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PDS GxP Compliance Suite
Features

Product Detail

The PDS GxP Compliance Documentation Suite, which includes both mandatory (M) and optional (O) elements, is offered at fixed price (under licence). The product consists of a number of layers and activity areas which encompass all appropriate regulatory (GxP) requirements:

  • Corporate IT Policies, Standards and Guidelines templates (M)
  • IT Procedures (SOPs) templates (M)
  • Computer Systems Validation (CSV) Policies, Guidelines & Procedures (O)
  • Software Development Life Cycle (SDLC) Policies, Guidelines and Procedures (O)
  • 3 rd Party Product/Provider Selection/Audit Policies, Guidelines and Procedures (O)

The product components form an integrated matrix with the Optional modules layering onto the Mandatory modules to provide a coherent suite. The purchased elements are customised prior to delivery to incorporate the client's logo and other formatting requirements so as to enable the documentation to dovetail seamlessly into the client's QMS and to be 'owned' by the client.
Structure of Standard Product Deliverables


The standard product is delivered as an integrated suite of documentation, sub-divided into coherent topics/ application areas. The following paragraphs give a top level overview of their contents:
Corporate IT Policies, Standards and Guidelines templates(M)

 

  • Security control
  • Risk management
  • Network management
  • Resource sharing
  • Outsourcing
  • QA management
  • Inventory management
  • 21 CFR Part 11 and GxP
  • Infrastructure qualification
  • Information sharing
  • Application management
  • Compliance assessment


IT Procedures (SOP) templates (M)

 

  • Part 11 and GxP
  • Security management
  • System maintenance
  • Backup/disaster recovery
  • Document management
  • Incident management
  • System decommissioning
  • 3 rd Party products/services
  • E-records management
  • Config/change management
  • Risk management

 

Computer Systems Validation (CSV) Policies, Guidelines & Procedures (O)
    • Validation planning
    • Part 11 and GxP assessment
    • Installation qualification
    • Operational qualification
    • Validation reporting
    • Validation traceability matrix
    • Spreadsheet validation
    • Design qualification
    • Performance qualification
    • Periodic compliance auditing

Software Development Life Cycle (SDLC) Policies, Guidelines & Procedures (O)


  • User requirements
  • Functional/design specs
  • In-process testing
  • System testing
  • Product release
  • Training
  • Change management
  • Product retirement
  • Development standards
  • Acceptance testing
  • Product support

 


3rd Party Product / Provider Selection / Audit Policies, Guidelines & Procedures (O)
  • Product/Supplier selection
  • Request for information
  • Request for proposal
  • Product assessment
  • Service level agreements
  • Supplier auditing
  • Part 11 and CSV training

 

 

Product detail

The PDS GxP Compliance Consulting Service provides specialist services to assist clients in customising the ‘generic’ documentation suite and in performing training activities (such as validating software applications, auditing third party suppliers, etc.). In the first instance, 10 days consulting effort, delivered either consecutively or on a call-off basis, is included in the Mandatory deliverables to help clients to develop a remediation plan, perform initial assessments and undertake immediate remediation activities.

Thereafter, consulting services will be made available ‘as required’ for tasks ranging from project management to technical authoring. These will be chargeable at rates to be agreed.