Find the gap,
fix it and prove it closed

A compliance gap analysis compares what a standard requires with what your quality system defines and records, and lists where they fall short. Companies run one before certification, when adding a standard and before audits. In Qualio the analysis runs clause by clause against your own documents and evidence, and each gap comes with a recommended fix.

Map each requirement to the controls that meet it, and reuse a control wherever the standards overlap, so one procedure and its evidence answer several clauses. In Qualio one control can sit in many frameworks, and adding a standard shows which requirements your existing controls already meet.

A gap analysis checks whether your documented system meets a standard’s requirements. An internal audit checks whether people follow that system in practice. Most teams run the gap analysis first, fix what it finds, then audit. In Qualio the gap analysis runs against your procedures and evidence, so the internal audit can focus on practice.

Yes. Qualio can assess records held in MasterControl or Veeva, so a company that is not moving its QMS can still run a clause-by-clause gap analysis and track the gaps in Qualio. The documents stay where they are, in the system your team already uses.

Yes. The custom framework builder takes the text of a standard held as a Qualio document, creates its requirements, maps the controls you already have and adds new ones where needed. Teams use it for internal standards, customer requirements and document sets such as the eCTD.