Consulting and validation services for Pharma, Biotech and MedTech.
Nine service areas, one consistent method. Choose the entry point that matches your current decision — or talk to us if the boundary is still unclear.
What is Computer System Validation?
Computer System Validation (CSV) is the documented evidence that a GxP-relevant computerised system is fit for its intended use and operated reliably, securely and traceably.
Regulatory framework: EU GMP Annex 11 requires validated applications and qualified IT infrastructure; 21 CFR Part 11 governs electronic records and signatures in the FDA space.
Methodological framework: GAMP 5 Second Edition (ISPE, 2022) is the recognised good-practice guide for risk-based validation — testing effort follows the real patient, product and data risk.
The result is audit-proof documentation as the basis for a sound release decision.
Evidenced across 17+ years of GxP practice: 60+ validated systems, 100% audit pass rate, 0 critical findings.
AI SERVICE ROUTING
AI consulting or AI validation?
AI consulting is the right route when use cases, governance, policies, provider selection, technical setup or adoption still need to be decided. AI system validation starts once a specific system and GxP intended use are defined and evidence for testing, release and controlled operation is required.
CSV (Computer System Validation) is the broader evidence that a GxP-relevant system is fit for its intended use. Computer Software Assurance (CSA) is the FDA risk-based approach for software used in medical-device production or the quality management system. The revised final guidance issued in February 2026 supersedes the September 2025 version and aligns it with the amended 21 CFR Part 820 Quality Management System Regulation (QMSR). It focuses on intended use, process risk, appropriate assurance activities and objective evidence. For other pharmaceutical GxP contexts, CSA is not a directly applicable FDA requirement, but its methods can be connected with GAMP 5 and risk-based CSV.
Which regulations and standards apply to computer system validation?
The governing regulations are EU GMP Annex 11 (EU) and 21 CFR Part 11 (FDA, electronic records and signatures). The methodological framework is the GAMP 5 guide (ISPE, Second Edition 2022) — a recognised good-practice standard, not a legal norm. ALCOA+ applies for data integrity and ICH Q9 for risk management. Which requirement applies in detail depends on the target market and the system's GxP context.
When does a computer system need to be validated?
GxP-relevant systems require validation — those affecting product quality, patient safety, efficacy or data integrity. The evidence must be in place before release for GxP use. Changes are assessed via change control; affected functions, interfaces and controls are re-verified or revalidated on a risk basis. Whether a system is GxP-relevant is determined by a structured risk and criticality assessment at project start.
How long does a system validation take?
It depends on risk and system complexity. A low-risk standard system is validated in a few weeks; a bespoke, highly critical application takes several months. The risk-based approach per GAMP 5 reduces effort precisely where risk is low — without any compliance gap.
What should pharma companies look for when choosing a CSV consultant?
On three things: demonstrable regulatory experience, a risk-based rather than schematic approach, and continuity in the team. Daniel Herrmann Consulting brings 17+ years of GxP practice and 60+ validated systems, works risk-based per GAMP 5, and integrates into your team — the consultants from the first conversation run the engagement. Results before method: audit-proof validation without unnecessary documentation burden.
VAT identification number pursuant to § 27a German VAT Act (UStG): DE328451232
Consumer dispute resolution (VSBG)
In accordance with § 36 VSBG: we are neither willing nor obliged to participate in dispute resolution proceedings before a consumer arbitration board.
Liability for content
We are responsible for our own content on these pages under the general laws. Under Articles 4 to 8 of Regulation (EU) 2022/2065 (Digital Services Act, DSA), as a service provider we are not obliged to monitor transmitted or stored third-party information or to investigate circumstances that indicate unlawful activity.
Note: The §§ 7–10 of the previous Telemedia Act (TMG) on the liability for digital services have not been transferred to the German Digital Services Act (DDG). Liability for digital services is now primarily regulated by Regulation (EU) 2022/2065 (DSA), in particular Articles 4–8 — referenced above. The §§ 7–10 DDG cover other subjects (limited responsibility under DSA Articles 4–8 + Wi-Fi access, blocking claims under copyright law, lists of audiovisual-media-service and video-sharing-platform providers, and information-request rights of the competent authorities under state law).
Copyright
The content and works on these pages created by the site operator are subject to German copyright law. Reproduction, processing, distribution and any kind of exploitation outside the limits of copyright require the written consent of the respective author.
Privacy Policy
1. At a glance
The following information gives a simple overview of what happens to your personal data when you visit this website. Personal data is any data that can be used to identify you personally.
2. Controller
The controller responsible for data processing on this website pursuant to Art. 4 (7) GDPR is:
Daniel Herrmann Consulting Daniel Herrmann (sole proprietor) Enzweilerweg 3a · 66709 Weiskirchen · Germany Phone: +49 170 7878065 Email: info@daniel-herrmann.io
A data protection officer has not been appointed; the controller is your point of contact for all data protection matters.
3. Server logs
When you visit this website, the hosting provider automatically collects technical information in server log files: IP address (anonymised after 7 days), date and time of access, page accessed, referrer, user agent. Legal basis: Art. 6 (1) (f) GDPR — legitimate interest in technically reliable operation. Retention: 7 days, then automatic deletion. No merger with other data sources.
4. Contact
If you contact us via form, email or phone, we store the information you provide (name, email, company, message content) to process the enquiry and for follow-up questions. Legal basis: Art. 6 (1) (b) GDPR (pre-contractual measures) and Art. 6 (1) (f) GDPR (legitimate interest in answering enquiries). Retention: deletion as soon as the enquiry has been finally processed, at the latest after 12 months, unless statutory retention obligations apply. Data is not shared with third parties.
5. Lead magnets (PDF downloads)
To request our practical guides (e.g. Strategy Guide, Compliance-Gap Analysis, Execution Playbook) we ask for your email address and, optionally, your name and company. The data is stored solely to provide the requested material and for documentation of consent. Legal basis: Art. 6 (1) (a) GDPR (consent). Retention: until your withdrawal, at most 24 months. The newsletter subscription is offered as a separate, opt-in checkbox on the lead-magnet form (no coupling — you can request the material without subscribing). No marketing emails are sent without separate consent.
5a. Newsletter (Double-Opt-In)
If you sign up for our newsletter, we use the double-opt-in procedure: after entering your email and name you receive a confirmation email with a verification link. Only after you click the link do we activate the subscription and document your consent. Data: email, name, consent timestamp, confirmation IP. Purpose: sending the monthly dhc newsletter with practice insights, plus documentation of the consent process (Art. 7 (1) GDPR). Legal basis: Art. 6 (1) (a) GDPR (consent), § 7 (2) Nr. 3 UWG. Retention: for as long as your subscription is active; consent logs retained for 3 years after the end of the subscription as evidence in the event of complaints. Withdrawal: every newsletter contains a one-click unsubscribe link in the footer. Alternatively a short email to info@daniel-herrmann.io is sufficient. Processor: the newsletter is sent via our hosting provider's SMTP infrastructure; we currently do not use a third-party email-marketing tool. As soon as we transition to a dedicated newsletter-tool (e.g. Brevo), we will update this section and conclude an additional data-processing agreement.
5c. Link-click tracking in our emails
To understand which content in our lead-magnet emails and newsletter issues is actually useful, we route outbound links through an internal redirect endpoint (`/t/`). Each link in each send gets an aggregate click counter — but we do NOT store an identifier of the individual recipient, NO IP address and NO user agent. The data we keep is comparable to anonymous server logs (e.g.: ‘link X in send Y was clicked 42 times in total’). It does not allow us to infer who clicked. Therefore no separate consent or cookie banner is required (recital 26 GDPR — anonymous data, no personal-data processing per Art. 4 (1) GDPR). Legal basis for the redirect itself: Art. 6 (1) (f) GDPR (legitimate interest in measuring content effectiveness for our own communications). Legal pages (Impressum, Datenschutz) and the unsubscribe link are NEVER routed through the redirect, so the click behaviour on legally relevant links is never measured.
5b. Retention overview & justifications
A consolidated view of all retention periods with the rationale behind each one — the principle: minimal storage, clear purpose, documented basis.
Data categoryRetentionJustification
Server logs7 daysSufficient for technical fault analysis & security forensics — Art. 6 (1) (f) GDPR. IP anonymisation kicks in immediately on log close.
Contact enquiries12 monthsB2B sales cycle in pharma typically runs 6–9 months. 12 months covers follow-ups without unnecessary stockpiling. Statutory retention (e.g. § 257 HGB) only applies once a contract is concluded.
Lead magnetsup to 24 monthsUntil withdrawal of consent; 24-month cap covers documentation of consent (Art. 7 GDPR) and re-engagement cycle. Withdrawal at any time, deletion within 7 days of request.
Newsletter subscriptionactive subscription + 3 yrs consent logEmail + name only as long as the subscription is active. Consent log (timestamp + IP) retained 3 years to cover statutory limitation period (§ 195 BGB) for complaints under § 7 UWG.
Cookies (incl. analytics)30 min – 14 monthsPer-tool detailed in 6.9. GA4 capped at 14 months (the GA4 minimum, shorter possible only via property reset); all other tools below or equal to industry standard.
Cookiebot consent12 monthsMaximum window the EDPB considers reasonable for repeat-consent requests. After 12 months a fresh banner appears.
6. Cookies, analytics & tracking
This website uses analytics and tracking tools that go beyond pure reach measurement and create usage profiles. Personal data may be processed (in particular IP address, device and browser information, behaviour data) and transferred to third countries (including the USA). Legal basis is your consent pursuant to § 25 (1) TTDSG and Art. 6 (1) (a) GDPR. The consent is granted on first visit via our cookie banner and can be withdrawn at any time with effect for the future — see section 6.10 below. Withdrawal is as simple as granting consent (Art. 7 (3) GDPR); the lawfulness of processing carried out on the basis of consent prior to withdrawal remains unaffected.
6.0 Consent management (Cookiebot)
Provider: Cybot A/S, Havnegade 39, 1058 Copenhagen, Denmark (a Usercentrics company) — EU-based. Purpose: Cookiebot is the consent management platform (CMP) we use to document your consent in line with § 25 TTDSG and Art. 7 GDPR and to block analytics / tracking tools until you opt in. Data: Cookiebot stores a ‘CookieConsent’ cookie containing your consent state (categories, timestamp, anonymous identifier) and a server-side consent log. Retention: up to 12 months from the moment consent is given; renewed on each new visit after expiry. Legal basis: the processing of consent itself rests on Art. 6 (1) (c) GDPR (legal obligation to document consent). Third-country transfer: primary processing in the EU; sub-processors may include service providers outside the EEA under EU Standard Contractual Clauses. Data processing agreement: concluded with Cybot A/S. More info:Cookiebot Privacy Policy.
6.1 Google Analytics 4
Provider: Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland (parent company: Google LLC, USA). Purpose: Tracking tool that goes beyond pure reach measurement. Google uses the collected data for the operation of GA4 and partly for its own purposes (no commissioned processing in the narrow sense for these purposes). Data: pseudonymous identifiers (client ID), IP address (shortened on EU server, see below), page views, dwell time, scroll depth, click events, device and browser information, approximate location (country / region from IP). Retention: up to 14 months for event-level data, then automatic deletion. IP shortening: The IP address is shortened on an EU server before being forwarded to the USA (‘_anonymizeIp’ equivalent in GA4 is active by default). Third-country transfer: data is processed on servers in the USA. Safeguards: EU Standard Contractual Clauses and the EU-US Data Privacy Framework (Adequacy Decision of 10 July 2023). Note that the supervisory authorities point out that the legal certainty gained may only be temporary; previous adequacy regimes (Safe Harbor, Privacy Shield) were invalidated by the CJEU. Data processing agreement: concluded with Google Ireland Ltd. More info:Google Privacy Policy, Browser opt-out.
6.2 Microsoft Clarity
Provider: Microsoft Ireland Operations Ltd., One Microsoft Place, South County Business Park, Leopardstown, Dublin 18, Ireland (parent: Microsoft Corporation, USA). Purpose: Session recordings and heatmaps to improve usability. Note: session recordings are a particularly intensive form of processing — they can capture sensitive content even though input fields are masked by default. We have configured the strictest masking level (‘Strict’) for all form fields. Data: mouse movements, clicks, scroll behaviour, page views, device and browser information, shortened IP address, country. Retention: up to 12 months from the last recorded session. Third-country transfer: Microsoft is a US group; data may be processed on servers in the USA. Safeguards: EU Standard Contractual Clauses and the EU-US Data Privacy Framework. The reservations noted above for GA4 apply analogously. Data processing agreement: Microsoft Online Services DPA concluded. More info:Microsoft Privacy Statement.
6.3 Leadfeeder (Dealfront)
Provider: Dealfront Germany GmbH (Leadfeeder), Markgrafenstraße 36, 10117 Berlin, Germany — EU-based provider. Purpose: B2B identification of visiting companies based on commercially licensed IP-address databases (e.g. RIPE, ARIN, public corporate IP ranges). We use this to inform our sales outreach. The aim is identification of the company, not of an individual user. Important note from a data protection perspective: IP addresses can constitute personal data, particularly when combined with other data. We therefore treat Leadfeeder processing as relevant under GDPR. Data: IP address, page views, timestamp, dwell time, referrer. Data sources: Dealfront enriches IP data with publicly available company information and licensed B2B databases. Retention: up to 12 months on visit level; aggregated reports may be retained longer. Third-country transfer: Dealfront operates primarily on EU infrastructure; sub-processors may include US service providers under EU Standard Contractual Clauses. Data processing agreement: concluded with Dealfront Germany GmbH. More info:Dealfront Privacy Policy.
6.4 Google Ads
Provider: Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland (parent: Google LLC, USA). Purpose: We use Google Ads conversion tracking and (where activated) remarketing to measure the success of advertising campaigns and to address visitors with relevant ads. Data: pseudonymous click ID (gclid), conversion event, conversion timestamp, device and browser information. Cookies used include `_gcl_au` (conversion linker) and `test_cookie` (doubleclick.net technical test cookie). Retention: `_gcl_au` up to 90 days, conversion logs in the Google Ads account according to Google retention settings. Third-country transfer: data is processed on Google servers including the USA. Safeguards: EU Standard Contractual Clauses and the EU-US Data Privacy Framework. Data processing agreement: concluded with Google Ireland Ltd. More info:Google Privacy Policy, Ad personalisation settings.
6.5 LinkedIn Insight Tag
Provider: LinkedIn Ireland Unlimited Company, Wilton Plaza, Wilton Place, Dublin 2, Ireland (parent: LinkedIn Corporation, USA). Purpose: The LinkedIn Insight Tag enables campaign measurement, audience analytics and (where activated) retargeting for LinkedIn ad campaigns. Data: IP address (truncated), timestamp, page URL, device characteristics, LinkedIn member ID where the visitor has been logged in to LinkedIn. Cookies used include `bcookie`, `lidc`, `bscookie`. Retention: up to 6 months for direct identifiers; aggregated campaign reports may be retained longer. Third-country transfer: data is processed on LinkedIn servers including the USA. Safeguards: EU Standard Contractual Clauses and the EU-US Data Privacy Framework. Data processing agreement: concluded with LinkedIn Ireland Unlimited Company. More info:LinkedIn Privacy Policy, LinkedIn opt-out.
6.5a Meta Pixel (Facebook Pixel)
Provider: Meta Platforms Ireland Ltd., Merrion Road, Dublin 4, D04 X2K5, Ireland (parent: Meta Platforms, Inc., 1601 Willow Road, Menlo Park, CA 94025, USA). Purpose: The Meta Pixel (also ‘Facebook Pixel’) enables reach measurement, conversion tracking and (where activated) retargeting for advertising campaigns on Facebook and Instagram. It lets us measure the effectiveness of our ads and show relevant advertising to visitors. Data: pseudonymous identifiers, IP address, device and browser information, referrer URL, triggered events (e.g. page view). Cookies used include `_fbp` (first-party cookie used to recognise the browser) and `_fbc` (click identifier derived from the `fbclid` URL parameter). If the visitor was logged in to Facebook / Instagram at the time of the visit, Meta can attribute the visit to the respective account. Joint controllership: for the collection and transmission of the data to Meta there is joint controllership within the meaning of Art. 26 GDPR between us and Meta; we have concluded Meta’s controller addendum for this. Meta is solely responsible for any subsequent processing of the data for its own purposes. Retention: `_fbp` up to 90 days; on the event level according to the retention settings in the Meta Events Manager. Third-country transfer: data is processed on Meta servers including the USA. Safeguards: EU Standard Contractual Clauses and the EU-US Data Privacy Framework (Adequacy Decision of 10 July 2023). The reservations noted above for GA4 apply analogously. Legal basis: your consent pursuant to § 25 (1) TTDSG and Art. 6 (1) (a) GDPR. The pixel is only loaded after you have given consent via our Cookiebot banner. More info:Meta Privacy Policy, Meta ad settings.
6.6 Google Tag Manager
Provider: Google Ireland Limited (see 6.1). Purpose: Google Tag Manager (GTM) is a tag-management system that loads other tracking tags (e.g. Google Analytics, Google Ads, LinkedIn Insight Tag) on this website. GTM itself does not set any cookies and does not collect personal data per se; it only orchestrates the tags loaded after consent. Data: technical request data (IP address, timestamp, user agent) is briefly seen by Google’s GTM-loader server. No persistent identifier is set by GTM itself. Third-country transfer: the GTM loader is hosted on Google infrastructure including the USA. Safeguards as in 6.1. Note: we have configured GTM so that no measurement tag fires before you have given consent via our Cookiebot banner. More info:Google Privacy Policy.
6.7 Cloudflare (CDN & bot management)
Provider: Cloudflare, Inc., 101 Townsend Street, San Francisco, CA 94107, USA, with EU representative Cloudflare Germany GmbH, Rosental 7, c/o Mindspace, 80331 Munich. Purpose: Cloudflare is used by our hosting provider as a Content Delivery Network (CDN) and security layer. The ‘__cf_bm’ cookie is set by Cloudflare’s bot-management to distinguish humans from automated traffic and to mitigate DDoS attacks and content scraping in real time. Why we consider this technically necessary: Without bot-mitigation our website would be vulnerable to credential-stuffing, scraping and DDoS attacks that compromise availability, integrity and the security of the personal data we process (e.g. lead-magnet form submissions, newsletter signups). Bot-mitigation is therefore a technical security measure within the meaning of Art. 32 GDPR (security of processing). Cloudflare itself classifies ‘__cf_bm’ as ‘strictly necessary’ (Cloudflare cookie documentation). Replacing Cloudflare bot-management would weaken the security of personal data on this site. Data: IP address, request headers, technical fingerprint of the request. No persistent identifier across sites. Retention: ‘__cf_bm’ cookie expires after at most 30 minutes of inactivity. Aggregated security logs at Cloudflare are retained briefly under Cloudflare’s standard retention. Legal basis: § 25 (2) Nr. 2 TTDSG (technically required to operate the requested service) and Art. 6 (1) (f) GDPR (overriding legitimate interest in a secure, available website). Third-country transfer: Cloudflare is a US group; data may be processed on servers in the USA. Safeguards: EU Standard Contractual Clauses and the EU-US Data Privacy Framework (Adequacy Decision of 10 July 2023). Please note that the legal certainty of the framework may be limited; the General Court of the EU has annulment proceedings pending (case T-553/23). Data processing agreement: concluded as part of the hosting contract. More info:Cloudflare Privacy Policy.
6.8 Google Search Console
Provider: Google Ireland Limited (see 6.1). Purpose: Google Search Console (GSC) lets us monitor how the site performs in Google’s search results — indexing status, search queries that lead to the site, click-through rates, technical crawl errors. Cookies / tracking on visitors: GSC itself sets no cookies on visitors of this website and runs no client-side script. The site ownership is verified by a static HTML meta tag and / or a DNS TXT record. Data: aggregated search analytics from Google’s side (search queries, impressions, clicks); these are not directly linked to individual visitors. The data is made available to us only in aggregated form. Legal basis: Art. 6 (1) (f) GDPR — legitimate interest in monitoring the site’s search visibility. Third-country transfer: the aggregated reporting is generated on Google infrastructure including the USA. Safeguards as in 6.1. More info:Google Privacy Policy.
6.9 Cookie storage durations
Session cookies are deleted when the browser is closed. Permanent cookies have the following maximum lifetimes: Google Analytics 4 — up to 14 months (data retention shortened to 14 months in GA4 settings); Microsoft Clarity — up to 12 months; Google Ads (`_gcl_au`) — up to 90 days; Meta Pixel (`_fbp`) — up to 90 days; LinkedIn (`bcookie`) — up to 6 months; Cloudflare (`__cf_bm`) — at most 30 minutes of inactivity; Leadfeeder — typically session-based, not stored on the device; CookieConsent (Cookiebot) — up to 12 months from the moment consent is given.
6.10 Withdrawal of consent
You can withdraw your consent at any time with effect for the future — withdrawal is as easy as granting consent:
1. Open cookie settings: click the ‘Cookie settings’ link in the footer to re-open the banner and adjust your choice (this controls all of GA4, Clarity, Google Ads, LinkedIn, Meta Pixel and Leadfeeder). 2. By email: send a short message to info@daniel-herrmann.io — we will block the relevant tools for you. 3. Per tool: for Google Analytics the official browser opt-out is available; for Google Ads under Ad personalisation settings; for LinkedIn under LinkedIn opt-out; for the Meta Pixel under Meta ad settings. Microsoft Clarity and Leadfeeder are controlled exclusively via our cookie banner.
The lawfulness of processing carried out on the basis of consent prior to withdrawal remains unaffected (Art. 7 (3) GDPR).
7. Web fonts
This website loads Google Fonts. Connection data (in particular the IP address) is transmitted to Google. Provider: Google Ireland Limited (see section 6.1). Legal basis: Art. 6 (1) (f) GDPR — legitimate interest in a consistent typographic presentation. As an alternative, fonts are also held in a local fallback so that font loading can fail safely without breaking the layout.
8. Technical and organisational measures (TOM)
To protect your data we implement appropriate technical and organisational measures pursuant to Art. 32 GDPR — among them: TLS encryption (HTTPS) for the entire site, encrypted database connections, server hosting in the EU (Kinsta / GCP Frankfurt), restricted admin access via individual accounts with strong passwords and 2FA, regular automatic backups, role-based access controls, a documented record of processing activities pursuant to Art. 30 GDPR, and data minimisation at the application level. We continuously review and update these measures.
9. Your rights
Under the GDPR you have the following rights:
Right of access (Art. 15 GDPR) — information about which of your personal data we process.
Right to rectification (Art. 16 GDPR) — correction of inaccurate data.
Right to erasure (Art. 17 GDPR) — deletion of your data where the legal conditions are met.
Right to restriction of processing (Art. 18 GDPR).
Right to data portability (Art. 20 GDPR) — receipt of your data in a structured, common, machine-readable format.
Right to object (Art. 21 GDPR) — to processing based on legitimate interest, including for direct marketing. See highlighted box below.
Right to withdraw consent (Art. 7 (3) GDPR) — at any time with effect for the future, see section 6.10.
Right to lodge a complaint (Art. 77 GDPR) — with a supervisory authority, in particular in the EU member state of your residence, your workplace or the location of the alleged infringement. Competent supervisory authority for our office location: Independent Data Protection Centre Saarland (Unabhängiges Datenschutzzentrum Saarland), Fritz-Dobisch-Straße 12, 66111 Saarbrücken.
Requests regarding these rights are to be directed to: info@daniel-herrmann.io. We will respond within the statutory period (usually one month).
10. Currency of this Privacy Policy
Last updated: 29 June 2026. We reserve the right to adapt this policy so that it always meets current legal requirements. The current version is always retrievable from this website.
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