Regulatory gap assessment for GMP: requirements cited, gaps rated, remediation tracked and closure signed

What the module does

• Seven subject types, each with its frameworks preselected: a process, a computerized system, a procedure or document, a quality system, a facility, equipment or utility, a laboratory, and a supplier or outsourced activity.
• Up to twelve frameworks per assessment, among them 21 CFR Parts 11, 210 and 211, 600 to 680 and 820; FDA guidance on data integrity, process validation, computer software assurance, OOS results and the quality systems approach; EU GMP Parts I and II with Annexes 1, 11, 15 and 16 and the GDP guidelines; ICH Q7 to Q10, Q12, Q2 and Q14; and PIC/S PI 041 and PE 009. Other standards and corporate or client requirements are stated in words.
• The scope and intent written by the team: what to compare with what, why, and the decision the assessment informs, such as an inspection, a remediation plan, a procedure revision or a transfer. The AI keeps to it.
• Evidence of the existing state: the controlled documents already in QLogix, read at their effective version; linked validation projects, risk assessments, change controls, CAPAs and investigations; and files (PDF, Word, Excel, CSV, text and images), each fingerprinted on arrival.
• AI research clause by clause: several focused searches of the regulatory library per framework, the clauses it cites read, the evidence read, and the register drafted with an overall conclusion, the strengths, the assumptions made where the record was silent, the questions to settle before approval and the sources read with their official links.
• A complete register, not a list of problems: every requirement is a row, including the ones met, with the clause, its source by code, title, clause and page, what the existing state shows and the evidence it rests on, a rating (Compliant, Partially compliant, Gap, Not applicable or Not assessed) and the rationale.
• Findings graded Critical, Major, Minor or Observation, each with its remediation, an owner and a due date. A re-rating always needs a reason, and the overall conclusion moves with it.
• Remediation tracked to its evidence: owners emailed their finding, statuses from Open to Done with evidence and Verified effective, evidence files such as the revised procedure or the change control closure linked to the finding, and minor gaps or observations accepted only with a justification.
• Assessment approval as a signed milestone, then a signed closure that locks the record, and the gap assessment report exported as a locked PDF.

How it fits the platform

A gap assessment reads the organization's own controlled documents from document control at their effective version and links the validation projects, risk assessments, change controls, CAPAs and investigations that bear on the subject. The remediation of a finding is often done in another module, and its evidence comes back to the finding: the revised procedure, the change control closure, a test report or a training record.

Q Intelligence lists and reads gap assessments, with their conclusion, findings by severity and open and overdue remediations, and can open one from a conversation with the form prefilled for a person to review and create. Q Agent proposes opening or running an assessment as an action that waits for approval. The document hub indexes every gap assessment with its stage, and the audit trail export covers gap assessments under their own area.

Where people decide

The AI researches the frameworks and drafts the register: the requirements, the ratings, the severities and the remediation, each row citing its source. The team settles every row, re-rates with a reason, provides the evidence for anything not assessed, names the owners and due dates and decides which minor gaps and observations are accepted with a justification. The owners record the remediation and its evidence, and the approvers sign the assessment approval and the closure.