Start from the sponsor's rules
Take the approved uses, prohibited uses, and approved tools from the sponsor's AI policy and SOPs. Where that policy does not exist yet, the gap is recorded and AI policy and procedure work comes first.
Regulated Industry Infrastructure
Real Work.
Accountable Outcomes.
Every Contribution Tracked.
Picture work where every outcome has an owner, the evidence builds as the work happens, and everyone who contributed is credited. These are real engagements where Aregis is doing that now, from AI readiness to regulated quality work.
GAME Plan, Aregis's planning and delivery system, is available now and holds that trail for the engagement. Saga Agent, an AI agent that completes clearly bounded tasks under human review, is in active testing. Where it is used, its actions and sources join the same trail, but it is not required for the work to proceed.
In active engagement
Workforce Training on AI Use
People are already using AI at work, often without a clear rule for what is allowed. Aregis trains a sponsor's staff by role to use approved AI tools under the sponsor's policy and SOPs, and records the training so it can stand up to an audit.
Set the training by role
Decide what each role may use AI for, which tools and data it may use, and which decisions stay with a qualified person. An author, a reviewer, and an approver do not need the same training.
Teach review, recording, and escalation
Show people how to check AI-assisted output against the source, how to record that AI was used, and when to stop and escalate. Nothing AI-assisted is treated as a decision until the responsible person accepts it.
Record completion and understanding
Record who was trained, on which version of the policy, and how understanding was checked. Retrain when the policy, the approved tools, or the role changes.
What the training record keeps
Role
Approved AI uses
Data limits
Policy version
Completion and check
The training leaves a trail from each role, through the approved uses and data limits it was trained on, to the completion record against a specific policy version. Aregis keeps that trail on GAME Plan, which is available now. The sponsor's qualified people remain responsible for the policy and for accepting AI-assisted work. Saga Agent is in active testing and is not required for this engagement.
In active engagement
AI-Assisted Training System Deployment
Training has to stay current as SOPs change, remediation lands, and new procedures roll out. Aregis helps teams design and introduce procedure-linked training that may use client-approved AI tools to draft and update material, while qualified people approve what is trained and the training records stay complete.
Link training to the procedures
Map each SOP and work instruction to the roles that must be trained on it, so a procedure change points directly to the training that has to change with it.
Draft and update the material
Client-approved AI tools may draft or update training material from the controlled procedure. Every draft points to the SOP version it came from, so a reviewer can check it against the source.
Review and approve under change control
A qualified owner reviews and approves the material before it is released. Training changes follow the same change control as the procedure, and nothing is trained from an unreviewed draft.
Roll out and record
Assign the training by role, record completion and any check of understanding, and keep those records aligned with the LMS or training system the organization already uses.
What the training record keeps
SOP and version
Role
Training material
Approver
Completion record
The training leaves a trail from each procedure version, through the material drafted from it and the person who approved it, to the completion record for each role. Aregis keeps that trail on GAME Plan, which is available now. Qualified training owners remain responsible for what is trained. Saga Agent is in active testing and is not required for this engagement.
In active engagement
AI Opportunity Analysis for Sponsors
Before a sponsor writes an AI policy, trains people, or puts a tool into a regulated process, the useful question is where AI would actually help and where it should stay out. Aregis reviews the sponsor's work and turns that review into an opportunity matrix the team can use to choose the next engagement.
Name the sponsor's work
Identify the processes that carry quality, regulatory, or program risk. That may include complaints, CAPA, SOP control, submissions, training, supplier oversight, and the decisions a qualified person must still accept.
Separate useful AI from work that stays human
For each process, record where AI could prepare, compare, or draft, and where the SOP, the data, or the decision requires a person. An opportunity is not permission to treat model output as the decision.
Record the constraints
For each opportunity, note the data that may be used, the data that must stay out, the review the procedure already requires, and the SOP or training that would have to change before the work could use AI.
Build the opportunity matrix
The matrix records the work area, the AI opportunity, the constraint, the owner, and the recommended next step. That next step may be an AI policy and procedure, workforce training on AI use under that policy, or a bounded workflow. The sponsor decides which items to pursue.
What the opportunity matrix shows
Work area
AI opportunity
Constraint
Owner
Next step
The matrix stays on a trail: each work area, the opportunity considered, the constraint, the owner, and the decision to pursue it or leave it. Aregis keeps that trail on GAME Plan, which is available now. Qualified people at the sponsor remain responsible for which opportunities to pursue. Saga Agent is in active testing and is not required for this engagement.
In active engagement
AI Policy and Procedure in the QMS
Once a sponsor knows where AI will be used, the quality system has to say how. Aregis helps write the AI policy and the procedures under it so approved uses, human review, change control, and records are part of the QMS rather than informal practice.
Define approved and prohibited uses
Start from the opportunity analysis, or from current practice, and state which uses of AI are approved, which are prohibited, and which tools are authorized for each.
Assign human review
For each approved use, name the role that reviews the output, what they check it against, and the point at which a qualified person accepts or rejects it.
Connect the change to the SOPs
Identify the SOPs, forms, and training that change when AI enters a process, and move those changes through the organization's normal change control.
Set the records
Decide what record shows that AI was used, which sources it used, who reviewed the result, and what was decided, so the practice can be shown to an auditor.
What the procedure set covers
Approved use
Authorized tool
Required review
Affected SOP
Record kept
The policy leaves a trail from each approved use, through the review it requires and the SOPs it changed, to the record that shows the practice was followed. Aregis keeps that trail on GAME Plan, which is available now. The sponsor's quality leadership remains responsible for approving the policy and procedures. Saga Agent is in active testing and is not required for this engagement.
In active engagement
Procedure-to-Standard Gap Matrix
When a process has to meet a standard, the useful question is which procedures cover which requirements, and where the practice falls short. Aregis maps the SOPs to the applicable standard and turns the differences into a gap matrix the team can use to improve compliance.
Name the process and the standard
Identify the process, the SOPs and work instructions that govern it, and the standard or regulation the organization has to meet. That may include ISO 13485, 21 CFR, EU MDR or IVDR, or the organization's own quality requirements.
Map each requirement to the current procedure
Place each applicable requirement next to the SOP section, record, or practice that is supposed to satisfy it. Where nothing covers the requirement, the map shows that directly.
Build the gap matrix
The matrix records the requirement, the current SOP or practice, the gap, who owns it, and the improvement that would close it. A gap may be a missing procedure, a procedure that does not match the work, or a record the process does not produce.
Use the matrix to improve the process
Prioritize the gaps, assign the procedure or practice changes, and keep the evidence of closure with the work. The matrix is the plan for process compliance improvement, not a one-time report.
What the gap matrix shows
Standard requirement
Current SOP or practice
Gap
Owner
Improvement
The gap matrix stays on a trail: each requirement, the SOP it was mapped to, the gap, the owner, and the evidence that an improvement closed it. Aregis keeps that trail on GAME Plan, which is available now. Qualified people remain responsible for the compliance conclusions.
In active engagement
Complaint Investigation Writing
A complaint investigation has to be written from the source records, follow the complaint SOP, and leave a qualified person responsible for the conclusion. Aregis helps teams write that record with sanitized sources, explicit references, a look at whether the complaint is part of a trend, and the human review the procedure already requires.
Sanitize the sources
Prepare the records that may enter the investigation file. Remove or withhold personal data, uncontrolled identifiers, and material the complaint SOP does not allow in the narrative. Keep a controlled link to the original record so the sanitized source can still be checked.
Reference every material statement
Each finding, date, lot, complaint detail, and quoted observation in the write-up points to the source it came from. A reviewer can see what was used and what was left out.
Place the complaint in the trend
Compare the complaint with related complaints over the period the SOP defines. Record the product, lot, failure mode, and count so the write-up shows whether this event stands alone or continues a trend. A rising trend is called out for the review the procedure requires, and it stays in the investigation record rather than in a separate list the narrative never mentions.
Write inside the SOP
The narrative follows the complaint procedure: scope, facts, investigation steps, possible causes, conclusion, and any required follow-up. The SOP defines what a complete investigation record contains.
Human review before the record is accepted
Drafting may use client-approved tools. A named person reviews the sanitized sources, the references, and the conclusion, then accepts or returns the write-up. That human-in-the-loop step is the SOP's approval. Tool output is not the investigation decision.
What the investigation file keeps
Sanitized source
Source reference
Trend context
Reviewer
SOP decision
The investigation leaves a trail from each sanitized source, through the references and the trend check, to the person who accepted the record. Aregis keeps that trail on GAME Plan, which is available now. Qualified complaint owners remain responsible for the conclusion. Saga Agent is in active testing and is not required for this engagement.
In active engagement
CAPA Investigation Writing
A CAPA investigation has to be written from the source records, follow the CAPA SOP, and leave a qualified person responsible for the root cause, the actions, and the conclusion. Aregis helps teams write that record with sanitized sources, explicit references, a look at whether related CAPAs form a trend, and the human review the procedure already requires.
Sanitize the sources
Prepare the records that may enter the CAPA file. Remove or withhold personal data, uncontrolled identifiers, and material the CAPA SOP does not allow in the narrative. Keep a controlled link to the original record so the sanitized source can still be checked.
Reference every material statement
Each finding, date, lot, deviation detail, and quoted observation in the write-up points to the source it came from. A reviewer can see what was used to support the root cause and what was left out.
Place the CAPA in the trend
Compare the CAPA with related CAPAs over the period the SOP defines. Record the process, product, failure mode, and count so the write-up shows whether this action stands alone or continues a trend. A repeated cause is called out for the review the procedure requires, and it stays in the CAPA record rather than in a separate list the narrative never mentions.
Write inside the SOP
The narrative follows the CAPA procedure: problem statement, investigation, root cause, corrective and preventive actions, and the plan for checking effectiveness. The SOP defines what a complete CAPA record contains.
Human review before the record is accepted
Drafting may use client-approved tools. A named person reviews the sanitized sources, the references, the trend, and the proposed actions, then accepts or returns the write-up. That human-in-the-loop step is the SOP's approval. Tool output is not the root-cause decision.
What the CAPA file keeps
Sanitized source
Source reference
Trend context
Reviewer
SOP decision
The CAPA leaves a trail from each sanitized source, through the references and the trend check, to the person who accepted the root cause and the actions. Aregis keeps that trail on GAME Plan, which is available now. Qualified CAPA owners remain responsible for the root cause and the actions. Saga Agent is in active testing and is not required for this engagement.
Other Ways Aregis Can Help
AI Opportunity Analysis for Sponsors
Review where AI would help a sponsor's quality, regulatory, and program work, and where it should stay out. The trail runs from each work area through the constraint to the decision to pursue a policy, training, or a bounded workflow.
AI Policy and Procedure in the QMS
Write the AI policy and procedures so approved uses, human review, change control, and records are part of the quality system. The trail runs from each approved use to the record that shows it was followed.
Workforce Training on AI Use
Train staff by role on approved AI uses, data limits, review, recording, and escalation. The trail runs from each role to a completion record against a specific policy version.
Portfolio Priorities and Delivery
Bring projects, resources, risks, decisions, and deadlines into one view. Aregis can help leadership choose priorities, establish ownership, manage dependencies, and keep delivery connected to business goals.
Program and Project Recovery
When important work is late, unclear, or spread across teams, Aregis can establish a practical plan, clarify decisions and responsibilities, surface blockers, and restore a reliable path to completion.
Procedure-to-Standard Gap Matrix
Map the procedures that run a process to the standard they must meet, then use a gap matrix to prioritize improvements. The trail runs from each requirement to the change that closed the gap.
Quality and Regulatory Operations
Support quality systems, audit readiness, regulatory change, submissions, and operational compliance across pharmaceuticals, medical devices, and other regulated manufacturing environments.
Complaint Investigation Writing
Write the investigation from sanitized sources, with a reference for each material statement, a trend check against related complaints, and a human review that follows the complaint SOP. The trail runs from the source to the accepted record.
CAPA Investigation Writing
Write the CAPA from sanitized sources, with a reference for each material statement, a trend check against related CAPAs, and a human review that follows the CAPA SOP. The trail runs from the source to the accepted root cause and actions.
AI-Assisted Training System Deployment
Link training to the procedures, draft and update material with client-approved AI tools, approve it under change control, and record completion by role. The trail runs from each SOP version to the completion record.
CAPA and Complaint Investigations
Organize records, interviews, possible causes, corrective actions, deadlines, and effectiveness checks so qualified people can reach and support clear investigation conclusions.
Technical and Controlled Documents
Coordinate source material, subject-matter input, requirements, authors, reviewers, revisions, and approvals for technical writing, procedures, reports, and controlled documents.
Contracts, Suppliers, and Partners
Connect contract terms, quality agreements, supplier commitments, deliverables, changes, performance records, and escalation paths so external relationships remain accountable.
Clinical, Nonclinical, and Manufacturing Programs
Maintain a shared view of milestones, partner obligations, issues, changes, decisions, and evidence across clinical operations, nonclinical work, CMC, manufacturing, and quality.
AI and Digital Workflows
Turn a manual or fragmented process into a clear workflow with defined inputs, owners, controls, records, and human review. Aregis can run that workflow on GAME Plan, which is available now. Additional AI capabilities are in active testing on real projects.
Flexible Expert Teams
Add experienced professionals or specialized firms when the organization needs focused expertise or delivery capacity. The HC Accelerator can support a single assignment or a broader managed engagement.