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获取原文件assets/templates/procedures/document-control-procedure-template.md
STATUS: DRAFT EXAMPLE — NOT APPROVED — NO COMPLIANCE CLAIM
This structure is not a released procedure. It does not determine retention, regulatory applicability, conformity, or certification. Authorized management, RA/QA, legal/regulatory, process owners, and document control must approve the organization-specific controls. ISO publications are copyrighted; use an authorized copy and do not paste their text here.
Controlled-document metadata
| Field | Entry |
|---|---|
| Document ID/revision | <ID> / <revision> |
| Owner | <accountable role> |
| Status | draft / in-review / approved |
| Effective date | <YYYY-MM-DD after approval> |
| Evidence repository | <controlled location> |
| Change/superseded record | <IDs> |
| Approval role | Named approver | Status | Date | Approval evidence |
|---|---|---|---|---|
| Process owner | <name/role> |
pending |
<date> |
<ID> |
| RA/QA | <name/role> |
pending |
<date> |
<ID> |
| System owner | <name/role> |
pending |
<date> |
<ID> |
1. Purpose, scope, and interfaces
- Controlled documents covered:
<types, systems, sites, products> - Records covered:
<types, systems, sites, products> - External sources covered: standards, regulations, guidance, customer and supplier specifications, and product-specific sources.
- Interfaces: change control, training, validation, data integrity, cybersecurity, supplier controls, product files, complaints/CAPA, audit, and management review.
2. Roles and segregation of duties
| Role | Authority/responsibility | Independence or access restriction | Delegate | Evidence | Approval |
|---|---|---|---|---|---|
| Document owner | <entry> |
<entry> |
<role> |
<ID> |
<ID> |
| Record owner | <entry> |
<entry> |
<role> |
<ID> |
<ID> |
| Reviewer | <entry> |
<entry> |
<role> |
<ID> |
<ID> |
| Approver | <entry> |
<entry> |
<role> |
<ID> |
<ID> |
| System administrator | <entry> |
<entry> |
<role> |
<ID> |
<ID> |
3. Document lifecycle
| Stage | Required controls | Owner | Status | Evidence | Approval |
|---|---|---|---|---|---|
| Request/authoring | need, scope, source/version, author | <role> |
draft |
<ID> |
<ID> |
| Review | technical, process, RA/QA, linked-document impact | <role> |
draft |
<ID> |
<ID> |
| Approval/release | named authority, date, revision, effective date | <role> |
draft |
<ID> |
<ID> |
| Distribution/use | access, point-of-use revision, copy status | <role> |
draft |
<ID> |
<ID> |
| Change | rationale, impact, validation/training, linked updates | <role> |
draft |
<ID> |
<ID> |
| Obsolescence | withdrawal, archive, retained-copy identification | <role> |
draft |
<ID> |
<ID> |
Define approved rules for identifiers, revision schemes, emergency changes, printed copies, translations, electronic signatures, and controlled exports. Do not assume that a downloaded or printed file remains controlled.
4. Record lifecycle and data integrity
| Control | Organization-specific method | Owner | Status | Evidence | Approval |
|---|---|---|---|---|---|
| Creation/attribution | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Legibility/completeness | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Contemporaneous entry | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Corrections/audit trail | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Access/security | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Backup/recovery | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Retrieval | <entry> |
<role> |
draft |
<ID> |
<ID> |
| Retention/disposition | <entry> |
<role> |
draft |
<ID> |
<ID> |
Retention periods must cite an approved basis for each record type. This template does not supply a universal period.
5. External source and version control
| Source ID | Publisher/title | Version/date | Authorized location | Applicability owner | Last currency review | Impact record | Status | Approval |
|---|---|---|---|---|---|---|---|---|
<ID> |
<entry> |
<entry> |
<entry> |
<role> |
<date> |
<ID> |
review-due |
<ID> |
Required controls:
- Obtain standards from an authorized source and preserve license restrictions.
- Record the exact edition/version incorporated into each jurisdictional basis.
- Monitor official publishers; do not rely on search snippets as controlled text.
- Perform and approve impact assessment before changing QMS documents.
- Distinguish ISO, FDA QMSR/eCFR, MDSAP, EU MDR/IVDR/MDCG, and product-specific sources rather than treating them as interchangeable.
6. Electronic systems and software validation
| System/use | Intended use | Risk basis | Access/audit-trail controls | Validation evidence | Change/revalidation trigger | Owner | Approval |
|---|---|---|---|---|---|---|---|
<system> |
<entry> |
<entry> |
<entry> |
<ID> |
<entry> |
<role> |
<ID> |
Do not release an electronic workflow until authorized owners approve intended use, validation evidence, access roles, data migration, backup/recovery, and change controls.
7. Change and training impact
Every change record should include:
- reason, affected products/sites/processes/documents/records;
- source/version and regulatory-impact review;
- risk, validation, software, supplier, and postmarket impacts;
- training population and completion evidence before effective use;
- implementation verification, owner, status, evidence, and approval.
8. Registers and audit evidence
| Register | Owner | Status | Location | Review frequency/basis | Evidence | Approval |
|---|---|---|---|---|---|---|
| Master document list | <role> |
draft |
<location> |
<basis> |
<ID> |
<ID> |
| Record retention schedule | <role> |
draft |
<location> |
<basis> |
<ID> |
<ID> |
| External source ledger | <role> |
draft |
<location> |
<basis> |
<ID> |
<ID> |
| Access/role register | <role> |
draft |
<location> |
<basis> |
<ID> |
<ID> |
| Training/change register | <role> |
draft |
<location> |
<basis> |
<ID> |
<ID> |
| Obsolete/disposition log | <role> |
draft |
<location> |
<basis> |
<ID> |
<ID> |
Release checklist
- Scope includes documents, records, external sources, and electronic systems.
- Owners, statuses, evidence, source versions, and approvals are explicit.
- Access, integrity, retrieval, retention, disposition, and audit trails are defined.
- Change, validation, software, supplier, and training impacts are linked.
- No universal retention period or automatic applicability conclusion is asserted.
- No template or script result is described as compliance or certification.
- Required human approvals are complete before the effective date.