• Is it an internet/web-based application?

        Sarjen’s PvNET is totally a web-based application.

        What Backend component is used?

        MS SQL Server 2008 R2/2012.

        Has the company been audited for software compliance from regulatory authorities?

        Our Clients using Sarjen’s PvNET have been audited multiple times by various Regulatory Agencies (MHRA, FDA, Health Canada, AIFA, FAGG), where Sarjen’s PvNET was found to be compliant with all regulatory mandates.

        What support is available for maintenance, update and backup of database in case of in-house installation?

        · Annual Maintenance (AM) provided by Sarjen
        · Regulatory updates to the database as a part of annual maintenance
        · Back up as per clients internal procedures (Sarjen can assist in developing such procedures)

        Does the database ensure the security and integrity of the system and data?

        The database has in-built procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records, with secure, computer-generated, time-stamped audit trails with authority checks for system access and operations, in accordance with 21CFR part 11.

        Does the database ensure security level in terms of providing access to other affiliates?

        Sarjen’s PvNET allows creation of groups (both client specific & role specific) where access to specific dataset or operations can be provided or restricted.

        Does the system maintain an audit trail/automated log of user transaction?

        Computer-generated, time-stamped audit trails to record the date and time of operator entries and actions are maintained in the database.

        Is there any requirement of any third party software to implement/maintain the interface?

        No third party software is required. It is a single platform comprehensive risk management solution.

        Does the database help in the generation of Regulatory compliant reports ?

        The database generates Line Listings as per CIOMS II for a specified period for a specific drug. It also generates Summary Tabulations for a specific period.
        It also generates listings and tabulations as per US PADER requirements (21 CFR 314.80). All reports are exportable to Excel. All system generated reports will have a report run date and time.

        Does the database provide rules-based report routing?

        · For internal flow of safety information, rule based Workflow is integrated into the database
        · For regulatory or third party exchange, auto-scheduling of reports based on in-built submission rules.
        In addition to in-built reporting rules, new rules can be configured into the database meeting client specific requirements.

        Does the database provide the ability to generate historical reports with ease?

        It allows generation of period specific customised Line Listings.

        Is it possible to perform a duplicate search based on different criteria?

        Duplicate search is possible based on multiple parameters like client, drug, patient age, sex, pregnancy status, outcome, ADR etc.

        Does the database assist novice users of the application?

        Each field of case processing, is supported by Field set reference guide with inbuilt instructions, definitions and regulatory requirements. It also facilitates the generation of user-specific guidelines.

        Does the company provide database training sessions to the end-users?

        Training will be provided at times of deployment and will be chargeable on time cost. We also provide detailed user manuals as a ready reference guide for end-users.

        What are the plans for validation and updates?

        The system is validated once a year and all regulatory updates will be configured into the database.

        Does it allow the user to identify possible signals?

        Uses data mining tool of 2×2 contingency tables to calculate PRRs and SDRs, along with Chi Square and CIs to identify possible signals.

        What are the available reporting formats?

        Options for regulatory reports in formats like Medwatch, CIOMS I form and E2B XML are available.

        Can it be customised to satisfy client requirements?

        Yes, it is always customisable in accordance with the Regulatory guidelines.

        Will there be additional charges for customisation?

        Yes customisation charges will be additional.