© 2017 Validation Systems

Validation & Technical Services

VSI is comprised of highly motivated validation professionals with a strong work ethic and a wide range of capabilities and experience. Our field intensive nature ensures that your company will receive the necessary level of technical support required to meet your validation needs.

We have a wide array of calibrated test equipment available for use to support our projects.  This allows us a great deal of flexibility in the type of testing we can support.  VSI personnel are trained in the use of our test equipment and are able incorporate this technical knowledge into the development of written qualification protocols to ensure efficient testing objectives and results.

The VSI team of validation professionals have the strong technical writing skills necessary to ensure that the documents we produce are of the highest quality.  We realize that well written documents are both technically correct and accurately written.

 

Our validation and technical services groups provide the following contract services:

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  • Project Management, Project Plans, Project Gantt Charts

  • Design Review

  • Validation Master Plans/Risk-based Strategies

  • Construction Qualification

  • Facility Utility System and Equipment Validation

  • Standard Operating Procedures (SOPs) and Preventative Maintenance Procedures (PM) Writing

  • Computer-Related System Validation

  • QC Analytical Equipment Validation

  • Process and Cleaning Validation

  • Risk Assessment and Impact Assessments

  • Mitigation Solutions

  • User Requirements, Functional, Design, and Configuration Specifications

  • Trace Matrix

Project Management and Project Plans

Meeting project timeline milestones and controlling expenditures are the result of good project management and insightful project planning.  VSI project managers utilize a wide array of scheduling, tracking, and reporting tools to achieve these goals.  Project updates, close-client contact, daily communication, and project team integration are all important elements of VSI’s project management approach.

 

We integrate these virtues into the management of all validation projects is large and small.  We realize that understanding dynamic events throughout the course of a project is a key factor for our clients for them to achieve their corporate and departmental goals.  We believe that open communication with clients is crucial to overall project success.

Design Review

To achieve a smooth validation process, the concepts of validation must be incorporated during the design phase.  Our experience in the biotech, pharmaceutical, and medical device industries allows us to provide broad reviews encompassing not only validation concerns, but also long-term control, current technology, cost/benefits, ease of maintenance, and the ability to meet regulatory requirements while meeting the needs of our clients.

 

VSI can participate in the design review process for your project to ensure your validation effort will be efficient and easily achieved by identifying quality compliant criteria early in the development of facilities, manufacturing systems and processes.

Validation Master Plans/Risk-based Strategies

A Validation Master Plan (VMP) properly defines the project scope by outlining the tasks required to complete the validation process. A VMP will also establish the degree of qualification for each system/piece of equipment.  The VMP is an important tool in assigning project responsibilities, determining resource needs, precedent tasks, establishing objectives and acceptance criteria.

 

VSI provides customized VMP’s that specifically address the individual needs of each client.  Our broad based technical knowledge and expertise in the field of validation allow us to create comprehensive Validation Master Plans that become an essential management tool throughout the validation life cycle.

Construction Qualification

Construction Qualification documentation that is thorough and well organized provides a confidence level that a facility will meet the intended design, but also provides the foundation for the succeeding Installation Qualification.  We recognize the importance of communicating the documentation needs for a GMP facility construction that will be required to successfully validate a facility.

 

VSI provides on-site specialists to audit the construction site, gather and organize documents related to construction and startup and act as an owner liaison with the general contractor, mechanical contractors, and startup services.  In addition, VSI acts as an independent third party to ensure construction and installations are performed according to contractual terms and specifications.

Computer and Automation System Qualification

Since the adoption of the risk-based approach to systems qualification, a 2002 FDA initiative also known as Pharmaceutical cGMPs for the 21st Century: A Risk-based Approach, VSI continually remains in the forefront of applying emerging strategies and observing conforming guidance documents such as GAMP 5, Good Automated Manufacturing Practice version 5. With the emersion of GMP manufacturing systems qualifications into the risk-based concepts, VSI routinely sculpts customized documentation in line with the industry accepted the SDLC life-cycle (System Development Life-cycle) process.  Working with clients, suppliers and system integrators, VSI is proficient at producing specifications for user-requirements, functional, design, and configuration of systems satisfying the developmental stages of the SDLC.  This early involvement paves the way to the efficient generation of qualification protocols and most precisely addresses the needs of the end-user’s needs for the computer automated system while fulfilling quality compliance expectations.  The qualification process is assured of comprehensiveness with the application of a trace-matrix throughout the life-cycle process.