Retention Sample Archiving
The pioneering external GxP retention sample archiving solution
ZAS GxP Sample Services introduce a unique external storage solution for retention samples, customized for clients operating worldwide in the pharmaceutical, biotechnology and healthcare sectors.
We provide a seamless end-to-end service that spans the entire retention sample lifecycle. This includes transportation, administration, secure archiving, customized access, easy and fast retrieval, or destruction – all managed with a centralized chain of custody under our control.
By taking advantage of this unique opportunity, our clients can streamline operations, save resources by eliminating in-house storage efforts or enjoy competitive pricing, and benefit from a single-vendor solution with clear legal oversight.
As the only archive with a unique certification coverage including GMP/cGMP and Manufacturing Authorization §13 AMG, our clients can confirm compliance, rely on standardized high quality, and enjoy peace of mind for audits.
Our GLP and GMP-certified security archives are housed in specially protected, climate-controlled facilities. This guarantees the highest level of sample integrity and safety while maintaining agreed storage conditions from handover.
ZAS is a member of the Rhenus Group, one of the leading logistics companies worldwide, supported by a solid infrastructure, operational excellence, and a proven track record of 30 operational years.
Your benefits for retention sample archiving
Take advantage of the industry’s first off-site GxP sample archiving solution that resource-efficiently manages batches of any size with a unique level of certification coverage.
The first of its kind
A pioneering GxP retention sample external archiving solution that offers end-to-end life cycle management for batches of all sizes.
Resource-saving
Eliminate in-house storage operating costs, reduce compliance and QM efforts, free up management attention, or benefit from competitive pricing enabled by our extensive infrastructure.
Unique certification coverage
Not just compliant, but certified. As the only archive with GMP/cGMP, §13 AMG, and EU GMP, we stand alone in ensuring compliance with all relevant regulations.
Fast and easy access & retrieval
Ensure continuous control with a real-time 24/7 stock overview from any location. Initiate quick shipments with a simple click, enabling immediate actions.
Retention sample types
We are equipped to store batches of all sizes under compliant and safe conditions in climate-controlled storages:
- API (Active pharmaceutical ingredient) requiring manufacturing authorization (acc. §13 German Medicinal Products Act)
- Medicinal product (acc. §2 German Medicinal Products Act)
- Investigational medicinal product (§3 German GCP Ordinance)
- Reserve/Retention samples: Active pharmaceutical ingredient (acc. §18 / §27 AMWHV)
- Retention samples: Medicinal Product (acc. Annex 19/§18 AMWHV)
- Reference samples: Medicinal Products (acc. Annex 19)
- Retention samples: Investigational Medicinal Products (acc. Annex 19/§18 AMWHV)
- Reference samples: Investigational Medicinal Products (acc. Annex 19)
- Stability samples API
- Stability samples Medicinal Product
- Stability samples Investigational Medicinal Product
- Analytical samples, test items
- Seed material
- Medical device retention samples
- Samples from industry production
ZAS Retention Sample Suite
From logistics to storage, our extensive offering for retention sample archiving is designed to suit your specific needs. Whether you opt for the entire suite or select individual modules, our tailored approach ensures a perfect fit for your requirements.
Contact our experts
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Administration
Set up & control
ZAS ensures your retention samples are traceable and in best condition for storage.
- Set up: registration and indexing on individual batch level
- Control: e.g. optical control of batches
Archiving
Certified and controlled storage
GxP-compliant, climate-controlled security archives guarantee highest integrity and safety.
- Tailored storage temperatures: 8-25°C or on demand
- Redundant safety: 24/7 guarded facilities, surveilled archives, monitored systems and data integrity
Quality Assurance
Permanent quality management and control
Safeguarding retention sample integrity, access and climate control and safety throughout the storage duration
Access & Retrieval
Fast and easy at a click
Instant overview and convenient 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
Extra Services
On demand
Secondary Packaging Labelling
Reliable labelling of retention samples
- ZAS ensures that your secondary packaging labels adhere to the latest regulatory guidelines, providing you with peace of mind and regulatory compliance of your retention samples.
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…
…but keep the records available and GMP-compliant for legal inspection.
Audit support
Tailored services for audits and inspections
- Client Audits: Expert assistance in managing physical documents, electronic data, and biological samples 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.
Redundant safety for retention samples
Standardized quality in
retention sample management
Enjoy continuous quality and peace of mind as our Quality Management team rigorously enforces streamlined control measures. We prioritize your batches with standardized processes for retention sample management in accordance with regulatory compliance.
Responsive service
Our responsive team with a single point of contact attentively listens to your needs, while keeping your projects on track with streamlined communication and quick resolution of short-term issues. Our approach is tailored to your needs, as we are well-equipped to handle your unique requirements and offer the flexibility to adjust processes where needed.
- Single point of contact
- Tailored solutions
- Audit support
Your trusted partner for Retention Sample Archiving
Leveraging our excellent infrastructure, operational efficiency, 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
- 10.000+ retention samples
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
