDocP compliance investigations
  • Time delay between record entry and activity being recorded
  • How your records are signed and dated

Design history file (DHF)

  • Clear articulation of design and usability requirements
  • Traceability of requirements to inputs and outputs
  • Design inputs, including those from risk management
  • Design outputs, including those deemed essential or critical
  • Design verification and validation

Device master record (DMR)

  • Device specifications
  • Production and process specifications
  • Quality assurance and specifications
  • Packaging / labeling specifications and customer feedback
  • Product installation, maintenance, and servicing

Device history record (DHR)

  • Manufacturing dates and quantities
  • Product acceptance
  • Labeling used for each production, batch, or lot
  • Documents showing who examined label for release

We can customize our assessment based on your specific needs, focusing on specific areas or facilities as desired.

We’re Ready to Help

Clear documentation procedures and complete records are signs of a well-functioning QMS, and auditors know this. Once an auditor finds systemic problems with documentation, alarm bells go off and they tend to dig deeper into other areas. Let our team help get your documentation procedures back on track before your next inspection or audit.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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