設訓計

立依職之 GxP 訓計，含課、能評、記管，以備受管境。

用

• 新驗系上線前宜訓使者
• 審現斥訓不足或記缺
• 組變引新職責
• 定期復訓計
• 監察備需證訓足

入

• 必：宜訓者之系及程
• 必：職定（管者、使者、QA、首）
• 必：適訓之規範（GMP、GLP、GCP）
• 可：既有訓材或課
• 可：審或效現之能缺
• 可：訓管系之能

行

一：作訓需析

識諸職所宜知：

# Training Needs Analysis
## Document ID: TNA-[DEPT]-[YYYY]-[NNN]

### Role-Based Training Requirements

| Role | GxP Awareness | System Training | Data Integrity | SOP Training | Assessment Type |
|------|--------------|----------------|----------------|--------------|-----------------|
| System Administrator | Advanced | Advanced | Advanced | Admin SOPs | Written + Practical |
| End User | Basic | Intermediate | Intermediate | Operational SOPs | Written + Practical |
| QA Reviewer | Advanced | Basic (review focus) | Advanced | QA SOPs | Written |
| Management | Basic | Overview only | Intermediate | Governance SOPs | Written |
| IT Support | Basic | Infrastructure only | Basic | IT SOPs | Written |

### Training Gap Analysis
| Role | Current Competency | Required Competency | Gap | Priority |
|------|-------------------|---------------------|-----|----------|
| [Role] | [Current level] | [Required level] | [Gap description] | [H/M/L] |

得：諸職皆有訓求繫於其職與 GxP 責。

敗：職未明→先作 RACI 以立責，後定訓需。

二：設課

依題分訓為模：

# Training Curriculum
## Document ID: TC-[DEPT]-[YYYY]-[NNN]

### Module 1: GxP Regulatory Awareness
**Duration:** 2 hours | **Delivery:** Classroom / eLearning | **Audience:** All roles
**Content:**
1. Introduction to GxP regulations (GMP, GLP, GCP overview)
2. 21 CFR Part 11 and EU Annex 11 requirements for electronic records
3. Data integrity principles (ALCOA+)
4. Consequences of non-compliance (warning letters, consent decrees, product recalls)
5. Individual responsibilities and accountability

### Module 2: System-Specific Training — [System Name]
**Duration:** 4 hours | **Delivery:** Instructor-led with hands-on | **Audience:** Users, Admins
**Content:**
1. System purpose and GxP classification
2. Login, navigation, and role-based access
3. Core workflows (step-by-step for each user task)
4. Electronic signature procedures
5. Audit trail: how entries are created and what they mean
6. Error handling and deviation reporting
7. Data entry best practices

### Module 3: Data Integrity in Practice
**Duration:** 1.5 hours | **Delivery:** Workshop | **Audience:** Users, QA, Admins
**Content:**
1. ALCOA+ principles with system-specific examples
2. Common data integrity risks and how to avoid them
3. Recognising and reporting data integrity concerns
4. Audit trail review basics
5. Case studies: real-world data integrity failures and lessons learned

### Module 4: SOP Training — [SOP-ID]
**Duration:** 1 hour per SOP | **Delivery:** Read and sign / walkthrough | **Audience:** Per SOP scope
**Content:**
1. SOP purpose and scope
2. Step-by-step procedure walkthrough
3. Decision points and deviation handling
4. Forms and documentation requirements
5. Q&A and clarification

得：各模有定時、交法、聽眾、具體內容綱。

敗：內過廣於配時→分為子模或立先修鏈。

三：立能評

定各模如何量能：

# Competency Assessment Design

### Assessment Types
| Type | When to Use | Passing Score | Records |
|------|------------|---------------|---------|
| **Written test** | Knowledge assessment (regulations, principles) | 80% | Score sheet retained |
| **Practical demonstration** | Skill assessment (system operation) | All critical steps correct | Signed observation form |
| **Observed task** | On-the-job competency | Supervisor sign-off | Competency form |

### Sample Written Assessment — GxP Awareness (Module 1)
1. List the five ALCOA principles for data integrity. (5 points)
2. Under 21 CFR 11.50, what three elements must an electronic signature display? (3 points)
3. You discover that a colleague's data entry contains an error. Describe the correct procedure to correct it. (5 points)
4. True/False: A shared login account can be used if all users sign a logbook. (2 points — answer: False)
5. Describe one consequence of a data integrity failure for a pharmaceutical company. (5 points)

**Passing score:** 16/20 (80%)
**On failure:** Retraining required before re-assessment. Maximum 2 re-attempts.

### Practical Assessment Template
| Step | Task | Observed? | Performed Correctly? | Comments |
|------|------|-----------|---------------------|----------|
| 1 | Log in with personal credentials | Yes/No | Yes/No | |
| 2 | Navigate to [specific function] | Yes/No | Yes/No | |
| 3 | Enter test data correctly | Yes/No | Yes/No | |
| 4 | Apply electronic signature | Yes/No | Yes/No | |
| 5 | Locate and interpret audit trail | Yes/No | Yes/No | |

**Assessor:** _______ **Date:** _______ **Result:** Pass / Fail

得：評測知（解何以）與能（示如何）。

敗：過率低於 70%→先省訓材之明而勿咎學者。

四：定訓記與留

# Training Record Management

### Required Training Records
| Record | Format | Retention Period | Storage |
|--------|--------|-----------------|---------|
| Training matrix (who needs what) | Electronic | Current + 2 years superseded | Training management system |
| Individual training transcript | Electronic | Employment + 2 years | Training management system |
| Assessment results | Electronic or paper | Same as transcript | Training management system |
| Training materials (version used) | Electronic | Life of system + 1 year | Document management system |
| Trainer qualification records | Electronic | Employment + 2 years | HR system |

### Training Matrix Template
| Employee | Role | Module 1 | Module 2 | Module 3 | SOP-001 | SOP-002 | Status |
|----------|------|----------|----------|----------|---------|---------|--------|
| J. Smith | User | 2026-01-15 ✓ | 2026-01-16 ✓ | Due 2026-03-01 | 2026-01-20 ✓ | N/A | Partially trained |
| K. Jones | Admin | 2026-01-15 ✓ | 2026-01-17 ✓ | 2026-01-18 ✓ | 2026-01-20 ✓ | 2026-01-20 ✓ | Fully trained |

得：訓記示諸行 GxP 事者皆於前受訓並評。

敗：訓記缺→作回溯訓缺析並施速補訓。

五：定重訓觸

# Retraining Triggers

| Trigger | Scope | Timeline | Assessment Required? |
|---------|-------|----------|---------------------|
| SOP revision (minor) | Affected users — read and sign | Before new version effective | No — read and acknowledge |
| SOP revision (major) | Affected users — formal retraining | Before new version effective | Yes — written or practical |
| System upgrade | All users of affected functionality | Before production go-live | Yes — practical demonstration |
| Data integrity incident | Involved personnel + department | Within 30 days of investigation closure | Yes — written |
| Audit finding (training-related) | Per CAPA scope | Per CAPA timeline | Per CAPA requirements |
| Annual refresher | All GxP personnel | Annual from initial training date | No — refresher acknowledgement |
| Role change | Individual | Before assuming new responsibilities | Yes — per new role requirements |
| Extended absence (>6 months) | Returning individual | Before resuming GxP activities | Yes — practical assessment |

得：重訓觸具體、可量、繫於定時。

敗：重訓未於觸期前畢→該員勿行該 GxP 事至訓畢。

六：合編訓計文

# Training Programme
## Document ID: TRAINING-PROGRAM-[DEPT]-[YYYY]-[NNN]

### 1. Purpose and Scope
### 2. Training Needs Analysis [Step 1]
### 3. Curriculum [Step 2]
### 4. Competency Assessments [Step 3]
### 5. Training Records and Retention [Step 4]
### 6. Retraining Triggers [Step 5]
### 7. Programme Review
- Annual review of training effectiveness (pass rates, audit findings, incidents)
- Curriculum update when systems, SOPs, or regulations change
- Trainer qualification verification

### 8. Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Training Manager | | | |
| QA Director | | | |
| Department Head | | | |

得：全訓計於系上線或合規限前批並行。

敗：批延→施臨時訓並書正式化之計。

驗

• 諸與 GxP 系接觸之職已作訓需析
• 課模已定時、交法、內綱
• 各模有能評及過標
• 訓矩追諸員對諸訓
• 訓記留符規範
• 重訓觸已定時線及評求
• 訓計經 QA 及首批

忌

• 訓＝讀 SOP：讀並籤宜於小改，非初訓→新員宜師授含實操
• 無能評：訓而無評不證學成→監察求能證而非僅出席
• 訓師無資：訓師宜能證於題→「訓訓師」記常於監察時索
• 陳訓矩：員入、離、改職時訓矩未更→致合規缺→與 HR 程整合
• 一統而全：管者需更深之訓→依職之課避某員溺而他員不足

參

• write-standard-operating-procedure
• design-compliance-architecture
• conduct-gxp-audit
• manage-change-control
• prepare-inspection-readiness