PIM/DAM in regulated markets – pharmaceuticals, medtech and healthcare products
PRODUCT EXPERIENCE MANAGEMENT
Whether pharmaceuticals, medical technology or healthcare products – strict legal requirements apply in all areas. Regulations such as the EU Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR) and the US FDA CFR Part 11 leave no room for manoeuvre: product information and accompanying documentation must be accurate, traceable and complete at all times.
But this is precisely where many companies in the healthcare sector are lagging behind. Data and documents are scattered across Excel files, ERP systems and local storage locations. The result: inconsistencies, errors and compliance risks. The solution? PIM and DAM systems that serve as a central platform for data management.
Typical challenges without PIM/DAM in regulated markets
Communication errors: Incorrect dosage information or incomplete operating instructions can result in recalls – with immense costs.
Data chaos & redundancies: Product information is available in different versions – often contradictory.
No traceability: Who changed what and when? Audit trails are missing in audits.
High manual effort: Regulatory authorities require evidence, companies have to laboriously gather data.
Compliance and regulatory requirements in the pharmaceutical and medtech sectors
Regulated markets require more than just “proper data maintenance”. Clear guidelines apply:
Multilingualism: Product information must be available correctly and consistently in all markets.
Documentation requirements: Every change to product information must be verifiable.
Quality management: Standards such as ISO 13485 prescribe structured processes and data management.
Rapid adaptability: Changes in legislation or new security requirements must be implemented promptly.
PIM/DAM as a solution: Single Source of Truth
Product Information Management (PIM) and Digital Asset Management (DAM) create the basis for meeting these requirements efficiently and securely:
Rapid distribution across all channels
Whether it’s packaging, your website or online shop – changes are available immediately.
Central database (single source of truth)
All product information and accompanying assets (e.g. package inserts, technical drawings, safety data sheets) are stored in one place.
Versioning & audit trails
Every change is documented: who changed what and when. This fulfils the obligation to provide evidence to authorities.
Approval workflows & role models
Changes to product data undergo defined review and approval processes. Only approved information reaches the market.
Multilingualism & translation management
Mandatory information can be managed centrally and automatically output in multiple languages – consistently and error-free.
Integration into existing systems
Connection to ERP, CRM or regulatory databases ensures consistent processes without media discontinuity.
Practical examples: PIM/DAM in pharmaceuticals, medtech and healthcare
- Pharmaceuticals: Package insert changes (e.g. dosage) are maintained centrally and automatically rolled out in all language versions and channels.
- MedTech: Operating instructions and safety-related information are versioned, checked and stored in an audit-proof manner.
Healthcare products: Packaging, online shops and marketing materials receive consistent data from a single source.
Why apollon is the right partner
With our OMN platform, we offer an integrated solution for PIM, DAM and content management that is precisely tailored to these challenges.
- OMN guarantees a single source of truth for all product information.
- Compliance is ensured through audit trails, approval processes and clear role models.
- Thanks to its modular architecture, OMN can be seamlessly integrated into existing IT landscapes – whether ERP, CRM or industry-specific systems.
- This enables companies in regulated markets not only to minimise risks, but also to shorten their time-to-market and reduce costs.
GMP, FDA CFR Part 11 and international standards: requirements beyond the EU
While MDR and IVDR define the European regulatory framework, internationally operating pharmaceutical and MedTech companies face additional requirements — in particular for the US market.
FDA 21 CFR Part 11: electronic records and signatures
The US Code of Federal Regulations, Title 21, Part 11 (FDA CFR Part 11) governs requirements for electronic records and signatures in the pharmaceutical and medical device sectors. The core requirement: electronic records must be as secure, traceable and tamper-proof as physical documents with handwritten signatures.
For product data systems, this means in concrete terms:
- Access control with unique user identification
- Complete audit trail: every creation, modification or deletion of records must be logged with date, time and user ID
- Data may not be rendered unrecognisable retrospectively — only new versions may be created
- Electronic signatures in approval processes must be unambiguously assigned to a person
A PIM/DAM system that does not structurally meet these requirements is not a viable tool in the FDA-regulated environment — regardless of its other functions.
GMP (Good Manufacturing Practice)
GMP guidelines — regulated in the EU by EU GMP (EudraLex Vol. 4) and harmonised internationally by ICH guidelines — primarily concern the manufacture of pharmaceutical products. Of particular relevance for product data and documentation are:
- Document control: All product-related documents (specifications, manufacturing instructions, quality records) must be controlled, versioned and approved according to defined processes
- Change control: Changes to product specifications or processes require a formal approval process with risk assessment and documentation
- Data integrity (ALCOA principle): Product data must be Attributable, Legible, Contemporaneous, Original and Accurate — a direct set of requirements for data management systems
OMN supports GMP-compliant processes through configurable change control workflows, complete versioning at document and data field level, and a role model that maps GMP-compliant access structures.
Differentiation: what makes PIM/DAM different in regulated markets compared to standard retail
A PIM system for a fashion retailer and a PIM system for a pharmaceutical company share similar basic functions at first glance: capture product data, maintain it, distribute it to channels. The differences lie in the details — and these details are decisive in regulated markets.
In standard retail, what matters is: time to market, conversion optimisation, channel-appropriate data preparation, rapid seasonal range changes.
In regulated markets, additionally:
- Immutability of approved versions (no retrospective overwriting)
- Formal approval processes with defined roles and escalation paths
- Authority-ready audit trails (who changed what and when — without gaps)
- Safety-relevant data must be updatable quickly and verifiably in all markets
- Multilingualism is not a feature but a regulatory obligation
These requirements justify a different system decision: not the cheapest PIM solution or the easiest to use — but the one that structurally meets these specific compliance requirements.
Conclusion: Without PIM/DAM, it becomes risky
In regulated markets, mistakes are not an option. An inconsistent data set or a missing document can lead to production stoppages, recalls or fines.
PIM and DAM systems are therefore not only a tool for efficiency, but also an indispensable part of compliance strategies.
Companies that want to manage their product information securely, transparently and sustainably will find apollon to be the ideal partner.
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