If a company is trying to determine whether they meet a specified standard, guideline, regulation, or other requirement, gap analysis can be a useful tool for that assessment.  A gap analysis will compare a company’s current processes to the standard, guideline, or regulation they are trying to meet.  The output will be a set of recommendations on updates that are needed to align the process with the requirement.

In the life sciences industry, gap analyses are frequently done against regulatory requirements, guidelines, and national and international standards.  There are a few common scenarios where a gap analysis is performed:

  • When a regulatory requirement or a standard is updated, and a company wants to identify changes needed to meet the new requirements
  • When a company wants to meet a regulatory requirement or standard for the first time
  • When a company needs to respond to an audit or inspection finding, and needs a comprehensive plan for making updates

 

Globiox consultants have experience performing various types of gap analyses.  Some recent examples include:

  • ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) E6 R2: Guideline for Good Clinical Practice
  • FDA regulations for clinical trials including:
    • 21 CFR Part 50: Protection of Human Subjects
    • 21 CFR Part 54: Financial Disclosure by Clinical Investigators
    • 21 CFR Part 56: Institutional Review Boards
  • 21 CFR Part 820: FDA Quality Systems Regulations for medical devices
  • 21 CFR Parts 211 and 212 FDA regulations for Current Good Manufacturing Practices
  • 21 CFR Part 11: FDA regulations for electronic records
  • ISO (International Organization for Standardization) 13485: Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes
    • Upgrading from 2003 to 2016
    • Implementing 2016 from scratch
  • Technical files/design dossier assessments against:
    • Essential requirements for medical devices as outlined in the European Medical Device Directive (MDD/AIMDD/IVDMDD)
    • General Performance and Safety requirements as outlined in the European Medical Device Regulation (MDR/IVDR)
  • Transitioning from European MDD/AIMDD/IVDMDD to MDR/IVDR
  • Assessment of updates to ISO, ASTM, ANSI, and other recognized standards

Regardless of the requirement your company is trying to meet, Globiox has the expertise to perform a thorough and comprehensive gap analysis.  However, Globiox’s expertise does not end with providing a report with recommended updates.  We are also able to support making those updates, whether they be to quality systems documents, procedures, records, data, validations, reports, or anything else.