Medical Information Services – Accurate, Compliant Inquiry Management for Patient Safety

Timely, reliable medical information (MI) services for human healthcare products in the EU and UK. Pharmafile’s Medical Information team ensures that healthcare professionals, patients, and the public receive accurate, up-to-date, and scientifically sound answers about your medicines, while strictly complying with regulatory and ethical standards. In the UK, MI services are governed by the ABPI Code of Practice and regulatory oversight from the Medicines and Healthcare products Regulatory Agency (MHRA). Our MI specialists handle a wide variety of inquiries from questions about product ingredients and dosing to stability, storage, interactions, and potential side effects  always with patient safety and compliance as the top priority. Every inquiry is an opportunity to identify potential adverse events (AEs), which are then reported to the relevant pharmacovigilance teams in line with MHRA requirements; similarly, Product Quality Complaints (PQCs) raised during an inquiry are documented and escalated to ensure appropriate investigation and resolution. By choosing Pharmafile’s end-to-end MI support, companies can confidently meet their legal and ethical obligations while providing a high-quality service to stakeholders and safeguarding public health. We help you avoid common pitfalls  like missing a safety report hidden in an inquiry or providing an off-label answer that could be considered promotional by implementing robust processes, documentation, and staff training. Our mission is to enhance trust and transparency between pharmaceutical companies and the healthcare community through professional, compliant medical information exchange.

This service is tailored for:

• Pharmaceutical & Biotech Companies Lacking In-House MI Teams: Small to mid-sized MAHs that do not maintain a dedicated medical information department. If you rely on ad-hoc staff (or even sales personnel) to respond to medical queries, we provide a fully managed solution to handle inquiries from healthcare professionals, patients, and consumers. Our service ensures that all queries are answered accurately and documented, relieving your internal teams and reducing the risk of non-compliant responses or missed safety issues. We also support larger companies during peak periods or outside business hours to ensure continuous availability for urgent product queries from any market.
• Firms Requiring Seamless MI–PV Integration: Companies that want their medical information function closely integrated with pharmacovigilance and product quality processes. MI teams are more than just information providers  they are a vital part of a company’s safety and quality processes. If you are concerned about capturing adverse events or product complaints from medical inquiries (a frequent weak point in PV compliance), our service is designed to catch and escalate these seamlessly. We have specialised workflows and training so that any safety information or product issue raised in an inquiry is immediately funnelled to your PV or quality teams. This is ideal for MAHs looking to strengthen their safety surveillance and ensure nothing is lost between departments.
• Multinational Companies Ensuring Consistency and Compliance Across Regions: Organisations that operate in multiple countries and need to provide consistent, high-quality medical information in different languages and markets. We offer multilingual MI capabilities compliant with both EU and UK standards, ensuring a unified approach. By doing so, we help companies maintain a uniformly high standard of medical information across all regions, which is particularly useful during audits and inspections.

(Note: While we manage your medical information inquiries and related procedures, ultimate responsibility for compliance remains with the MAH. Our role is to provide the expert personnel, processes, and tools to meet those obligations effectively on your behalf. We work as an extension of your team, not as a marketing or promotional function, and all our activities are confined to scientific information exchange and regulatory compliance).

Ensuring Accuracy and Consistency Under Scrutiny: Medical Information departments face the challenge of providing timely, accurate, and consistent information in response to an extremely wide range of queries. MI teams respond to inquiries related to product ingredients or excipients, pharmacokinetics, dosing and administration, stability concerns such as temperature excursions, guidance on storage and shelf-life, and information about potential interactions, side effects, and contraindications. The breadth of topics and depth of detail required means MI staff must have rapid access to up-to-date, validated information about your products. Inadequate resources or poorly managed content can lead to inconsistent or outdated answers, which regulators and industry codes deem unacceptable. Our team continuously curates and references approved sources (SmPCs, regulatory documents, published literature) to ensure responses are correct and consistent across different markets and time points.

Handling Off-Label and Promotional Traps: A significant challenge is addressing inquiries about off-label uses or unapproved patient populations. Such questions are often legitimate (e.g. a physician asking about emerging research or a different dosing regimen), but how MI responds is under tight scrutiny. All MI responses must comply with the ABPI Code of Practice, which requires non-promotional responses  information must be factual and unbiased, with no medical advice  MI teams provide scientific data, not treatment recommendations. We prepare responses that provide scientific data without veering into promotional claims or unsubstantiated recommendations. We also clearly disclose when information is outside the approved label and advise that treatment decisions remain the physician’s responsibility. This careful approach prevents breaches of codes of practice and regulatory rules while still being helpful to the requester.

Integrating with Pharmacovigilance and Quality Systems: Medical Information is at the forefront of interactions with HCPs and patients, which means it often receives the first signals of potential safety or quality issues. A classical pitfall is the failure to recognise and report adverse events or product complaints that come through MI. Every inquiry is an opportunity to identify potential adverse events, which are then reported to the relevant pharmacovigilance teams in line with MHRA requirements. If Product Quality Complaints are raised during an inquiry, these are documented and escalated to ensure appropriate investigation and resolution. This two-way communication between MI and drug safety or quality teams strengthens product oversight and supports continuous improvement. Our MI specialists are cross-trained in pharmacovigilance basics; if a caller mentions a possible side effect, our team treats it as a potential suspected adverse reaction and immediately collects the minimum required information and forwards it to the PV team for processing. The SOP framework we follow is applicable not only to medical, regulatory and pharmacovigilance personnel but also to sales, marketing, and general administration personnel when interacting with HCPs, to ensure that any potential medical information request is recognised, documented and transferred to the responsible person for medical information without delay.

Managing High Volumes and Complex Queries Efficiently: Companies can be overwhelmed by the volume of medical information inquiries, especially during product launches, new indications, or in crises (such as product recalls or high-profile safety events). We address this by scaling our resources including knowledgeable professionals and technology  to handle surges and ensure every question gets a timely, well-researched answer. By maintaining detailed workflow metrics (like inquiry volume, response times, customer satisfaction, and escalation rates), we identify and address bottlenecks proactively so that performance remains high even when inquiries peak.

Safeguarding Personal Data and Confidential Information: Medical information requests often involve personal health details and discussion of sensitive data. Data protection is a fundamental part of MI work. Every inquiry, whether from a patient or healthcare professional, involves handling personal data, requiring full compliance with the General Data Protection Regulation (GDPR) and robust internal processes to obtain and document only the necessary data; store all data securely; redact information where required to protect identities; and ensure proper data retention and disposal policies. Our MI platform and processes are built with privacy-by-design; we capture only the minimum necessary personal details, use secure systems to store inquiry records, and ensure data retention policies are adhered to.

European and UK regulators, along with industry codes of practice, have clear expectations for a company’s Medical Information function:

• Accurate, Evidence-Based, and Non-Promotional Responses: In the UK, all MI responses must comply with the ABPI Code of Practice, which establishes ethical standards for the pharmaceutical industry. This means non-promotional responses  information must be factual and unbiased; no medical advice  MI teams provide scientific data, not treatment recommendations; and adherence to the ABPI’s guiding principles  integrity, transparency, and patient-centricity guide every interaction. By following these standards, MI not only ensures compliance but also helps build public trust in pharmaceutical companies. Regulators and auditors may review samples of your written responses to verify they meet these standards, especially if an MI inquiry is related to a compliance complaint.
• Robust Processes for Adverse Event and Quality Complaint Handling: Regulators expect that any part of the company receiving safety information follows defined procedures to report it internally. MI teams are a vital part of a company’s safety and quality processes  every inquiry is an opportunity to identify potential adverse events, which are then reported to the relevant pharmacovigilance teams in line with MHRA requirements. Additionally, if Product Quality Complaints are raised during an inquiry, these are documented and escalated to ensure appropriate investigation and resolution. During inspections, it is common for inspectors to scrutinise the MI function to ensure that no potential adverse event reports were overlooked. The SOP framework we apply ensures that responses to requests for Medical Information are scientifically balanced, medically accurate, and non-promotional in nature, and that all staff who may receive such requests  including sales, marketing, and general administration personnel  are trained to recognise and transfer them without delay.
• Complete Documentation and Audit Trail: Both EU and UK regulators expect that your medical information activities are fully documented and auditable. This includes maintaining a medical information database or log for all inquiries and responses (with dates, details of the requestor, nature of query, and the response provided). Such records are essential not only for operational continuity but also for compliance: an inspector may request to review MI logs to ensure that obligations (like PV reporting and non-promotional standards) are being met. Additionally, if your company uses an external vendor for MI, regulators expect a clear service agreement detailing responsibilities (including pharmacovigilance reporting obligations) and evidence of vendor oversight by the MAH.
• Readiness to Handle Unsolicited Off-Label Queries Properly: Regulatory bodies and codes recognise that companies will receive unsolicited questions about unapproved uses of their products; however, they expect these to be handled in a controlled manner. Answers to off-label queries should be provided only when asked (never proactively), be truthful and limited to the scope of the request and include any relevant safety information or disclaimers about the lack of authorisation for that use. The US FDA has published draft guidance on responding to unsolicited requests for off-label information about prescription drugs and medical devices, and analogous principles apply under UK and EU frameworks. Inspectors or code compliance auditors may review how your MI team handles an off-label request scenario: Was the response non-promotional? Did it stick to factual evidence? We maintain standard response documents for common off-label topics, pre-approved by medical and regulatory departments, to ensure consistency and compliance.
• Data Protection and Privacy Compliance: Given that MI teams often handle personal data from patients or healthcare providers, regulators expect strict adherence to data protection laws like GDPR. By embedding privacy-by-design into every aspect of MI operations, both patient confidentiality and regulatory compliance are upheld at every step. During inspections or audits, authorities may verify that your MI processes incorporate data privacy considerations.

We structure your medical information function to comply with all relevant industry codes and regulations:

• ABPI Code and EFPIA Standards: We operate in strict accordance with the ABPI Code of Practice (for the UK) and the principles of the EFPIA code across Europe, which govern how pharmaceutical companies handle inquiries. This means we ensure that every response is non-promotional, unbiased, and scientifically substantiated. Our team is well-versed in these codes and receives ongoing training to stay current on updates. By aligning with these frameworks, our MI service supports your company’s licence to operate and helps maintain the trust of HCPs and patients.
• EMA & MHRA Expectations: We design our MI processes to satisfy MHRA’s expectations and relevant good practice guidelines. The function intersects with GVP Modules in terms of its contribution to safety monitoring MI supports patient safety through accurate, timely responses; compliance with the ABPI Code and MHRA requirements; vigilant monitoring of adverse events and product quality; and protection of personal data under GDPR. Our MI system is audited regularly to ensure it remains compliant and effective.
• Global Reach with Local Insight: If your operations span multiple countries, we provide a centralised MI platform combined with local knowledge. We can field inquiries in major European languages and ensure that country-specific regulatory nuances are taken into account when formulating answers. Medical information professionals usually work within the medical divisions of pharmaceutical companies, providing evaluated, balanced information on clinical aspects of products  and our service mirrors this standard across all markets we cover.

The foundation of our MI service is a robust, user-friendly inquiry management process:

• Multi-Channel Inquiry Capture: We set up dedicated channels for medical inquiries (phone lines, email addresses, web portals) for your company. We ensure these channels are monitored continuously during agreed hours (and around the clock for urgent medical inquiries if required). Our team immediately acknowledges each inquiry, providing reassurance to the requester that their question is being addressed. We capture all relevant details from the outset: requester information (while adhering to data privacy), product name, batch if relevant, and the exact question or concern. If the inquiry comes through a non-traditional route (for example, a question posed to a sales representative or posted on social media), we have processes to route that information into our system, so it is not missed. This SOP is applicable to sales, marketing, and general administration personnel when interacting with HCPs to ensure that any potential medical information request is recognised, documented and transferred to the local responsible person for medical information without delay.
• Triage and Classification: Upon receiving a query, it is promptly triaged for priority and complexity:
  • Urgent or emergency inquiries (e.g. questions about managing an overdose or an acute safety concern) are immediately escalated to a medical professional on our team for rapid response, often within hours.
  • Standard inquiries (e.g. questions on indications, dosing, formulation details) are classified by category and routed to an appropriate specialist. We use a database of standard response documents (SRDs) covering common questions about each product these SRDs are pre-approved, scientifically vetted answers that ensure consistency and save time.
  • Special inquiries that require customised responses (e.g. a question about an off-label use or a complex polypharmacy interaction) are assigned to our senior medical information pharmacists or physicians for bespoke handling.
  • Each inquiry is logged and given a unique identifier in our secure MI database, with timestamps for when it was received, acknowledged, and answered, ensuring a full audit trail.

Quality-Controlled Response Creation: For every inquiry, we prepare a written response (even if the answer is also provided verbally, we follow up in writing for completeness). All responses undergo quality control by a second professional before they are sent out. The core principles used ensure that responses to requests for Medical Information are accuracy, clarity, completeness, and compliance with all relevant guidelines. If a query falls outside the scope of what we can provide (e.g. a patient asking for personal medical advice), we respond with an appropriate disclaimer and guidance.

Pharmafile’s MI service is tightly interwoven with pharmacovigilance processes to support comprehensive safety monitoring:

• Adverse Event Identification and Reporting: Every MI professional is trained to spot potential adverse events or special situation reports (such as pregnancy or medication errors) that may be hidden within an inquiry. MI teams are a vital part of a company’s safety and quality processes  every inquiry is an opportunity to identify potential adverse events, which are then reported to the relevant pharmacovigilance teams in line with MHRA requirements. For instance, if a healthcare professional’s question mentions that a patient experienced a certain side effect, we treat that as a suspected adverse reaction report. Our internal PV agreements stipulate that any spontaneous ICSRs and safety information regarding special situations associated with products, as well as any medical enquiry, received by a partner should be sent to the MAH in accordance with defined timelines. This practice ensures that all company units (including Medical Information) promptly share safety information internally.
• Product Quality Complaint (PQC) Handling: If Product Quality Complaints are raised during an inquiry, these are documented and escalated to ensure appropriate investigation and resolution. This two-way communication between MI and drug safety or quality teams strengthens product oversight and supports continuous improvement. We follow your internal quality SOPs or can leverage our own established procedures to ensure the complaint is logged, triaged, and investigated. By systematically sharing such information, we prevent gaps where a quality issue reported to an MI agent falls through the cracks.
• Two-Way Communication and Follow-Up: We do not just forward information; our MI team remains engaged in the follow-up process. If an adverse event is reported through an inquiry, our MI agent will inform the reporter that their information has been shared with the safety team, and if appropriate, that they or their patient may be contacted for further details. We also ensure that if the PV or QA team needs additional information from the initial inquirer, our MI staff facilitates that follow-up. Source documentation received in electronic format as well as any physical source documents should be scanned and forwarded with an English translation if the original language was not English. This closes the loop and demonstrates to inspectors that inquiries leading to safety or quality issues are properly managed from first report to resolution.
• Governance and Agreements: In cases where medical information services are provided via third-party arrangements, regulators expect clear documentation of responsibilities. We provide all required content for your Pharmacovigilance System Master File and/or Quality System describing how the MI process is outsourced and integrated. Our agreements detail that responsibilities include handling medical information queries and maintaining relevant safety information in line with EU and local applicable regulations. By having these agreements and processes in place, we ensure compliance and clarity of roles, satisfying regulators that the MAH retains full oversight of outsourced activities.

We can maintain strict control over the content and quality of information provided:

• Standard Responses and Approval: We develop a library of Standard Response Documents (SRDs) for frequently asked questions about each product. These SRDs are prepared using the latest approved labelling, published literature, and global company guidelines, then reviewed and approved by your medical/regulatory team. This ensures that whenever a common question arises, our team can quickly provide a vetted answer that is consistent no matter who asks or when. Regular content review schedules are set up (at least annually or whenever there is a significant change such as a label update) to keep all SRDs current. This level of content governance addresses a typical audit issue: regulators often examine whether the information given out by different staff or at different times is uniform and based on the current approved data.
• Handling Unsolicited Off-Label Queries: Our policy is to respond to off-label questions only when they come unsolicited (i.e. we do not prompt or encourage such inquiries) and to do so in a scientifically balanced, non-promotional manner. Information must be factual and unbiased, and MI teams provide scientific data, not treatment recommendations. For example, if a physician asks about using your drug in a population or indication not in the SmPC, we will provide a factual summary of any available data without extrapolation or any suggestion of usage. We clearly state when something is outside the authorised indication and, if appropriate, advise that the healthcare professional use their clinical judgement or consult specialist literature. The US FDA has published guidance on responding to unsolicited requests for off-label information about prescription drugs and medical devices, and we align with these principles globally. This careful approach protects you from compliance breaches.
• Comprehensive Logging and Documentation: Each inquiry we handle is documented in our Medical Information database, including the original question, the details of the requester (in anonymised form for patient requests), the response provided, sources used to answer, and timestamps of all actions (receipt, response, any follow-up). We also document any internal consultations (for example, if we had to seek advice from a medical advisor or you as the MAH to craft an answer). Mandatory staff training on this SOP is included, and key responsibilities are clearly assigned  including the role of Medical Inquiry Recipient (anyone who can possibly receive and forward the inquiry to the MI administrator for data entry). This level of documentation means that in an inspection, we can readily produce logs or even specific correspondence if needed.
• Quality Review and Continuous Improvement: We periodically analyse the inquiries we receive for trends that might indicate emerging issues or opportunities. For example, if we receive multiple queries about administering your product through feeding tubes, we might flag this to your medical affairs team as useful insight, and simultaneously ensure our standard responses cover this topic comprehensively. By treating MI as a two-way knowledge conduit, we not only answer questions but also provide you with feedback that can improve patient and prescriber understanding of your product’s use.

We can help you avoid frequent mistakes related to the medical information function that regulators and auditors often highlight:

• Missed Adverse Events or Poor Handoffs to PV: A top audit finding is that medical inquiries mentioning adverse events or other safety data were not properly reported to the PV department, leading to under-reporting of ICSRs. For instance, an HCP might call with a question and casually mention a patient side effect, which the MI agent fails to interpret as a reportable adverse event. Our procedures are designed to prevent this scenario: all MI staff are trained in pharmacovigilance basics, and our system forces a decision on whether each inquiry contains safety or quality information. We also perform regular reconciliation between the MI database and the PV database to verify that no case was overlooked.
• Non-Compliant Responses (Promotional or Inaccurate Content): Another pitfall is when MI inadvertently provides responses that are promotional or include superlative claims for example, an overenthusiastic statement that a product is “completely safe” or “the best in class” or sharing an off-label dosing regimen as a treatment recommendation. Information must be factual and unbiased and MI teams must provide scientific data, not treatment recommendations. We avoid this by enforcing a strict four-eye review on all written responses, using only vetted content, and training our team thoroughly on what constitutes a promotional claim.
• Inadequate Documentation and Retention: Some companies have faced criticism for failing to document medical information exchanges, or for not retaining records long enough. Our MI system keeps an audit-trailed record of every inquiry and the corresponding response. We align with your retention policies and ensure that any time a question arises  from an internal review, an audit, or even legal inquiries  you have the data to show what information was provided.
• Untrained Personnel and Internal Awareness: Regulators expect that not just the MI team, but all customer-facing staff can identify a medical information query and handle it appropriately. A common gap is when non-MI staff (like sales reps, medical liaisons, or call centre operators) are not trained to recognise and report safety information, leading to under-reporting of adverse events or delays. The applicable SOP framework extends to sales, marketing, and general administration personnel when interacting with HCPs to ensure that any potential medical information request is recognised, documented and transferred to the local responsible person for medical information without delay. We help establish company-wide PV awareness through training programmes and simple reporting mechanisms so that everyone knows how to route a safety issue appropriately.
• Resource and Capacity Issues: Understaffed MI functions can lead to delays in responses or errors, both of which can draw regulatory scrutiny. With our service, you have a scalable team. We adjust resources to handle increased volume (for example, during a new product launch or a crisis where query volumes spike). This flexibility means you will not be caught in a situation where inquiries back up or rushed answers slip through unchecked.

Our Medical Information services can be available and compliant across all European countries and the United Kingdom:

• European Union: We provide MI support that meets the regulatory expectations of EU member states. MI services are guided by frameworks including the EFPIA code and comparable national codes of practice in individual member states. We ensure that across the EU, our responses adhere to local language requirements and any country-specific codes. Our team is aware of these and will tailor the approach if needed, always defaulting to the most conservative and compliant standard across jurisdictions.
• United Kingdom: In the UK, MI services play a critical role, governed by the ABPI Code of Practice and regulatory oversight from the MHRA. Companies are expected to provide a medical information service and to ensure all material is compliant. We operate fully within this framework and liaise with the MHRA when needed. By capturing AEs and product complaints from MI inquiries, we directly support your compliance with UK pharmacovigilance and product vigilance regulations which the MHRA enforces. In the UK pharmaceutical industry, MI teams are a strategic partner in ensuring patient safety through accurate, timely responses; compliance with the ABPI Code and MHRA requirements; vigilant monitoring of adverse events and product quality; and protection of personal data under GDPR.
• Global Considerations: Our primary focus is EU and UK compliance, but our approach is informed by global standards. If your company operates in other markets, we can adapt our processes to those regions’ expectations, ensuring that the core principles of accuracy, compliance, and timely communication remain consistent worldwide.

Through our experienced team and robust processes, we can prevent a number of frequent issues that can compromise the efficacy and compliance of medical information operations:

• Unintentionally Promotional or Inaccurate Information: One of the biggest risks in medical information is providing an answer that is seen as promotional (or worse, incorrect). Information must be factual and unbiased, and MI teams must provide scientific data, not treatment recommendations, in adherence to the ABPI’s guiding principles of integrity, transparency, and patient-centricity. By using approved content and a multi-tier review process, we ensure that no information goes out unchecked. Our responses stick to the facts  if a question cannot be answered definitively (perhaps the data is not available), we say so rather than speculate.
• Delayed or Neglected Responses: Another common failing is slow turnaround or even missed responses, which can happen when internal teams are overburdened or when inquiries fall into a “no man’s land” between departments. We address this by ensuring all inquiries are centrally tracked and by adjusting our team size in real-time to match inquiry volume. Our system of acknowledgments and follow-ups ensures that an inquiry cannot be forgotten.
• Poor Integration with Safety/Quality Systems: The two-way communication between MI and drug safety or quality teams is what strengthens product oversight and supports continuous improvement. Our integrated approach ensures no safety or quality signal is missed. We regularly reconcile MI and PV logs to confirm that every forwarded case was received and processed by PV.
• Inadequate Training and SOPs: Regulators expect companies to have SOPs covering medical information processes and to train all relevant personnel. A mistake, for example, is failing to train sales or customer service staff to recognise a medical information request or an adverse event. The SOP scope must be applicable to sales, marketing, and general administration personnel when interacting with HCPs to ensure any potential medical information request is recognised, documented and transferred to the local responsible person for medical information without delay. We provide comprehensive SOPs for the entire inquiry handling process and offer training and support to any of your staff who might act as medical inquiry touchpoints. The key responsibility of the Medical Inquiry Recipient is defined as anyone who can possibly receive and forward the inquiry to the MI administrator for data entry.
• Regulatory Knowledge Gaps: The landscape of what can or cannot be said in a medical information response is shaped by a combination of regulations, guidelines, and codes. A company that is not deeply familiar with these can inadvertently stray into non-compliance for example, providing off-label dosage guidelines (which could be construed as advising an unapproved use) or failing to include necessary disclaimers. Our team stays current with all relevant regulatory changes and systematically updates our practices and content in response.

Medical Information does not operate in isolation. We ensure our MI service is integrated with your other functions and with Pharmafile’s range of support offerings:

• Pharmacovigilance Services: Given the tight link between MI and drug safety, our Pharmacovigilance Services are a natural complement. We can manage your adverse event reporting, signal detection, and risk management activities hand-in-hand with MI. If we provide both MI and PV services, an adverse event mentioned in a call to the MI line can be immediately processed as an ICSR by our PV staff without any delay or information loss. (See our Pharmacovigilance Services page for details on safety data management.)
• Quality Services: Our Quality Assurance Services cover product complaint handling and regulatory compliance for manufacturing and distribution (GMP/GDP). We collaborate with QA such that any product quality defect reported via MI is not only passed on but also followed through. (Refer to our Quality Services page for how we manage product quality issues and recalls).
• Regulatory Affairs & Medical Writing: Our Regulatory Affairs Management team and Medical Writing experts support MI by ensuring that the latest approved product information (SmPC, PIL) and company Core Data Sheet information are readily available for reference. If an inquiry suggests that an update to product labelling or educational materials might be needed, we can involve our regulatory team to assess if a label change is warranted. (See Regulatory Affairs Management and Medical Writing for related services).
• Training & Compliance Consulting: We offer training programmes for internal staff about identifying and forwarding medical inquiries and adverse events, which many clients integrate into their new-hire onboarding or sales training. Additionally, our compliance experts can audit your in-house MI processes and recommend improvements, even if you do not fully outsource the service to us.