qms-change-control

Change Control

Assess. Approve. Implement.

Approval is easy. Implementation is where change control fails. Track every affected document, training requirement, and validation until the change is truly complete.

Change Control

Approved but never finished.

CC-2024-047 was approved on January 15th. R&D signed off. QA signed off. Operations signed off. Approval workflow completed in three days.

Six months later, an auditor asked to see the SOP that was supposed to be updated. It still showed the old process. The training that was supposed to happen? Never happened. The validation protocol? Never executed.

The change was approved. It was never implemented.

Implementation Tracking

Approval is the beginning

Most change control systems end at approval. They tell you a change was approved, but not whether it was implemented. Implementation is where organizations fail.

The lifecycle

Change control lifecycle

Initiation → Impact assessment → Approval → Implementation → Effectiveness review.

The change doesn't close until every implementation task is complete with documented evidence. If an SOP update is assigned to someone who goes on leave, the system escalates.

Connected impact assessment

When you propose a change, the system identifies affected items automatically:

  • SOPs, work instructions, batch records that reference the changed item
  • Personnel who need retraining based on their job roles
  • Equipment or processes that may need requalification
  • Regulatory filings that reference the changed item

This isn't a checklist. It's computed from your actual data relationships.

Change classification

Major changes: cross-functional review, extensive implementation. Minor changes: streamlined review. Administrative changes: minimal review.

Classification drives workflow automatically.

Emergency changes

Equipment fails. A supplier discontinues a material. Designated personnel can authorize emergency implementation while formal approval proceeds in parallel. The change happens first; the documentation catches up.

Effectiveness review

Three months after implementation: did it work? Seal schedules automatic effectiveness reviews. If the change didn't achieve its purpose, that's captured. If it created new problems, those need addressing.

Capabilities

01Connected Impact Assessment
System traces relationships to identify affected documents, training, validation, and regulatory filings automatically.
02Implementation Tracking
Every implementation task tracked with owner, deadline, and evidence. Change can't close until all tasks complete.
03Configurable Classification
Major, minor, administrative categories with appropriate workflows. Right level of rigor for each change type.
04Emergency Change Support
Expedited workflows for urgent changes. Immediate authorization with retrospective documentation.
05Effectiveness Review
Automatic scheduling of follow-up assessments. Verify changes achieved their intended outcomes.
06Regulatory Traceability
Link changes to regulatory submissions. Know when a change requires filing updates or agency notification.
07AI Impact Analysis
AI suggests impacts you might miss based on data relationships and historical changes. Human review, AI assistance.
08External Change Triggers
Supplier notifications, customer requirements, and regulatory updates initiate change control automatically.
01 / 08
Connected Impact Assessment
Connected Impact Assessment

Entities

Entity
Description
Kind
Change Request
Approval authorizes the change. It doesn't make it real. The actual work happens after.
type
Major Change
Full cross-functional review. R&D, QA, Regulatory, Operations all approve. Extensive implementation tracking.
template
CC-2024-047
Approved January 15. SOP still shows old process. Training never happened. Change approved, never implemented.
instance
Minor Change
Streamlined workflow. QA and process owner. Still tracked, but appropriate rigor.
template
Emergency Change
Equipment failed. Material discontinued. Implement now, document after. But it does catch up.
template
Supplier Change
External notification becomes internal response. Same rigorous process.
template
Implementation Task
SOP updated? Personnel retrained? Equipment modified? Change can't close until every task is complete with evidence.
type
Document Update
SOP revision required. If assignee goes on leave, system escalates. Task doesn't disappear.
template
Update SOP-042
Assigned. Deadline passed. Assignee on leave. No escalation. Six months later: still old version.
instance
Training Task
Four operators need retraining. Previous version obsolete. Training deadline tracked.
template
Effectiveness Review
Three months later: did it work? Did the improvement actually improve? If not, that's valuable learning.
type
Impact Assessment
System traces relationships automatically. Which SOPs reference this equipment? Who needs retraining? What validations are affected?
type
Affected Item
Live links, not text in paragraphs. Equipment XYZ changed → these 12 batch records reference it.
type
External Trigger
Supplier notification, customer requirement, regulatory update. External change triggers internal response.
type

FAQ

Seal's connected data model means changes automatically trace to all affected items across the platform. A change to equipment impacts batch records in MES, procedures in document control, and training in the LMS. You see the complete impact, not just what's in the change control silo.