Document Writing
ESOPTRON can provide support with QMS planning, development and implementation. We can also provide support with the implementation or elaboration of specific elements of the QMS such as Supplier management, Quality Risk Management, Change Management and Biosafety Management to name a few.
We will help you to design the quality management process. Our consultants will then prepare a QMS Design report that presents you with a QMS framework and work plan.
To implement the quality management system in a logical and easy way we create document packs that include Manuals, SOPs, protocol forms, report forms, etc. These packs will provide a stepwise plan and resources to guide pharmaceutical companies and medical laboratories towards implementing a quality management system.
Where there is QMS documentation already available our philosophy is to update it where needed and develop new documents to fill the gaps.
| Course | Format |
|---|---|
|
EDP001 |
Quality Policy Personnel Job Description Personnel Position Description New Employee Recruitment and Orientation SOPs Personnel Management and Assessment Tools |
|
EDP002 |
Quality Manual Equipment Quality Manual BioSafety Manual Environment Monitoring Program: Purpose, Protocols and Templates |
|
EDP003 |
Microbiological Method SOPs Microbiological Method Validation SOPs, Microbiological Method Validation Report Template |
|
EDP004 |
Equipment Performance and Maintenance SOPs Equipment Validation / Verification Program, Reports: IQ, OQ, PQ |
|
EDP005 |
Hygiene Rules and Handwashing SOPs Gowning SOP Clean Room Behaviour and Gowning SOPs Cleaning and Disinfection Program |
|
EDP006
|
Quality Risk Assessment Program, SOP, Report Template Aseptic Processing Quality Risk Assessment Aseptic Processing: Media Fill Test Program, Report Template |
|
EDP007
|
Plant Equipment CIP Program, Report Template
|
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