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Compliance Associates Announces Release of Validation Automation Tool for Process Validation, PV VALIDATOR

July 24, 2015 by
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Company Has Product Offerings for Both Computer System Validation and Process Validation

Toronto, ON –  Understanding and keeping pace with the world of regulatory compliance can be time consuming. Companies need to be able to quickly respond to changes, but this can be hard with the current state of Process Validation. Compliance Associates releases a new product offering that promises to streamline the process – PV Validator for Process Validation Lifecycle Management.

PV Validator is a web-based application that uses principles of Process Validation to establish scientific evidence for consistently manufacturing quality products. The system incorporates instrumental Risk Assessment and Statistical Evaluation tools. Organizations wanting to achieve excellence require a system that will facilitate the creation and management of all inputs and outputs of their processes, a system that will interface with all enterprise systems contributing to said process.

Key Benefits

PV Validator is a step toward improved product development, quality and process management. Companies will be able to respond to rapid changes, shorten time to revenue, and reduce process risks. The system allows for collection and evaluation of data through all stages of Process Validation, thus helping in establishing scientific evidence for consistently manufacturing quality products.

PV Validator facilitates application of Process Validation Guidelines (Ex. FDA, EMA, WHO) and the Quality By Design (QbD) approach. An automated system can greatly streamline the process, saving time and money.

With PV Validator, pharmaceutical companies will be enabled with a tool to gather in-depth understanding of their processes and products (Knowledge Management), perform statistical assessments and trending to ensure product robustness.

Highlights include:

Technical Risk Assessment Tool – based on the interaction of process parameters and quality attributes, a risk management technique is applied to prioritize the critical parameters.

Continued Process Verification – Validator monitors commercial batches for detection of undesired variability for ongoing assurance that the process remains in a state of control. Integration with enterprise systems such as ERP and LIMS allows for linking the batch genealogy information with testing data thus facilitating a holistic product review. It is an effective quality risk management tool for detecting trends and implementing preventive measures prior to encountering a potential failure.

Data Analysis and Trending – Validator imports testing data from LIMS and provides online trending analysis as well as statistical analysis results such as process capability calculations.

Document/Content Management – documents can be created on the fly by dragging and dropping desired content, or created automatically based on predefined templates. The documentation engine takes care of all formatting tasks and boasts a flexible, comprehensive 21 CFR part 11 compliance workflow.

About Compliance Associates
Compliance Associates is your partner for regulatory compliance. With over 25 years of experience, we provide solutions that optimize compliance and regulatory infrastructure. Validator, our industry leading compliance solution, is a true content management system that allows companies to automate the entire lifecycle of validation, for any type of validation project. It’s built specifically for validation and is the only truly automated compliance solution available.

Find out how Compliance Associates and Validator can help your organization today. Email us at info@complianceassociates.ca or call 905-738-3773 to request a product demo or to set up a meeting.

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