Define the development scope
Establish intended use, product requirements, current stage, technical gaps, available evidence, and required expertise. Agree on deliverables and decisions requiring sponsor or specialist review.
Regulated Industry Infrastructure
Defined Scope.
Documented Results.
Qualified Review.
Explore assignments across product development, quality systems, documentation, and training. Bring another workflow or program to scope with the network. Each engagement defines inputs, responsibilities, deliverables, qualified review, and measures of success.
GAME Plan connects responsibilities, sources, decisions, contributions, and acceptance in a shared engagement record. The same delivery method can be applied across assignments and teams. Qualified personnel retain technical acceptance and regulated decisions. Saga Agent and Convergence are actively testing; their use requires agreed scope and applicable controls.
Shared specifications under development address consistent source references, review dispositions, and handoffs across participants. Sponsor-system integration is assessed and scoped separately.
Shared Specifications for Coordinated Work →Product Development and Transfer Readiness
Coordinate development activities across sponsor teams and specialist partners, from agreed requirements through technical review and manufacturing-transfer preparation.
Defined Service Application
Product Development Planning and Execution Support
Connect product requirements, technical activities, testing, and manufacturing-transfer preparation through an integrated development plan. Scope the work to the product stage and the expertise of participating consultants and service providers.
Build the integrated development plan
Define work packages, milestones, partner responsibilities, dependencies, and decision points. Align development activities with quality, regulatory, supplier, and manufacturing requirements.
Coordinate technical execution
Track development outputs, testing activities, risk assessments, changes, and qualified review. Maintain requirements-to-evidence links and document unresolved inputs and review dispositions.
Prepare for manufacturing transfer
Assess outstanding requirements, supplier and manufacturing readiness, transfer documentation, and handoff criteria. Establish an action plan with responsible owners for remaining gaps.
Defined Deliverables
- Development plan
- Requirements-to-evidence matrix
- Risk and decision register
- Technical review records
- Transfer-readiness assessment
Pharmaceutical and biotechnology assignments may coordinate formulation, process and analytical development, CMC inputs, and manufacturing-partner deliverables. Device, diagnostic, and combination-product assignments may coordinate design inputs and outputs, risk-management interfaces, verification and validation activities, and design transfer. Hands-on engineering, laboratory work, and testing are scoped with appropriately qualified providers. Sponsor personnel and qualified specialists retain technical acceptance and regulated decision responsibilities.
AI Adoption and Process Evaluation
Establish suitable applications, operating controls, and personnel readiness; evaluate a selected task through a defined pilot.
Defined Service Application
AI Application and Readiness Assessment
Assess proposed AI applications in quality, regulatory, and program processes. Establish where the use is technically appropriate, what controls are required, and which prerequisites must be addressed before implementation.
Assess current processes
Review activities, current tools, source records, review requirements, and recurring preparation or coordination effort with the responsible process owners.
Evaluate proposed applications
Identify tasks suitable for preparation, comparison, or drafting support. Document limitations and decisions reserved for qualified personnel.
Determine prerequisites
Identify data-handling restrictions, approved-tool requirements, procedure changes, training needs, and any system assessment or validation activities required by the intended use.
Prioritize implementation
Deliver a prioritized application and readiness matrix with process owners, required controls, prerequisites, and proposed next steps. Use the assessment to focus investment on technically suitable applications.
Defined Deliverable
- Application
- Intended use
- Required controls
- Prerequisites
- Priority and owner
Deliverable: a prioritized application and readiness assessment for client selection and implementation planning.
Defined Service Application
AI Policy and Procedure Development
Establish documented controls for AI use within the client’s quality management system. Define approved applications, responsibilities, data handling, review, change control, and required records.
Define intended use and responsibilities
Specify approved and prohibited applications, authorized tools, process owners, and responsibilities for preparation, review, and approval.
Establish data and output controls
Define permitted source information, access and handling requirements, review criteria, exception handling, and escalation.
Integrate with the QMS
Identify affected procedures, forms, system controls, and training. Process proposed changes through the client’s document and change-control procedures.
Prepare the controlled procedure set
Deliver draft policy, procedures, and associated record requirements for client review and approval. Consistent instructions support repeatable execution and reduce avoidable deviations from approved practice.
Defined Deliverable
- Approved applications
- Responsibilities
- Data controls
- Review criteria
- Required records
Deliverable: a policy and procedure package for approval by client quality leadership and controlled implementation.
Defined Service Application
Role-Based Training on AI Use
Prepare personnel to use approved AI tools within their assigned responsibilities and applicable procedures. Instruction covers data handling, source verification, output review, documentation, and escalation.
Establish training requirements
Map approved applications and current procedures to the roles responsible for preparation, review, and approval.
Develop role-specific instruction
Prepare training material covering authorized tools, permitted data, task limitations, review requirements, and documentation practices.
Assess understanding
Define and administer an appropriate competency or understanding assessment. Record identified deficiencies and any required follow-up.
Document implementation and retraining
Record personnel completion against the applicable policy and training revisions. Define retraining triggers for changes in procedures, tools, or responsibilities.
Defined Deliverable
- Role
- Procedure revision
- Training material
- Assessment
- Completion record
Deliverable: role-based training material, assessment criteria, and completion records. Consistent instruction supports approved practice and reduces avoidable use errors; effectiveness is assessed within the engagement scope.
SCOPED PROCESS PILOT
AI-Assisted Process Evaluation
Evaluate AI support for a task you choose. Agree what success means, then measure accuracy, completeness, preparation time, review time, and rework against the starting point.
Define scope and deliverables
Specify the process, assessment question, deliverable format, exclusions, and engagement terms. Confirm applicable procedures, personnel training, and data-handling requirements before execution.
Establish source and review requirements
Identify approved source records and revisions, authorized tools, designated reviewers, and acceptance criteria.
Execute and document the assessment
Prepare the assessment or draft report with source references. Record missing information, discrepancies, revisions, and review dispositions in GAME Plan.
Assess performance against acceptance criteria
Evaluate source-reference accuracy, completeness, preparation and review time, repeat review cycles, and unresolved findings against the agreed baseline and acceptance criteria. Assess quality-related effort and rework within the pilot scope, then document the decision to modify the process, extend evaluation, or discontinue use.
Pilot Scope and Controls
- Defined deliverable
- Controlled sources
- Review responsibility
- Acceptance criteria
- Engagement terms
Deliverable: a documented pilot evaluation and next-step disposition. The pilot uses client-approved tools under expert supervision; scope, schedule, and commercial terms are agreed before execution.
Discuss the Pilot Scope →Quality-System Applications
Apply the same delivery method to quality-system work, with agreed inputs, qualified review, retained evidence, and measured results.
Defined Service Application
Procedure-to-Standard Gap Assessment
Assess the coverage of applicable requirements by controlled procedures and, where included in scope, supporting implementation records. Identify deficiencies and establish a prioritized remediation plan.
Define applicability and scope
Identify the process, applicable standard or regulatory requirements, assessment boundaries, and controlled source revisions. Document applicability decisions.
Assess procedures and implementation evidence
Map each applicable requirement to procedure sections and supporting records. Distinguish documented requirements from evidence that the process has been implemented.
Document and prioritize findings
Record gaps, inconsistencies, unavailable evidence, and the basis for each finding. Assign remediation priorities and responsible owners using agreed criteria.
Plan remediation and closure
Deliver the requirement-to-evidence matrix and action plan. Define the records and qualified review needed to demonstrate closure, supporting earlier correction and more efficient audit preparation.
Defined Deliverable
- Applicable requirement
- Procedure and evidence
- Finding
- Priority and owner
- Closure criteria
Deliverable: a scoped gap assessment, requirement-to-evidence matrix, and remediation plan. Document coverage alone does not establish process conformity; conclusions reflect the evidence reviewed and stated limitations.
DEPLOYED WORKFLOW
Audit SOP to Requirements
A deployed workflow for reviewing a controlled SOP against a defined set of applicable requirements. Map the procedure to the requirements, identify coverage and gaps, and prepare a source-referenced audit record for qualified review.
Set the audit scope
Identify the SOP and revision, the applicable requirements and their source revisions, and any scope or applicability decisions.
Map SOP content to requirements
Link each applicable requirement to the relevant SOP section. Record where coverage is present, incomplete, unclear, or absent, with references to the controlled sources.
Prepare findings for review
Organize the requirement mapping, potential gaps, and unresolved questions so a qualified reviewer can confirm findings and decide on any needed procedure changes.
Defined Deliverables
- SOP and source revisions
- Applicable requirements
- SOP section mapping
- Coverage and potential gaps
- Review dispositions
The mapping assesses the SOP content within the agreed scope. Qualified personnel confirm findings and retain responsibility for compliance conclusions, remediation, approval, and controlled changes.
Defined Service Application
Complaint Investigation and Report Preparation
Support review of complaint records, investigation documentation, and preparation of a report under the applicable complaint procedure. Preserve source references and document the basis and limitations of proposed conclusions.
Prepare controlled working records
Identify authorized source records and prepare working copies under the client’s access and data-handling procedures. Preserve relevant facts and a controlled reference to the original record; any redaction is documented and must not remove information required for the investigation.
Review facts and investigation evidence
Organize complaint details, product and lot information, investigation activities, and available technical findings. Identify discrepancies and missing inputs for follow-up.
Assess related events
Review related complaints within the defined period and classification criteria. Document recurrence or trend observations with the supporting data and assessment limitations.
Prepare and review the report
Prepare the investigation report with referenced findings, proposed conclusions, and follow-up items. Qualified client personnel determine the investigation disposition and any required reporting or escalation.
Defined Deliverable
- Source records
- Investigation findings
- Related-event assessment
- Outstanding items
- Review disposition
Deliverable: a source-referenced draft investigation report and outstanding-item list. Defined inputs and review criteria support completeness and reduce repeated clarification and revision.
Defined Service Application
CAPA Investigation and Documentation Support
Support CAPA investigation records, evaluation of proposed causes, action rationale, implementation evidence, and effectiveness assessment under the client’s CAPA procedure.
Prepare controlled working records
Identify authorized source records and prepare working copies under the client’s access and data-handling procedures. Preserve relevant facts and a controlled reference to the original record; any redaction is documented and must not remove information required for the investigation.
Evaluate the investigation and proposed causes
Organize the problem statement, extent assessment, investigation evidence, and cause analysis. Record the evidence supporting or contradicting proposed causes and identify unresolved questions.
Document actions and implementation
Connect proposed corrective and preventive actions to the evaluated causes. Define owners, completion dates, implementation records, and any required change-control activities.
Define effectiveness assessment and review
Document effectiveness criteria, assessment methods, timing, and required records. Prepare the CAPA documentation for qualified review; implementation completion alone does not demonstrate effectiveness.
Defined Deliverable
- Investigation evidence
- Cause evaluation
- Action rationale
- Implementation records
- Effectiveness criteria
Deliverable: a CAPA documentation package with unresolved questions, action requirements, and effectiveness-assessment criteria. Earlier identification of documentation deficiencies supports reduced rework; client personnel approve causes, actions, effectiveness conclusions, and closure.
Defined Service Application
Procedure-Based Training Development and Implementation
Develop training material from controlled procedures and coordinate implementation through the client’s existing training process. Client-approved tools may support preparation.
Map procedures to training requirements
Identify the applicable SOPs and work instructions, current revisions, affected roles, and required learning objectives.
Prepare source-referenced material
Develop training content and assessments linked to the approved procedure revision. Identify questions requiring subject-matter clarification.
Review and release controlled material
Obtain designated technical review and approval. Apply the client’s document-control and change-control requirements to training updates.
Coordinate assignments and completion records
Support assignment, completion tracking, and assessment records within the existing training process. Maintain procedure-to-training links to reduce revision-related rework and missed training updates.
Defined Deliverable
- Procedure revision
- Affected roles
- Approved material
- Assessment
- Completion records
Deliverable: procedure-linked training material, assessments, and an implementation record. LMS configuration or software deployment requires a separate agreement.
DEPLOYED WORKFLOW
Procedure from Spec — Regulated SOP Drafting
Turn an agreed process specification into a regulated SOP draft. The deployed workflow uses the sponsor’s defined process, applicable requirements, approved sources, and document template to prepare a procedure for accountable human review.
Define the procedure specification
Agree on purpose, scope, process steps, roles, required records, applicable requirements, approved sources, and the sponsor’s template.
Draft the procedure from the specification
Translate the agreed specification into a procedure draft. Retain references to the specification and sources, and expose missing inputs or unresolved requirements for review.
Review, approve, and release
The process owner and qualified reviewers assess the draft against the specification and applicable requirements. The sponsor retains approval, change control, training, and controlled-release responsibilities.
Defined Deliverables
- Agreed process specification
- Source-referenced SOP draft
- Requirements and open items
- Review dispositions
- Controlled-release requirements
The workflow supports drafting; it does not approve an SOP or establish that the process is compliant or implemented.
DEPLOYED WORKFLOW
Quality Metrics
A deployed workflow for organizing quality metrics around sponsor-defined processes and oversight needs. Agree on definitions, sources, review responsibilities, and the decisions the metrics are intended to support.
Define measures and sources
Agree on metric definitions, source records, reporting scope, and accountable owners.
Prepare and review metrics
Organize the data and derived measures, retain source references, and identify missing inputs or interpretation limits for qualified review.
Use the reviewed results
Present metrics and trends for process oversight and management review. Qualified personnel retain responsibility for interpretation and resulting decisions.
Defined Deliverables
- Metric definitions
- Source records
- Reviewed measures
- Trends and limitations
- Management-review inputs
The application is mapped to the sponsor’s own quality processes; metrics do not replace investigation, technical judgment, or regulated decision authority.
Durable-Agent Development Roadmap
Develop a configured workflow around your selected responsibilities, sources and review requirements. These proposed profiles extend the roadmap; existing service and workflow availability remains as identified above.
AVAILABLE FOR SCOPED DEVELOPMENT
Develop a Durable Agent Around Your Workflow
Commission a scoped development engagement using the existing workflow specifications as a starting point. Define the agent’s responsibilities, permitted information and actions, continuing work state and qualified review before selecting the implementation.
Specify the workflow and acceptance
Agree the sponsor-selected problem, source rights, trigger, deliverables, named reviewer, pause/stop rules and acceptance criteria. Select a proposed profile or define another supported workflow.
Develop and integrate the selected profile
Configure and implement the required source access, work continuity, evidence and review interfaces. Agree scope, resources, schedule and commercial terms; qualify each required connection.
Test, review and decide on deployment
Evaluate source changes, interruption recovery, access denial and handover, alongside output quality and full preparation/review cost. Operational deployment requires separate intended-use acceptance.
Proposed Workflow Profiles
- Complaint investigation coordinator
- CAPA coordinator
- Procedure steward
- Audit coordinator
- Quality metrics steward
Development availability does not mean the profiles are already deployed or accepted for regulated use. Qualified sponsor personnel retain conclusions, approvals and controlled-system changes. The initial CQ profile scope is read-only; recurring operation and cross-organization automation require their applicable runtime and integration acceptance.
Additional Technical Services
Program and Portfolio Management
Coordinate priorities, dependencies, resources, milestones, and decisions across projects and participating organizations. Assess delayed programs and establish a documented recovery plan.
Technical and Controlled Documents
Prepare and coordinate procedures, technical reports, and controlled documents using defined sources, subject-matter review, revision control, and approval requirements.
Supplier and Service-Provider Oversight
Connect contractual and quality obligations to deliverables, performance records, changes, acceptance criteria, and escalation responsibilities.