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Regulatory Compliant Software Solutions
Within industries such as the pharmaceutical, medical device, and financial services, there is often a requirement to comply with government regulations, or with good practices. For example, many pharmaceutical, biotech and medical device companies need to comply with the FDA regulations known as 21 CFR Parts 11 and 820. Many companies need to comply with the Sarbanes Oxley Act of 2002. When you need to select a solution that complies with ISO, ITIL, GCMP, CMM, 21 CFR Parts 11 and 820, Sarbanes-Oxley or any other regulatations, ExtraView Enterprise has a complete range of features that support your requirements. This includes validation of your system to support IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).
Relevant ExtraView Enterprise Platform Features
| Access Security |
▶Secure password access to sign on; support for LDAP and SSO servers
▶Role-based security allows the definition of an infinite number of user roles, each with its own set of permissions
▶Field-level security permission on all fields - set any field for any role to read/write, read-only, no permission
▶Functional level security on ExtraView features - enable and disable any feature for any role
▶Full log of all system accesses by all users
▶Automatic notification of multiple failed sign on attempts by a user
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| Audit Trail |
▶Every change to every issue record is logged
▶Easy to view and understand history reports that show who made the change, when they made the change, each field item added to an issue, each item changed in an issue and each field deleted from an issue
▶Deleted issues and fields are not really deleted - they still exist in the database for audit purposes, but are not accessible to the end user
▶Full audit trail of changes to all the supporting metadata in your application. For example, easily see who created a new field or who created a new business rule or who updated a workflow
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| Electronic Signatures |
▶Prompt for reauthentication of the user's credentials at any defined points in the workflow
▶Electronic signature may be dependent upon several factors at one time
▶User's name and the current timestamp are associated with the electronic signature
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| Regulatory Reports |
▶For example use decision trees to automatically generate a MedWatch 3500 form, or its equivalent in any country
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| Automatic notification |
▶All stakeholders in an issue are automatically informed of changes in which they may be interested
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Validation Services
Validating a system for the purpose of compliance with regulations is the responsibility of the company using the system. ExtraView Corporation can assist with many parts of the process. In addition, ExtraView Corporation uses an extensive, auditable set of SOP's to produce the ExtraView software, giving you confidence in our ability to produce a highly-reliable, highly stable, quality solution. Our Professional Services group understands your needs and will assist you with all aspects of the IQ, PQ and OQ of your validated system.
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