Frequently Asked Questions (FAQ)

evalii® uses a complex middleware architecture to connect and monitor a wide variety of digital channels. Proprietary, validated algorithms automatically analyze content for PV relevance, legal risks, and moderation requirements – reliably, scalably, and audit-compliant.

Monitoring: evalii® actively monitors your channels (e.g., Facebook, Instagram, Twitter/X, WhatsApp Business API, app stores, HCP portals) for direct posts, comments, ads, and other posts. Listening: evalii® also detects indirect mentions in public sources—including blogs, forums, patient portals, and RSS feeds—for sentiment analysis and early detection.

evalii® scans, among other things: Social Media: Facebook, Instagram, Twitter/X, TikTok, YouTube, Snapchat, LinkedIn, etc. Review and communication channels: WhatsApp, app stores (including Apple App Store, Google Play Store), Google Maps, Amazon, emails, YouTube, and website forms Communities & specialist portals: HCP forums, patient portals, blogs, Reddit, RSS

- Automatic classification, - Escalation according to defined workflows, - Escalation of PV-relevant content within 6 hours, 12 hours or 24 hours, - Moderation according to netiquette

evalii® uses APIs, semantic filters, classifications, moderation protocols and proprietary validation algorithms to detect, analyze and process content.

Monitoring: direct customer channels. Listening: public content from the web – including mentions without direct tags.

Comments, ratings, direct messages, emails, posts, stories, reactions, videos, emojis, file uploads, hashtags, forms and links based on the agreed monitoring and in compliance with data protection regulations.

Yes – evalii® combines automation with manually assisted moderation.

Depending on the content type, this can be done automatically (e.g., PV-relevant) or after manual review. Escalation times can be flexibly configured (e.g., 6 h / 12 h / 24 h).

Yes, if requested – e.g., personal information or health data before forwarding and according to customer specifications, within the scope of processing permitted by data protection law.

All interactions can be archived and exported in an audit-proof manner in accordance with recognized or agreed standards – including a time stamp.

Yes – evalii® supports form fields, contact forms, chat plugins and comment areas, among others.

Yes – evalii® can evaluate content in DocCheck areas, medical discussion forums or CME platforms.

Yes, provided there is an API connection and in compliance with the GDPR – for example, in the context of Comviira projects.

Yes – evalii® is fully integrated into Comviira and automatically monitors relevant statements.

Yes – with evalii® you can apply semantic weightings, even to symbols or sentence fragments.

Yes – e.g. product names, risks, substances, diseases, batch numbers.

Rules can be combined but are subject to regulatory requirements: content + location + platform + language + time + user status.

evalii® detects, documents, and reports PV-relevant content according to internal and regulatory deadlines. The solution relieves the burden on internal PV teams and enables monitoring of even large amounts of data.

Upon request, evalii® will moderate your channels. This includes responding to comments, adhering to netiquette, reviewing legally sensitive content, and automatically initiating escalation.

No. evalii® is a fully managed service and is operated exclusively by the experienced team at Cross4Channel GmbH. This ensures consistently high quality, audit compliance, and regulatory security – without any additional burden on your internal resources.

Yes. evalii® is scalable, stable, and designed for high-volume projects—including international market launches.

evalii® is audited on average in 10 audits per year – by customers, external auditors and internal quality assurance processes.

ISO audits, PV system audits, data protection audits, IT security checks, validation reviews.

With SOPs, validation documents, user manual, training documents, release documentation, audit trail.

Yes – all logs, decisions, changes and exports are documented with a timestamp and user ID in accordance with audit-proof requirements.

Within a few days – including basic configuration, training, QA checks and kickoff.

Yes – including via REST API, email listeners, Jira, CSV, database interfaces or individual workflows.

Yes – different brands, countries or indications can be represented separately with their own teams, rules and approval chains.

In a structured process with initial setup, data source configuration, release check, test run, go-live.

Through a dedicated support team (Mon-Sun), including PV support, emergency contact, weekly status and monthly reporting.

Yes – SOPs and internal processes can be configured directly into the system.

Project-related packages, campaign setups or annual contracts with monitoring flat rate.

Yes – evalii® is successfully used by international pharmaceutical companies in over 20 countries (details upon request and subject to confidentiality).

Yes. evalii® has been successfully audited several times in recent years by international pharmaceutical customers and as part of ISO 9001:2015 audits.

evalii® comprehensively meets the regulatory requirements for use in national, European, and international pharmacovigilance systems. This includes, among others, EU regulations such as Regulation (EC) No. 726/2004, Directive 2001/83/EC, and Implementing Regulation (EU) No. 520/2012. Good Pharmacovigilance Practices (GVP) also apply, as do the German Medicines Act (AMG) and FDA regulations (21 CFR Part 314 & Part 600). International standards such as the ICH Guidelines (e.g., ICH E2E, E2D) have also been considered, ensuring compatibility with international pharmacovigilance guidelines. Data protection requirements according to the GDPR and international information security standards are also implemented.

- ISO 9001:15 (Cross4Channel GmbH), - ISO 27001 (data centers), - Technical and organizational - - measures for data protection security are fully documented.

The data is processed exclusively in German, ISO-certified data centers. Storage is encrypted, role-based, and complies with GxP guidelines.

evalii® is committed to comprehensive compliance with the General Data Protection Regulation (GDPR) and relevant international data protection regulations. The protection of personal data is ensured by a multi-level data protection and IT security concept that includes comprehensive technical and organizational measures (TOM), such as the pseudonymization of personal data, data backup, and access restrictions.

Yes. evalii® provides a data processing agreement (DPA) in accordance with Art. 28 (3) GDPR that meets all legal requirements.

evalii® identifies and classifies PV-relevant content. This is documented in a timely manner, forwarded to the relevant authorities, and archived if necessary.

evalii® scans for suspected side effects, misuse, abuse, medication errors, pregnancy, overdose, interactions or product defects, among other things.

Yes. evalii® takes into account regulatory definitions according to EMA, FDA, and WHO and adapts to customer-specific SOPs.

Yes – e.g.: Info-only → Review by Safety Officer → Immediate report → Documentation subject to audit.

Yes – automated or manual, via interfaces, email, Jira, CSV or your own notification systems.

evalii® has relevance filters, spam detection and manual moderation approval.

No. evalii® allows individual filtering: only PV-relevant, only HCP, only in defined channels.

12 months as standard, longer on request – depending on company and legal requirements.

evalii® records all activities in a history: who viewed, evaluated, released, changed or escalated what and when.

Yes – e.g. as a PDF export, ZIP file or structured JSON download for local systems.

Yes – content, netiquette and response logic can be defined and approved in advance in accordance with the German Medicines Advertising Act.

Yes – evalii® is regularly tested according to pharmaceutical validation guidelines, including GAMP 5.

evalii® provides pharmaceutical-experienced moderators and safety agents, trained in PV criteria and medical/legal requirements.

Yes – evalii® allows the integration of external safety teams or agencies via role-based access concepts.

evalii® is based on EMA guidelines, FDA REMS specifications, GVP modules I–VI, WHO criteria and GDPR/ISO 27001.