Auditability in Regulated Environments
An audit is to a regulated company what a medical examination is to a patient. It is a necessary procedure for evaluating a system's general “health” and for “diagnosing” problems in order to correct them. In the FDA environment, audits are required to ensure the maintenance and improvement of product quality and safety — and to ensure compliance.
How can InfoStrength Smart Enterprise Suite Benefit You?
The InfoStrength Smart Enterprise Suite solution can help you attain and maintain compliance by automating, streamlining and effectively managing the audit process. Here's how InfoStrength addresses some of the major challenges of both performance and compliance audits.
Features
Infostrength Smart Enterprise Suite is a complete and robust solution that integrates the different steps (preparation, scheduling, execution, findings, verification, and completion) necessary for a successful audit. Infostrength Smart Enterprise Suite is 100 percent web-based so auditors and other users can access it from virtually anywhere. Here are some of its powerful features:
Audit Report – InfoStrength Smart Enterprise Suite provides six important areas to help collect and track data throughout the audit process, as well as streamline the workflow to promote efficiency. And Audit Reports can be reconfigured quickly to meet the auditors specific needs right there on the spot through an easy to use reporting engine.
- Type of Change – Identifies whether a document was created, modified, or deleted.
- Changes Made - Captures the changes made to the document (i.e. uploaded a new version, changed title, changed permissions, etc.)
- Changed by – Keeps track of who made the modification
- Changed on – Records the date, time and second the change was made.
- Reason For Change – Every time the document is modified a reason has to be given by the person modifying the document.
- All audit reports can be printed, saved or exported in Excel, XML or tab Delimited formats.
How InfoStrength Smart Enterprise Suite can Benefit You
- Balancing the need to comply with FDA 21 CFR Part 11 regulations with the need to speed the commercialization process.
- Enabling faster time to market through improved regulatory submission assembly, review and approval processes.
- Providing advanced workflow and collaboration for regulated data, documents, and images.
- Supporting faster, more effective control over content that is critical to your business.
- Reducing IT cost with a more flexible, easier to configure system and with validation test scripts designed to enable rapid implementation.
With proven technologies, knowledge of regulatory compliance processes and systems and strong investment in life sciences, InfoStrength Smart Enterprise Suite offers a unique solution to facilitate regulatory compliance.