EDMS software in the pharmaceutical industry
EDMS software in the pharmaceutical industry is a computerized system that centralizes, organizes, and secures all documents. In the pharmaceutical sector, where data volumes can quickly become significant, EDMS software makes it possible to store all digital files in one place.
Thus, an EDMS solution can help digitize processes by allowing the scanning and indexing of binders and physical archives, providing advanced search tools, and offering a complete history of each document’s lifecycle. This way, any professional in an industry (aviation or transportation, for example) can retrieve up-to-date documents in a single click and consult them.
To learn more, check out our article on the applications of EDMS software to fully understand all the challenges of such a system!
Why adopt EDMS in the pharmaceutical industry?
Regulatory and operational challenges in the pharmaceutical field make the use of EDMS software almost essential. Among its key benefits, the first is simplified regulatory compliance. The pharmaceutical sector is subject to strict standards, and EDMS software helps meet these requirements by enforcing validation workflows and electronic document signatures.
Document changes are timestamped and authenticated. In addition, the implementation of automated workflows can ensure that no critical step is overlooked. By centralizing procedures and keeping updated versions, EDMS guarantees permanent access to the necessary information during internal or external audits.
Teams are thus always assured of working with the latest versions, reducing the risk of error, accelerating innovation, and facilitating the obtaining or renewal of quality certifications.
Another major benefit is complete traceability, which is particularly valuable in the pharmaceutical field. This level of traceability makes every process transparent: if needed, it is easy to show the progression of a file or produce all required attestations, since all necessary documents are readily available.
Moreover, modern EDMS software integrates advanced data protection measures, which are imperative for securing operations in this field. With configurable access rights, only authorized users can open certain documents. Additionally, with a secure authentication protocol, all connections are protected.
Finally, EDMS software saves time. Transitioning to fully digital processes eliminates wasted time searching for paper files or printing and scanning documents. Employees can access the desired document in seconds thanks to keyword searches and multi-criteria filters.
Examples of use in the pharmaceutical context
Audits and inspections
Preparing audit files is much faster. Since documents and compliance evidence are organized and traceable within the EDMS, teams can provide all required data in a single click.
Production
The monitoring of manufacturing documentation (batch instructions, production sheets, specifications) is greatly simplified with EDMS software. Any modification to a production process can be documented in the EDMS, and the impact analysis on current or future batches is immediate thanks to document/product links.
Research & Development
EDMS software allows R&D teams to manage versions of technical documents and easily share new specifications with other departments.
In short, EDMS software in the pharmaceutical industry provides complete traceability, reinforced data security, and high efficiency in document management. Want to benefit from it? Discover Aletiq, a PLM software that integrates the functionalities of an EDMS!
