Align©
Stiemcorp is proud to announce Align© as its latest validation solution to meet your immediate and future system life cycle compliance needs. This is the cumulative product of the best of the best practices utilizing established and recognized methodologies for computer system validation that will drastically reduce your project timeline and cost without sacrifice to quality or service.
How does it work?
This turn-key solution is a coordination of Stiemcorp project representative(s), you the customer, and a full suite of ready-to-use qualification documents based on proven and defensible Good Automated Manufacturing Practices (GAMP) systems life cycle.
"By using the Align© turn-key solution, the bulk of the work is already completed."
All the document templates have already been created and will be tailored by experienced Stiemcorp Validation Specialists to suit your business and system needs according to the predefined system categories.
The foundation document is the System Life Cycle (SLC). The SLC is your guide to defining the systems that fall under the requirements set forth in domestic and/or international regulations including 21CFR820, 21CFR210/211, 21CFR11 and the phases of the system life cycle.
"It's like working a puzzle - if you've got the box-top picture, you know where each piece you're handed goes. If you don't have the picture, you're handed these pieces and have no idea what you're supposed to make of them."
The System Categorization document details the steps to categorize systems according to current GAMP practices. With this documented information, the SCL describes what documents are required in each phase.
A Stiemcorp representative will work with you to determine the project scope and to determine project timelines and deliverables, review existing documentation to ensure conformance to your policies, determine an overall validation plan and establish system requirements. Based on these requirements, Stiemcorp then creates the required documents either at your site or off-site (further savings). Project communications is maintained according to a pre-established plan to ensure mutual success. Once the documents are completed, you may choose to execute them yourselves or take advantage of our validation specialist to ensure a timely, cost effective, complete validation package.
Included in the Align© package:
- System Life Cycle SOP
- System Categorization SOP
- Validation Plan
- Functional and/or User Requirements Specifications
- Design Specifications
- Configuration Specifications
- Requirements Traceability Matrix
- Risk Assessment and Management
- Design Qualification
- Vendor Assessment and Report
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Data Migration and/or System Retirement
- Validation Summary Report
- Validation Errors, Deviations, and Test Failure Recording SOP
These are all Microsoft Word format documents that you can modify and use for future projects.
"Not only is the package clear and easy to understand but each document is well thought-out, includes every detail and the electronic versions are cleanly built for easy modification for future projects."
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