Pharma SOP Management Software

MasterControl offers purpose-built SOP software to help you develop, maintain, and communicate standard operating procedures. This is key to successful pharmaceutical product development and compliance.

Once you establish efficient processes, you can document them in one or more SOPs. Using a digital SOP management solution, you can automate the main phases of SOP development and adoption. These phases include research, document drafting, reviews, revisions, approvals, publishing, and training.

The process of aligning internal quality and manufacturing processes with current good manufacturing practices (cGMP) as well as business objectives can seem overwhelming but will ultimately lead to the most successful outcomes. You can access ready-made pharma SOP templates as part of an integrated quality management system (QMS) and start from there.

Streamline and automate SOP management.
Complete reviews and approvals online.
Integrate standard operating procedures with workflows.
Synchronize SOP updates with training requirements.

Pharma SOP Management Software

Most pharmaceutical companies continue to rely on paper-based processes to manage SOPs. This leads to several challenges such as:

Inefficiency

SOPs are typically created using Microsoft Word, printed out, and stored in three-ring binders. The process of routing, reviewing, and approving an SOP can be slow and inefficient. This is especially true if an organization generates hundreds or thousands of SOPs and the people who need to review and approve them are in different locations or remote. Without automated pharma SOP software, documents may even get lost while being routed, either buried in someone’s desk or computer inbox.
Poor Communication

In a fast-paced organization or an operation with facilities all over the world, SOPs are likely to change constantly, but people affected by the changes may not be notified in a timely manner. In a manual system, quality processes are not connected, making it difficult for people who operate those processes to communicate. They must initiate a phone call or send an email message and await a response. Using digital SOP management solutions, communication is initiated automatically as changes are made. All parties can be notified simultaneously. Reviews and approvals can be easily performed and recorded, even remotely.
Lack of Training

It’s bad enough that employees are not notified about new or revised SOPs in a timely manner, but it’s worse when they don’t get the appropriate training on the new SOPs. This failure to keep up with training on new SOPs is inherent in a manual system that isn’t connected to the training control process. When training requirements are directly synchronized with SOP management using SOP software, it makes it very easy to maintain adequate training cycles.
Incomplete Documentation

Effective implementation of pharma SOPs has a direct impact on product quality, which is why it’s critical for organizations to capture accurate and up-to-date information in SOPs. But it takes a lot of time and effort to manually update SOPs, so employees may sit on updates, jeopardizing conformance. It is equally difficult to rely on employees to always remember to document any changes in an SOP, including who made the change, why, and when. Leveraging templates and form controls inherent in digital solutions, you can ensure that each document is complete and accurate.
Poor Revision Control

Pharmaceutical companies that rely on a manual system often complain that it is difficult to get rid of obsolete documents. Even after SOPs have been revised and approved, old documents may resurface. In the lab, on the shop floor, or in your quality department, using uncontrolled pharma SOPs could lead not only to nonconformance, but more devastating consequences. Thankfully, you can use a robust SOP software solution to help you fulfill stringent pharmaceutical regulations and avoid these catastrophic failures.