Scientist in a lab holding a glass bottle and a dropper

PAS-X

PAS-X is the world's leading MES (Manufacturing Execution System)

PAS-X was developed specifically for the pharma industry and makes paperless manufacturing possible

At AFRY we are experts in implementing PAS-X, and we have designed custom solutions for some of the largest global pharmaceutical companies. We take responsibility for the electronic validation, key user training, and go-live activities. Through mapping of complex workflow and material flow we will find the right design for your needs.

PAS-X solutions cover all the important phases in the production of a pharmaceutical and bio-pharmaceutical products from process development to commercial manufacturing and packaging. This supports all major segments of the pharmaceutical industry, such as vaccines, biopharmaceuticals, solids and liquids.

 

 

Product information

How does it work? Arrow pointing right

An opportunity for paperless manufacturing

PAS-X provides all the essential functions needed for efficient pharmaceutical and bio-pharmaceutical manufacturing. The software is the leading MES for pharmaceutical and bio-pharmaceutical industries. It is used by more than 50 percent of the 30 leading pharmaceutical- and bio-pharmaceutical industries in the world, and in more than 1000 installations across the globe.

PAS-X provides all the essential functions needed for efficient pharmaceutical and bio-pharmaceutical manufacturing. The software is the leading MES for pharmaceutical and bio-pharmaceutical industries. It is used by more than 50 percent of the 30 leading pharmaceutical- and bio-pharmaceutical industries in the world, and in more than 1000 installations across the globe.

  • PAS-X is a MES system developed for the pharmaceutical industry
  • It allows you to have one standard IT-system
  • Functionality meets regulatory requirements such as:
    • EU GMP guidelines GMP Annex 11 for Computerized Systems Guidelines
    • FDA guidelines 21 CFR Part 11 and 21 CFR Part 210/211.
    • Körber, the developers of PAS-X, are DIN EN ISO 9001-certified.
    • High data quality
    • Transparency
    • Traceability

 

PAS-X was developed by Körber in Germany. Take a look at Körber's own one-minute presentation of PAS-X:

Functionality and benefits Arrow pointing right

Electronic Master Batch Record

  • Guides the operators through processes to ensure, that no essential operations are omitted
  • Requests signatures from users, either single or double and depending on the type of user (Operator, supporter, technician).
  • Tells and controls which goods are to be consumed and produced.
  • Manages user rights. It is only possible to see your own rights and you can only perform operations you are authorized for.
  • E.g. someone with QA rights can´t sign an operation, that an operator must perform.
  • The operator can´t use items that are expired or have the wrong item number
  • You can create manual incidents or associate comments

Electronic traceability

  • Easy to trace the history of a batch
  • Bar code system
  • Makes it unnecessary to review stacks of papers e.g. to find a specific batch

Electronic Batch Record

  • Physical operations are reflected in the system and collected in an electronic batch record.
  • Incidents are automatically generated in case of fault management, that must be approved by the QA.
  • Authentication flow controlled by user rights

Inventory management

  • Overview of which items are in stock
  • Physical storage operations are reflected in the system via scanning of barcodes
  • Control of consumables through safety point (replenishment)
  • Control of refrigerated goods, etc.
Main challenges of our clients Arrow pointing right

We often find that our customers demand:

  • Transparent planning for everyone from inventory to finished product
  • An overview of the inventory
  • Fewer manual logbook entries and batch papers
  • Getting used to data discipline
  • Easier traceability

AFRY is a certified PAS-X Endorsed Service Partner

PAS-X approved service partners meet all requirements in Körber’s PAS-X service partner program. The main purpose of the program is to offer our customers safe quality and competence - through our reliable, experienced and certified colleagues.

The certification is renewed at regular intervals to ensure, that all service partners and their colleagues are up to date at all times.

MES_PASX

PAS-X Academy

AFRY works hand in hand with Körber, who has developed PAS-X. For this reason, you receive services of a much higher standard and quality than from third-party providers.

New employees undergo a structured training, that consists of training from our own AFRY Academy and certified PAS-X training at Körber.

We are aware, that only well-trained staff ensures the success of your PAS-X project, and therefore training does not stop after our employees are certified. Our new employees will subsequently be part of a mentoring scheme, where they will gain experience with PAS-X in the field together with our experienced PAS-X engineers.

Contact

AFRY contact person generic image

Jens Gjerløv

Section Manager, Biotech Automation Copenhagen