Document Archiving
Certified GxP archiving. Tailored service
ZAS Document Services offer an exceptional solution for document archiving and data management of physical documents focussed on healthcare and pharmaceutical research and production.
As the only document archive certified both for GLP and GMP, our clients can confirm compliance, rely on standardized high quality, and enjoy utmost peace of mind during their audits.
We provide a seamless end-to-end document management service covering the entire lifecycle. This includes transportation, administration, document archiving, customized access, easy and fast retrieval incl. digitization and document destruction, all with centralized chain of custody under our control.
Delegation of data management unlocks valuable resources, on-demand services like audit support or document digitalization ensure audit readiness, and a swift project helps with urgent matters.
As a document storage company, our GLP and GMP-certified security archives are housed in specially protected, climate-controlled facilities. This ensures optimal storage conditions and the highest safety standards required in the healthcare and pharmaceutical industry.
ZAS is a member of the Rhenus Group, one of the leading logistics companies worldwide, boasting a proven track record of 30+ operational years. By leveraging our robust infrastructure and operational efficiency, our clients benefit from a single-vendor solution, streamlining their document archiving processes. This not only saves valuable time and resources but also ensures clear legal oversight.
Rest assured that your document archiving needs are in the hands of an expert document storage company, giving you utmost peace of mind. Just give us a call, and we will manage your needs for you!
Your benefits for
document archiving
Gain the benefits of GxP-compliant document archiving that ensures compliance, provides fast access, and covers the entire document lifecycle.
GxP-compliance guaranteed
From GLP to GCP and GMP, we stand alone in ensuring adherence to laws and regulations. Whether it’s GCP-archiving with ISF or GMP-compliant logistics, rely in our certified services for unmatched peace of mind.
Fast and easy access & retrieval
Ensure continuous control with a real-time 24/7 stock overview from any location. Initiate quick shipments or true copy creation with a simple click, enabling immediate actions. Even for single documents!
Entire life cycle covered
From transport with our own fleet to storage and clear legal oversight, we’ve got you covered, streamlining your processes and saving you time and resources.
Full-service data management
Simply delegate the data management to us and free up valuable resources! From customized databases to metadata management in single document resolution, we take care of it.
Document types
Document archiving of your physical documents from pharmaceutical research and production and healthcare will be managed at optimal conditions, and any required compliance level:
- Documents of all kinds
- GLP raw data
- Protocols, Reports
- Lab notebooks
- QA documentation
- GMP documents
- Batch records
- GCP trial master files (TMF)
- GCP investigator site files (ISF)
- Patient files
- EEG plots
- X-ray images
- ECG-data records
- Climate-sensitive (historical) documents
ZAS
Document Archiving Suite
Covering logistics to archiving, our all-encompassing document archiving service is customized to meet your distinct requirements, offering either the complete suite or individual modules based on your needs.
Contact our experts
and get a quote!
Pick up
Document transfer under GxP standards
Transports to ZAS archive
- EU-wide logistics operated by ZAS fleet or by partners on a global level
- world-wide CRO archive transfer organization
- On demand GLP/GMP-compliant transport operated by GLP/GMP-trained professionals
- Clear legal oversight: Responsibility transitions to ZAS immediately upon handover
- Temperature-controlled: 15-25°C, 2-8°C
- Seamless track and trace: from the moment of handover
- International organization: ZAS handles import permissions and transfer agreements from outside the EU
Administration
Set up & quality control
ZAS ensures your documents are traceable and in best condition for storage.
- Set up: registration and indexing according to client’s needs
- adding metadata to inventory list (especially for CRO service)
- Initial quality control and change of custody documentation
Archiving
Certified and controlled storage
GxP-compliant, climate-controlled security archives guarantee highest integrity and safety.
- GMP-archives +/- CO2 extinguishing system
- GLP-archives +/- CO2 extinguishing system
- Temperature monitoring & control
- Redundant safety: 24/7 guarded facilities, surveilled archives, monitored systems and data integrity
- Non-GxP archives
- GDPR compliant archiving
Access & Retrieval
Fast and easy at a click
Instant overview and convenient document retrieval.
- 24/7 access: Manage archive anytime from anywhere through our user-friendly Telesto online portal and gain a clear, real-time overview of your stock
- Guaranteed shipment within 24h (dependent on sample): Easily locate your desired batch and get it delivered by our ZAS fleet, irrespective the distance to the archive
- Scan on demand and true copy creation: within 2h
- Single-document-retrieval: Retrieve single documents, leaving the rest undisturbed in the archive
Return or Destruction
Document delivery or disposal
Tailored to specific needs
- Detailed document destruction certificate: audit-proof, specific certification for every destroyed archive
- In-house GDPR-compliant disposal: Responsibility remains with us within the Rhenus Group
Extra Services
On demand
Document digitization
Facilitate your audit readiness with our secure document digitizing service:
- Document scanning on demand (SOD)
- Book scanning (e.g. lab notebooks)
- Digitization of entire GXP archives
- True copy creation for GLP/GMP inspections within 2h
-
- Two digital copies (true copy TIFF-file; PDF/A file with OCR and specified document name)
- Two step audit trail
- GAMP5-compliant validation documentation (validation plan, IQ, OQ, PC, and validation report)
CRO Management
our solution for your archives at contract and clinical research organizations (CROs)
- streamlined and regular transfer of finished GLP and GCP studies from CROs (records, samples, E-Data)
- complete communication with CROs
- world-wide transfer organization
- application for export/import permissions
Inspection Support
Tailored services for audits and inspections
- Client Audits: Expert assistance in managing physical documents and electronic data for audits and inspections. Get true copies overnight or within hours.
- ZAS Audits: We facilitate smooth auditing processes, offering both in-person and digital audits. For smaller scopes, consider our efficient „Remote Audits“, saving time and costs while you remain in your office.
Backup according to §20 AMWHV
- ZAS offers the solution for the GMP archiving requirements according to §20 of the German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) which states that:
„In the event of a closure of the manufacturing or testing facility in which the documentation is stored […], the pharmaceutical company must ensure that the documentation is retained for the entire storage period.“ - This allows our partners:
- to have a backup solution according to §20 AMWHV
- to be able to close the GMP facility…
- to be able to move the GMP facility outside of Germany…
…but keep the records available and GMP-compliant for legal inspection.
Standardized quality and safety
for document archiving
Experience safeguarded continuous quality and peace of mind, with our QM team implementing rigorous, streamlined quality control measures that prioritize your documents with standardized processes for document management.
High-security archives with multi-layered safety measures protect your archive and ensure the safety of your documents and data, optionally with CO2 extinguishing system.
Responsive document management service
A responsive team with a single point of contact attentively listens to your needs, ensuring your projects stay on track with streamlined communication and quick resolution of short-term matters. Our approach is tailored to your needs, as we are well-equipped to handle your unique requirements and offer the flexibility to adjust processes on the fly.
- Agile project planning and execution
- Audit readiness and support
- Single point of contact
- Tailored solutions
Your trusted partner for document archiving
Leveraging our robust infrastructure, extensive experience, and expertise, as a part of the Rhenus family, we offer long-term reliability, operational efficiency, and unwavering stability.
- 30 years+ experience
- 25+ audits per year
- 200+ customers
- 10 mio+ documents
ZAS in numbers
30 years+
experience
500+
customers
20 mio+
documents
20 mio+
pathology samples
1 mio+
cryo samples
10,000+
retention samples
50+ TB
e-data
