Validation Services
The cost and time associated with validation of GxP systems represent a significant part of the overall systems implementation budget. Regulatory agencies have recognized this and now recommend that a risk based approach be used to focus validation efforts on high risk areas and reduce the validation burden whilst improving quality. This approach is at the core of Montrium’s validation service offering.
Montrium’s team of experienced validation specialists can help implement a computer systems validation framework through the use of our internally developed SharePoint Validation Management Workspace. Our validation service offering is based on industry standards and regulations such as GAMP, cGMPs, GCP, 21 CFR Part 11 and Annex 11. Our experience includes validation of various GxP systems as listed under Systems Experience.
Validation Approach
Montrium’s has developed a validation process and a series document templates in-line with GAMP 5 - A Risked Based Approach to Compliant GxP Systems. We work closely with our client’s internal QA and IT team’s as well as software vendors to ensure that a coherent validation strategy is implemented in line with quality requirements, available resources and associated risks with the system.
Through the use of controlled documentation processes and collaboration tools within our SharePoint Validation Management workspace, our validation team is better able to maintain traceability and control throughout each phase of the Computer System Life Cycle, which include:
- planning
- specification, configuration, and development
- verification
- reporting and release
Standard Validation Documentation
CSV and IT SOPs
As you implement validated systems, it is imperative to ensure adequate SOPs are in place in order to maintain control and compliance with regulations, while also protecting your investment in the technology. If your organization does not have SOPs in place to govern validated systems, Montrium is able to provide a standard set of CSV SOPs, which are aligned with industry standards and regulations. These SOPs can serve as base line for your company’s IT related quality system documents, which include the following:
- Computer System Validation
- Hardware Qualification
- IT Change Control
- IT System Maintenance
- IT Contingency Plan
- Physical Security
- Logical Security
- Archiving and System Decommissioning
- Data Backup & Restoration
- Electronic signature Policy / SOP
Montrium is also able to work with your IT and QA groups to adapt these SOPs to your environment. Please contact us if you would like to receive a sample of our SOPs.
Templates
In order to reduce the effort and time required to produce validation documentation, Montrium has developed the following set of document templates, which can serve as the foundation the various deliverables produced throughout the validation effort:
- Validation Plan
- User Requirement Specifications (URS)
- Risk Assessments
- Validation Protocols (IQ, OQ & PQ)
- Test Scripts
- Test Reports
- Traceability Matrix
- Validation Summary Reports
Montrium is also able to work with your IT and QA groups to adapt these templates to your environment. Please contact us if you would like to receive a sample of our templates.
Requirements & Test Scripts
Montrium has recognized the fact that many types of systems have common requirements. Montrium has built packages of standard user requirements and corresponding test scripts for areas such as: System Security, Electronic Signatures, Part 11 Compliant Audit Trails, User Administration. In addition, we also have standard sets of requirements for systems including CTMS, EDC, EDMS, eCTD, Safety, etc. The goal of using these baseline requirements and test scripts is to accelerate the requirements gathering and validation process.
Please contact us if you would like to receive a sample of these documents.
Validation Packages
Montrium also works closely with its partners to produce standard validation packages, which include the full set of validation deliverables. These validation packages can be purchased with or without validation services. These validation packages include:
- SharePoint for regulated environments
- Livelink for regulated documents
- ARX Co-Sign Digital Signatures
- Adlib Express Server
If your organization is interested in developing a standard validation package for your software, feel free to contact us.
