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 |
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| Other Templates: |
| - - Audit Reports - Template 1 - Template 2 - Template 3 - Template 4 - More...* |
- - Validation Protocols (Equipment, Methods, Facilities, Process, Cleaning)
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| - - 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 |
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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...* |
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| - 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...* |
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| - 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...* |
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| - 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...* |
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| - 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...* |
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| - 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...* |
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| - 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...* |
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| - 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...* |
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| - 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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