Compliance is a partnership between your software vender and you. Perform brings features and processes that work for your use within your compliance protocol. Our platform has been designed to conform with 21 CFR Part 11 and reflects other international requirements from the USFDA, EU and other clinical regulatory communities.
Support of FDA and International Clinical Standards
21 CFR Part 11 covers a broad range of compliance requirements for both your software and your organization’s standard operating procedures (SOPS). We have built the Perform platform to include the technical aspects required for FDA compliance and with other national regulatory requirements.
We have considered all regulatory requirements for software development and follow a consistent Software Development Lifecycle (SDLC) which includes requirements documentation, change authorization, version control and issue tracking.
Control of your Clinical Data
As part of our commitment our customers, we provide our clients with the assurance that your data is safe, secure and accessible. Control of your data is protected both while you access it via the web and where your data is stored.
Perform stores and protects all files that have been uploaded to it by using a complex checksum. All files are verified during every access to each document and the user notified if there is an error. All files are backed up through file system replication and automatically restored as needed.
Rest assured that your data is secure when it is hosted with our hosting providers. Data quality and accessibility is protected with redundant backup and power systems, biometric security access and 24x7 surveillance and staffing.
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