Project Development &amp; Documentation

FDA regulation for electronic records and signatures in pharmaceutical.

A

1 term

As-Built Documentation

Final documentation reflecting actual installed system configuration.

B

1 term

Baseline

Approved project reference point for measuring changes.

C

4 terms

Cause and Effect Matrix

C&E

Table showing relationship between process inputs and safety outputs.

Change Management

Process for controlling modifications to validated systems.

Commissioning

Process of verifying and documenting that equipment operates as designed.

Configuration Management

Systematic handling of changes to maintain system integrity.

D

2 terms

Deliverable

Beginner

Tangible output or result required from project phase.

Detailed Design Specification

DDS

Comprehensive technical documentation for system implementation.

E

1 term

Electrical Schematic

Diagram showing electrical connections and components in system.

F

3 terms

FAT (Factory Acceptance Test)

FAT

Testing at manufacturer's facility before shipment to verify system meets specifications.

FDS (Functional Design Specification)

FDS

Document describing how system will meet user requirements.

FMEA

Failure Mode and Effects Analysis for systematic risk assessment.

G

2 terms

GAMP 5

Good Automated Manufacturing Practice guidelines for validated systems.

Git

Distributed version control system for tracking code changes.

H

1 term

HAZOP

Hazard and Operability study identifying potential hazards in design.

I

2 terms

I/O List

BeginnerEssential

Spreadsheet documenting all input/output points with descriptions and addresses.

IQ/OQ/PQ

Installation/Operational/Performance Qualification for validated systems.

L

2 terms

Lessons Learned

Beginner

Documentation of project insights for future improvement.

Loop Diagram

Drawing showing complete signal path from field device to control system.

M

1 term

Milestone

Beginner

Significant project checkpoint marking phase completion.

P

1 term

Punch List

List of items needing completion before project acceptance.

R

2 terms

Red-line Drawings

Marked-up drawings showing field changes during construction.

Risk Assessment

Systematic evaluation of potential hazards and their mitigation.

S

3 terms

SAT (Site Acceptance Test)

SAT

Final testing at customer site confirming system operates correctly in actual environment.

Scope Creep

Uncontrolled expansion of project requirements after start.

SOP (Standard Operating Procedure)

SOP

Written instructions for performing routine operations.

T

3 terms

Technical Specification

Detailed document defining technical requirements and design.

Test Protocol

Step-by-step procedure for verifying system functionality.

Traceability Matrix

Document linking requirements to test cases and implementation.

U

1 term

URS (User Requirement Specification)

URS

Document defining what user needs from system without specifying how.

V

1 term

Version Control

System tracking changes to code and documentation over time.