Free Templates: - For More...* Templates, please login *

QMS - HR - Warehouse - Facilities - QC & Labs - Validation - IT - Process - Clinical

  • Test Cases -

Templated ready procedures developed and ready for implementation for Pharmaceutical,Medical Device, Dietary Supplements, and Cosmetic Industry - CALL For DETAILS!

Manufacturing/Processing, Laboratories, Storage, Distribution, Packaging and Compounding
- - Corporate Quality Policy and Quality Mission Statements - Template 1 - Template 2 - Template 3
- - Quality Manuals - Specific for your Industry - Template 1 - Template 2 - Template 3
- - Validation Master Plan - Corporate Validation Methodology - Template 1 - Template 2
- - Facility Qualification Plans and Facility Site Master Plans and Files - Template 1 - Template 2
- - Corporate Risk Statements - Template 1 - Template 2
- - SOP Templates - Template 2 - Template 3 - Template 4 - Template 5
 
Other Templates:
- - Audit Reports - Template 1 - Template 2 - Template 3 - Template 4 - More...*

- - Validation Protocols (Equipment, Methods, Facilities, Process, Cleaning)

- - Quality Manuals - Template 1 - Template 2 - More...*
- - Device Master Records - Template 1 - Template 2 - More...*
- - Drug Master Files - Template 1 - Template 2 - More...*
- - IT Strategy Plans - Template 1 - Template 2 - More...*
- - 21 CFR Part 11 Charter - Template 1 - Template 2 - More...*
- - Human Resource Manual - Template 1 - Template 2 - More...*
- - Employee Safety Guide (Basic ESH and OSHA Required) - Template 1 - Template 2
 
Not all may apply, based upon applicability
(F - With Associated Forms)
- QMS Procedures * Requires Login
  - - - Standard Operating Procedures - SOP/WI (F) (See Above) - More...*
  - - - Requesting, Writing and Challenging Procedures (F) - More...*
  - - - Risk Management (F) - More...*
  - - - Corrective and Preventative Actions (CAPA) (F) - More...*
  - - - Non-Conformance (F) - More...*
  - - - Change Control (F) - More...*
  - - - Deviations (F) - More...*
  - - - Complaints Management (F) - More...*
  - - - Recalls and Recall Challenge (F) - More...*
  - - - Quality Assurance Procedures (other) - More...*
  - - - Internal Audit (F) - More...*
  - - - External Audit (F) - More...*
  - - - Agency Audit - More...*
  - - - Customer Audit - More...*
  - - - Traceability (F) - More...*
  - - - Good Documentation Practice (GDocP) Standards - More...*
  - - - Document Management and Document Control (F) - More...*
  - - - Document Management Archive and Disposition (F) - More...*
  - - - Form Management (F) - More...*
  - - - Logbook Control and Quality Review - More...*
  - - - Out of Specification (OOS) (F) - More...*
  - - - Contractors - More...*
  - - - Regulatory Affairs - More...*
  - - - Product Safety - More...*
  - - - Reporting to Regulatory Agencies - More...*
  - - - Audit Reports - More...*
  - - - Annual Product Review - More...*
  - - - Annual and Preschedule Quality Meetings (Review) (F) - More...*
  - - - Out of Trending / Out of Tolerance (OOT) (F) - More...*
  - - - Rework and Reprocessing (F) - More...*
  - - - Managing Visitors (F) - More...*
  - - - Pharmacy Operations - More...*
  - - - Compounding - More...*
  - - - Disaster Recovery and Business Continuity (F) - More...*
  - - - Signature Logs - More...*
  - - - Review of Quality Documents (Batch/Assembly Records) - More...*
  - - - Review of Quality Critical Documents - More...*
  - - - Review of Contracts and Scope of Work Agreements - More...*
  - - - Vendor Qualifications (F) - More...*
  - - - HACCP Management - More...*
  - - - Research and Development - More...*
  - - - Pilot Plant Scalability - More...*
  - - - Process Improvement - More...*
 
- Human Resources * Requires Login
  - - - Training and Development - More...*
  - - - Hiring and Releasing - More...*
  - - - CV Management - More...*
  - - - Roles, Responsibilities and Job Descriptions - More...*
  - - - Employment - More...*
  - - - GMP Training Curriculum with Curriculum - More...*
  - - - GLP Training Curriculum with Curriculum - More...*
  - - - GCP Training Curriculum with Curriculum - More...*
  - - - Employee Safety - More...*
  - - - Background Checks and Drug Testing - More...*
  - - - Regulation of Food, Drink and Smoking - More...*
  - - - New Employee Orientation - More...*
 
- Warehouse, Receiving and Shipping * Requires Login
  - - - Receiving - Materials - More...*
  - - - Quarantine - Incoming and Finished Products - More...*
  - - - Rejected Materials - More...*
  - - - Sampling - Area Management - More...*
  - - - Inventory Control - Cycle Counting and Reconciliation - More...*
  - - - Label Management and Label Control - More...*
  - - - Retains - Area and Inventory Management - More...*
  - - - Reserves - Area and Inventory Management - More...*
  - - - Experimental - Area and Inventory Management - More...*
  - - - Returns - Area and Inventory Management - More...*
  - - - FIFO - First In - First Out Management - More...*
  - - - Waste - Area and Inventory Management - More...*
  - - - Cleaning - Area - More...*
  - - - Shipping - Area Management - More...*
  - - - Controlled Environments and Area Management - More...*
  - - - Sterilization - More...*
  - - - Serialization - More...*
 
- Facilities * Requires Login
  - - - Asset Management - More...*
  - - - Maintenance and Preventive Maintenance Management - More...*
  - - - Work Order Management - More...*
  - - - Pest Control - More...*
  - - - Metrology and Calibration Management - More...*
  - - - Engineering and Engineering Change Management - More...*
  - - - Drawings, Schematics and Flow Diagram Management - More...*
  - - - Contractors and Consultants - More...*
  - - - Environmental, Safety and Health - More...*
  - - - Temperature / Humidity Management - More...*
  - - - Building Monitoring/Management Systems - More...*
  - - - Filter Management - More...*
  - - - Balancing Load Management - More...*
  - - - Housekeeping and Janitorial - More...*
  - - - Plant/Facility Security Management - More...*
  - - - Control Substance Management - More...*
  - - - Biological Product Management (BLS 1,2&3) - More...*
  - - - Emergency Safety Evaluation - More...*
  - - - Handling of Hazardous Materials - More...*
  - - - Handling of Flammable Materials - More...*
  - - - Drain Cleaning and Sanitization - More...*
  - - - Cleaning and Maintaining Air Handling Equipment and Ducting - More...*
  - - - Gowning and De-gowning Procedures - More...*
  - - - Use of Approved Cleaning Chemicals - More...*
  - - - Redundant Systems (Generators, Grids and UPS systems) - More...*
  - - - Compressed Air Systems (General Use and Process) - More...*
  - - - Compressed Gas Systems - More...*
  - - - Vacuum Systems - More...*
 
- Quality Control and Laboratories * Requires Login
  - - - Sampling Incoming and Finished Products and Materials Receipt - More...*
  - - - Sampling, Testing & Approval or Rejection of Components - More...*
  - - - Sampling, Testing & Approval or Rejection of Active and Inactive ingredients - More...*
  - - - In-Process Control Points - More...*
  - - - Batch or Assembly Record Review and Verification - More...*
  - - - Sample and Test Article Management - More...*
  - - - Balances and Scales - More...*
  - - - Laboratory Information Management System - More...*
  - - - Electronic Notebook System - More...*
  - - - Reagent Management - More...*
  - - - Column Management - More...*
  - - - Test Samples - More...*
  - - - Qualification and Validation - More...*
  - - - Contractors - More...*
  - - - Stabilities and Stability Management - More...*
  - - - Water Systems Testing, Potable, Purified and WFI Systems - More...*
  - - - Microbiology and Sterility Testing - More...*
  - - - Reporting and Record Management - More...*
  - - - Verification Process - More...*
  - - - Disposal of Process Waste and Effluent - More...*
  - - - Release of Finished Materials - More...*
  - - - Quality Agreements - More...*
 
- Validation/Qualification * Requires Login
  - - - Process Validation - More...*
  - - - Equipment Validation - More...*
  - - - Software and Computer Systems/Hardware Validation - More...*
  - - - Cleaning Validation - More...*
  - - - Facility Qualifications - More...*
  - - - Method and Analytical Process Validation - More...*
 
- IT and Electronic Systems * Requires Login - Total Package Price $22,000
  - - - Backup and Recovery - More...*
  - - - Disaster Recovery and Business Continuity - More...*
  - - - Backup and Recovery Challenging Process - More...*
  - - - Upgrade and Downgrade - More...*
  - - - Change Control - More...*
  - - - Configuration Management - More...*
  - - - Software / Systems Development Life Cycle  - More...*
  - - - Development of Software/Systems User Requirements Specifications (URS) - More...*
  - - - Development of Software/Systems Functional Requirement Specifications (FRS) - More...*
  - - - Software Use Policies and Internet Usage - More...*
  - - - Software Risk Assessment - More...*
  - - - Hardware Risk Assessment - More...*
  - - - Network Access Policies - More...*
  - - - New Hardware Installation - More...*
  - - - New Software Installation - More...*
  - - - Hardware Maintenance - More...*
  - - - Software Maintenance - OEM and Internal - More...*
  - - - Computer Systems Hardware Testing and Validation - Writing Installation Qualifications, Operational Qualifications, and Performance Qualifications - More...*
  - - - Computer Systems Software Testing and Validation - Writing Installation Qualifications, Operational Qualifications, and Performance Qualifications - More...*
  - - - 21 CFR Part 11 Electronic Systems / EU Annex 11 Computer Systems - More...*
  - - - Virus Protection, Log reviews and Definitions updating processes - More...*
  - - - UPS and Redundant Power Supply - More...*
  - - - Imaging of computer systems (Clients and Servers) - More...*
  - - - Data Base Administrator (DBA) Procedures - More...*
  - - - Ghosting and/or Mirroring Processes - More...*
  - - - MS Excel Qualification - More...*
  - - - Off Site Storage - More...*
  - - - Tape Management, Chain of Custody and Degaussing Procedure - More...*
  - - - Internal Systems Audit - More...*
  - - - Vendor Qualifications, Hardware, Software, Consultants and Contractors,  ASPs/ISPs/IaaS/SaaS - More...*
  - - - Administrative Rights - More...*
  - - - Database Administrative Activities - More...*
  - - - Physical Security - More...*
  - - - Computer Room Management and Alarming Systems - More...*
  - - - Computer Room Environmental Systems and Alarming Systems - More...*
  - - - Help Desk Management - More...*
  - - - Drawing, Schematics, Flow Diagrams and other Quality Critical Documents - More...*
  - - - Good Programming Practices - More...*
  - - - Code Management - More...*
  - - - Test Platforms - More...*
  - - - Qualification and Validation - More...*
 
- Manufacturing and Processing * Requires Login
  - - - Device History Files (DHF) - More...*
  - - - Device Master Records (DMR) - More...*
  - - - Batch Record Management (BRM) - More...*
  - - - Batch Master Records (BMR) - More...*
  - - - Dispensing of Materials - More...*
  - - - Cleaning of Equipment (Cleaning Qualification) - More...*
  - - - Use of Status Labels (Equipment and Areas) - More...*
  - - - Packaging Procedures - More...*
  - - - Line Clearance Procedures - More...*
  - - - Staging Procedures (Materials, Components and Labels) - More...*
  - - - Use of Approved Lubricants, Oils and Cleaning Agents - More...*
 
- Clinical * Requires Login
  - - - Serious Adverse Event Reporting (Clinical) - More...*
  - - - Investigator Site Audit and Monitoring (Clinical) - More...*
  - - - Good Clinical Practice Training (Clinical) - More...*
  - - - Clinical Supply Management (Clinical) - More...*
  - - - Clinical Trial Initiation - More...*
  - - - Clinical Trial Closure - More...*
  - - - Set up and Management of a Clinical Trial Database - More...*
  - - - Informed Consent in Clinical Trials - More...*
  - - - Financial Disclosure of Investigators - More...*
  - - - Control of Clinical Trial Drug Supplies (CTM) - More...*
  - - - Investigator Site Selection - More...*
  - - - Labelling of Medical Products for Clinical Trials - More...*
  - - - Collection and Archiving of Clinical Trial Documentation - More...*
  - - - Remote Archiving of Documentation - More...*
  - - - Registration-Inclusion of Subjects in Clinical Trials - More...*
  - - - Ethics Committees - More...*
  - - - Clinical Trial Protocol - More...*
  - - - Clinical Trial Protocol Amendments - More...*
  - - - Case Report Forms for Clinical Trail - More...*
  - - - Final Study Report of a Clinical Trial - More...*
  - - - Trial Master Files (TMFs) - More...*
  - - - Verification of Source Documents - More...*
  - - - Planning and Preparation of Annual Safety Reports - More...*
  - - - Safety Committee and Safety Reports - More...*
  - - - Management of SAEs, AEs, and ARs. - More...*
  - - - Preparation of IND Annual Reports - More...*
  - - - Product Recalls - More...*
  - - - Pharmacy Management - More...*
  - - - Clinical Trial Record Management - More...*
  - - - Clinical Audits and Audit Reports - More...*
  - - - Statistical and Bio-Statistical Operations - More...*
  - - - Clinical Programming Standards - More...*
  - - - Clinical Trials Randomization - More...*
  - - - Personnel Training - Clinical - More...*
  - - - Clinical Research Project Confidentiality Agreement - More...*
  - - - Investigators Brochure - More...*
  - - - Clinical Data Flow - More...*
  - - - Clinical Trial Monitoring - More...*
  - - - Development of Clinical Trial Database - More...*
  - - - Database Audits - More...*
  - - - Database Locks and Unlocking Procedure - More...*
 
 
 

 

 

 


 

 

 


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