SharePoint Validation Management for Pharma
In today’s pharma landscape, an increasing number of computerized systems are being used within the context of regulated activities. Due to the complexity and granularity of the documentation and processes involved, managing the validation of these systems is extremely time consuming and costly. The cost of validation often represents a significant part of a system implementation budget. Montrium through its experience and expertise has deployed a series of forms, document libraries, templates and workflows to facilitate the validation management process. Strong emphasis has been placed on risk management techniques to optimize the validation process.
Validated IT System Inventory
The Validated IT System Inventory enables the IT group to manage and control the validated state of computerized system used for regulated activities. The inventory consists of hardware and software components as well as sub-systems which can be linked in a hierarchical manner to form the complete system architecture for each validated system. The Validated IT System Reports allows us to view all documentation, including validation documents, executed test scripts, non-conformance reports and change controls related to each system.
Validation Document Library and Templates
The Validation Document Library is used to store both source and executed validation documents. This library comes with a complete set of MS Word document templates based on the GAMP5 standards. These document templates include:
- Validation Assessment
- Validation Plan
- Requirements
- Requirements Traceability Matrix
- Risk Assessment
- Functional Specifications
- Design Specifications
- Configuration Specifications
- System Specifications
- Test Protocol
- Test Script
- Test Report
- Migration Plan
- Training Plan
- Validation Summary Report
These templates are in line with Montrium’s CSV SOP, however can be adapted to your own CSV environment. Workflows manage the review and approval lifecycle of the above documents. Benefits include:
- Standardized templates, document types and metadata ensure that all validation documentation is created and managed in a uniform manner
- Integrates with system inventory and change control modules
- Workflows streamline the review and approval process both pre and post execution
- Ability to maintain libraries of standard requirements and test scirpts
- Ability to generate PDF records of validation documents which can be electronically signed
- Management of document lifecycle status provides realtime view on validation deliverables advancement and state
- Facilitates traceability of all validation deliverables
IT Change Control
IT Change Control enables the management of changes to validated computer systems. Hardware and software inventory lists as well as CSV documents can be referenced in the IT change control form. The IT change control workflow automates the definition, execution and close out of the IT change control request. Benefits include:
- Each stage of the change control process is managed by an automated workflow
- Intelligent InfoPath change control form integrates with system inventory and existing validation documentation
- Multiple change control actions can be allocated as tasks to individuals or groups
- Allows the referencing of test scripts for retest
- Capable of generating PDF based change control records for long-term retention
- Change control dashboard gives real-time overview of change control activities and trends
Configuration Control
Configuration Control is composed of a Form Library and a workflow which manages the process of initiating and approving a configuration change request, as well as the implementation and verification of the configuration change. The configuration control process can be adapted based on the complexity and type of configuration that is needed for each system. Once the configuration request is approved, the configuration control workflow assigns tasks to the individual(s) or group responsible for implementing the configuration change and for updating the corresponding configuration documentation to reflect the change. Benefits Include:
- SharePoint™ specific configuration control workbooks and process which allows the maintainance of validated SharePoint environments
- Integrates with change control form and workflow
- Facilitates the review and approval of configuration changes
- Ability to manage configuration specifications for other validated systems
Non-Conformance Management
The Non-Conformance form & workflow manages the process of reporting non-conformances encountered during validation, through to the analysis of the root cause, the proposal of corrective actions, approval to execute corrective actions and final report close-out. The Non-Conformance Library contains the forms which can be filled directly online via web based form or offline within InfoPath. Benefits include:
- Integration with the test execution process
- Intelligent InfoPath NCR form integrates with system inventory and executed test scripts
- Allows a realtime view of non-conformance summary for a particular system
- Trends and causes can be analyzed within or accross systems to gain better understanding of root causes
- Workflow driven reporting, analysis and close-out accelrates the completion of validaton efforts
Validation Dashboard and Reporting
Montrium has developed a reporting dashboard for each module which is composed of a series of tables, graphs, relevant documents/tasks and key performance indicators (KPIs). This dashboard is deployed within SharePoint™ and provides real-time information on system validation operations. This dashboard can also be used to drill down into data through reporting. Sponsor specific reports and KPIs can also be configured upon request.
