Government agencies around the world, including the US Food and Drug Administration (FDA), use current Good Manufacturing Practices (cGMP) as the primary way to ensure pharmaceutical quality. Implementing cGMP protects life sciences companies and consumers by helping to reduce losses and waste, avoid recalls and fines, while assuring each batch produced meets quality standards so that they are safe and effective.
Document management systems play a key role for quality and manufacturing organizations as they apply these good manufacturing practices. One of many critical capabilities provided by OpenText™ Documentum for Quality & Manufacturing is access control and version management, so that only the latest, approved document version of sensitive and controlled documents are being accessed by authorized users.
cGMP demands constant vigilance from pharmaceutical companies and their contract manufacturers. From March 2020 to February 2022, the Food and Drug Law Institute found that deviations from written procedures within production and process controls was the second most common reason for regulatory citation in inspection-based warning letters. Pharmaceutical companies and their contract manufacturers must ensure their workers have the right printed production and process documents when and where they are needed. There’s work to be done to improve this situation in many companies.
Address the unique challenges of clean room manufacturing
It can be a challenge to efficiently control and print highly regulated documents, particularly in clean room manufacturing. If left unaddressed, these inefficiencies can introduce potential non-conformances and unexpected delays.
OpenText Documentum Quality & Manufacturing addresses these needs by providing controlled and issued print capabilities to track and distribute batch production and control records along with other controlled documents. Integration with OpenText™ Output Server adds efficiency and reduces waste with enhanced printer management and feedback controls for users to support the printing of key manufacturing documents. It provides feedback from the printer to the user and allows them to terminate prints without relying on a system administrator.
Understand how remote work complicates printing
Document Coordinators (and other authorized users) issue and track controlled documents within quality and manufacturing organizations. When the pandemic forced many into remote working environments, Document Coordinators issued documents remotely to various locations, and then coordinated with the intended recipient to be sure they are near the printer before sending the print job. This manual coordination takes time and can cause delays, waste or unauthorized access to sensitive documents.
Maintain chain of custody required by cGMP
To further enhance print management in a cGMP environment, Documentum for Quality & Manufacturing Cloud Edition (CE) 22.3 adds new secure access provided by Output Server. “Follow-me print” is a new on-demand capability that adds user authentication at the time of printing, enhancing security and convenience for the user.
The print recipient has the flexibility to retrieve print jobs when and where they choose using the printer closest to them, for example, inside the clean room at the start of their next shift. This feature ensures a clear chain of custody because the print is never left unattended at the printer. Expanded print management controls also allow users to track, reconcile and recall prints without any dependency on IT.
Learn more about the challenges of secure print controls
The Documentum for Life Sciences User Group will discuss the challenges of securing prints from unauthorized access within manufacturing environments on September 14.
You can also visit the Documentum for Life Sciences Product Forum using your OpenText My Support login credentials where you can collaborate with product team members and other users.
