“The Output Management software ensures that our colleagues always have the correction version.”
Dr. Georg Schwarz, Corden Pharma
About Corden PharmaCorden Pharma operates as a legally independent unit within the Corden Group and has been a company of the International Chemical Investors Group since 2008. ICIG is a privately owned holding company and has acquired more than 15 independent, mid-sized chemicals and pharmaceutical businesses to date.
Corden Pharma looks back on a 25-year history of success in the areas of purification of active ingredients, production and packaging of solid and liquid pharmaceutical products on behalf of diverse providers. The company is also involved in the manufacture and distribution of clinical trial drugs and supplies clients in more than 30 countries around the world.
Pills are manufactured in a containment facility, which uses a closed system to process highly effective substances with MACs of up to 0.001 mg/m³. The facility is thus perfectly suited to the manufacture of hormones and hormone blockers.
Contract manufacturer Corden Pharma solves these critical business tasks using sophisticated document management in SAP with the support of the CIDEON solutions Conversion Engine and Output Management. These system components are managing approximately 20,000 active documents of up to one hundred pages, even when many of them must be regularly revised.
Today, employees from all departments in the company - from goods receipt to laboratories, quality control, production, packaging, warehousing and shipping - have access to these documents with various authorizations. Around 120 employees have authoring rights, 30 are permitted to approve documents and an additional 40 employees have read-only access.
In the jargon, these are called GMP documents or “good manufacturing practices” documents, which refers to documents created in the manufacture and distribution of medical products for people and animals. These documents are subject to the most stringent of security standards.The document-management system at Corden Pharma converts up to 300 updated GMP documents and carries out over 160 print jobs each day. “We are very happy with the system,” comments Dr. Georg Schwarz, the project manager at Corden Pharma. Taking circumstances into consideration, that was not necessarily to be expected. The selection and rollout of the new system, including the migration of 30,000 documents, had to be accomplished within seven months’ time. “It took several weeks just to validate the data that was transferred,” says the system manager.
Motivation for a New System
The impetus to look for a new data-management system resulted from the takeover of the company site by the ICIG Group, which meant replacing the previous information technology. “Because the previous system was cut off, our old document-management system was history after just eight months," remembers the project manager. “This task is essential to our survival as a company, so we had to find a new solution quickly.”
Because Corden Pharma was already using SAP as an ERP system and considers it a strategic platform, the software of choice was the SAP document-management system. It was only necessary to add the document-management components and migrate the legacy data; these tasks were completed by internal SAP specialists with support from an external consulting firm.
CIDEON Conversion Engine, which is integrated in the system, optimizes document flow by ensuring consistent document-naming conventions across the entire life cycle. Users can place qualified electronic signatures on documents and take advantage of versatile tools to make comments on and mark up PDFs. These can then be imported, for instance, as digital stamps or watermarks, which ensure that documents can be uniquely identified and eliminate any questions as to the document’s status. Investments in additional Adobe licenses are eliminated through the use of CIDEON’s own PDF Suite.
Output Management, which can be individually customized, automates the output and distribution of any type of document. At Corden Pharma, these documents include regulations, forms and work instructions known in the pharmaceutical industry as standard operating procedures (SOPs).
The company must update many of these documents periodically: Each year, as many as 2,500 new versions are created, which the authors edit in Word and, after approval, distribute to the employees responsible in PDF format. “The Output Management software ensures that our colleagues always have the correction version,” says Dr. Georg Schwarz.“We don’t carry out a single step without documentation,” explains the project manager. As an example, he cites a production form or manufacturing guideline, which is used in the production of the above-mentioned pills for treating high blood pressure. The operator in manufacturing enters on the form the amount of a particular active ingredient he has added and verifies the step by signing his initials. The form is then sent to the employee responsible for the next work step.
Flexible, Modular Design
Dr. Georg Schwarz especially appreciates CIDEON Output Management’s easy handling and flexibility, which have allowed the more than 65 print layouts previously in use to be pared down to just eight versions. “It’s like using building blocks: We can combine individual elements and reuse combinations in other places,” says the system manager of the increase in efficiency. The elements used run the gamut from the header with a digital stamp for scope of application to the list of approvals including dates.
All of the legacy templates were also able to be directly inherited, meaning that no formatting adjustments, such as changing margins, were necessary. “At first glance, that may seem trivial, but when you have to go through tens of thousands of documents, it adds up,” emphasizes the project manager.
Lot documentation, which consists essentially of a lot number Corden Pharma prints on blister packs and folding boxes, presents special challenges for print management. It serves as a reference so that a medication can be tracked from start to finish if necessary. The manufacturer must retain the respective documentation for 30 years. “It is probably the most delicate document in our business,” says the system manager.
Even so, to automate this task as much as possible, CIDEON integrated its Output Management software into the specific production planning and control at Corden Pharma. In this way, the lot documentation for a medication, for instance, can be generated directly from the production order, with the significant advantage that the lot number functions as a link between the manufacturing process and the stamped final product. Consistent documentation in the SAP ERP system throughout the process is also based on the lot number.
Dr. Georg Schwarz illustrates the system’s importance to the company with a practical example. If an inspector from the regulatory authority requests a particular document during a routine inspection, the document must be made available within 15 minutes. The specific challenge in this case is to find and print the requested PDF from among the 20,000 active and 10,000 inactive documents being maintained.
“Our experience with CIDEON has been very positive,” summarizes the project manager. When questions have come up, the software manufacturer has provided prompt support by hotline or remote access. “Only rarely have I experienced a help desk that reacts so quickly and competently.”Based on the positive feedback, the system has been implemented at a second Corden Group site, where the project was completed in two and a half months and approximately 12,000 legacy documents were migrated.
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