Pharmaceutical and Medical Device Verification: Certified Digital Evidence

Forensic certification of inspections, audits and verifications to ensure document integrity, supply chain traceability and regulatory compliance.

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The pharmaceutical and medical device industry operates under increasing regulatory pressure. Every inspection, every compliance verification, every supply chain audit generates digital evidence: batch photographs, inspection videos, serialization documents, non-conformity reports. This evidence must be authentic, unaltered and traceable to withstand scrutiny from regulatory authorities. With pharmaceutical counterfeiting generating billions in illicit revenue and European regulations (MDR, EU Reg. 2016/161) requiring increasingly rigorous documentation, relying on photographs and reports without authenticity guarantees exposes organizations to legal risks, sanctions and disputes.

TrueScreen certifies every piece of evidence at the point of collection, with digital signature, qualified timestamp and verified metadata, transforming verification activities into documented processes with full legal validity.

Industry

Pharmaceutical and medical devices

Business Function

Protezione civile, Operations, Sinistri e liquidazione, Risk management, Compliance, Legale

Key Process

Valutazione danni, gestione interventi e ripristino, gestione sinistri e rimborsi, audit post-evento

Certified Content

Foto, video, audio, screenshot, navigazione web, verbali di sopralluogo

Output

Certified documentation and reporting with legal validity

Adoption Mode

App / Web / API / SDK

Needs

  • Inspection evidence lacking authenticity guarantees on date, location and acquisition device
  • Documentation compliant with MDR 2017/745, EU Reg. 2016/161 and FDA 21 CFR Part 820
  • Chain of custody broken during transitions between field collection and archiving
  • Documentation consolidation times that slow down operational decision-making
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processo

Solution

TrueScreen enables inspectors, Quality Assurance managers and field operators to certify every piece of digital evidence at the point of collection. Every batch photograph, every inspection video, every traceability system screenshot is captured with verified metadata (GPS position, date and time, device), digitally signed and equipped with a qualified timestamp compliant with eIDAS.

The result is verification documentation with a complete and unbroken chain of custody, ready for regulatory audits, legal proceedings and compliance checks.

What gets certified

Batches and Packaging

Photographs of batches, packaging, labels and Data Matrix codes for serialization verification with certified position metadata and timestamps

Video Inspections

Video recordings of inspections in manufacturing facilities, warehouses and distribution centers with intact chain of custody from recording

Traceability Systems

Screenshots of traceability systems and digital supply chain records, environmental condition recordings during storage and transportation

Reports and Audits

Non-conformity documents, pharmacovigilance reports and audit reports digitally signed with immutable metadata and legal validity

Expected benefits

  • Inspection documentation with full legal and evidentiary value for audits and proceedings
  • Reduced risk of disputes through evidence with certified date and position
  • Documentation consolidation times reduced from days to minutes
  • Documented compliance with MDR, EU Reg. 2016/161 and FDA regulations
  • Complete and unbroken digital chain of custody for every piece of collected evidence

Partners

Pharmaceutical companies, medical device manufacturers, distributors and wholesalers, notified bodies, regulatory consulting firms, testing and quality control laboratories.

Integrations

Quality Management Systems (QMS) compliant with ISO 13485, serialization and traceability platforms (EU FMD, US DSCSA), pharmaceutical ERP systems, pharmacovigilance platforms, document archives compliant with 21 CFR Part 11.

Related use cases

FAQ: Certified Pharmaceutical and Medical Device Verification

1) What types of digital evidence can be certified during a pharmaceutical inspection?
TrueScreen certifies batch and packaging photographs, inspection videos in manufacturing facilities and warehouses, traceability system screenshots, non-conformity documents, pharmacovigilance reports and environmental condition recordings during storage and transportation. Every piece of content receives a digital signature, qualified timestamp and verified metadata at the point of collection.
2) How does TrueScreen ensure compliance with MDR 2017/745 requirements?
TrueScreen certification produces documentation with a complete chain of custody, digital signature and qualified timestamp compliant with eIDAS. This satisfies the traceability, data integrity and audit trail requirements set by EU Regulation 2017/745 on medical devices, EU Delegated Regulation 2016/161 on medicine serialization and FDA regulations (21 CFR Part 820 and Part 11).
3) How does certification protect the chain of custody for inspection evidence?
Every piece of evidence is digitally signed at the point of field collection, with immutable metadata: GPS position, date and time, device. From the moment of acquisition to archiving, the content cannot be altered. This eliminates the typical vulnerabilities of transfers via email, cloud or local copies that characterize traditional processes.
4) How much time is saved in producing audit documentation?
The TrueScreen Workflow Engine automatically organizes evidence according to the inspection structure and generates certified technical reports at the end of the assessment. Inspection documentation consolidation times are reduced from days to minutes, eliminating the manual assembly, verification and distribution phase.
5) Can certified documentation be used in legal proceedings?
Documentation produced by TrueScreen has full evidentiary value thanks to the digital signature and qualified timestamp compliant with eIDAS. Every piece of evidence is linked to the time, place and operator who captured it, with a complete and verifiable chain of custody. This makes it admissible in regulatory audits, supplier disputes and judicial proceedings.
6) How does TrueScreen integrate with existing Quality Management systems?
TrueScreen integrates with QMS systems compliant with ISO 13485, serialization and traceability platforms (EU FMD, US DSCSA), pharmaceutical ERP systems and document archives compliant with 21 CFR Part 11. Certified documentation is made available through a centralized archive to Regulatory Affairs, Quality Assurance functions and competent authorities.

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