Pharma SOP Software Solutions

If you can write effective pharma SOPs, you increase your compliance success rates, but if you can't...

Standard operating procedures (SOPs) establish business objectives and practices of an organization. Well-written SOPs serve not only as the standard to measure performance and compliance against, they also serve as the forum for harmonized communication between different members of an organization. With digital SOP management solutions, you can more easily stay on top of changing pharma regulations, make changes to your SOPs, and ensure all key personnel are up to date with changes as soon as they happen.

Free Resources

Basic Procedure SOP Template (Word Document)

Frequently Asked Questions About Pharma SOPs

How Do I Write a Pharma SOP?

Familiarize yourself with current pharmaceutical regulations. Outline your internal practices based on best practices. Collaborate with your key stakeholders. Using SOP software applications, such as an integrated quality management system (QMS), you can access ready-made pharma SOP templates and customize your SOP from there.

What Is a GMP SOP?

Current good manufacturing practices (cGMPs) are outlined by regulatory bodies and standards organizations. SOPs are documents that establish your internal practices and are required to comply with regulations and standards. Aligning your pharma SOPs with cGMPs increases the probability of compliance and successful product development.

What Are the Three Types of SOP?

You may need to develop several different types of SOPs to manage your business and quality processes efficiently. Three common types of pharma SOPs include policy outlines, work instructions, and training requirements. They may be documented in the form of checklists, flowcharts, or step-by-step instructions.

What Are the 4 Steps Involved in SOP?

You can write an effective SOP by working through four phases: research and prepare, draft and revise, approve and publish. Once you identify your business objective, you can collaborate with key stakeholders to draft and ultimately approve and publish your SOP. Rely on cGMP standards and regulations to inform the details you include.

Free Pharma SOP Resources

Select all the resources you’re interested in downloading.

White Paper: Writing and Enforcing Your SOPs for GxP Compliance Success
Free Templates: Basic Procedure SOP Template (Word Document)
Industry Brief: SOP Management as a Compliance Tool in FDA and ISO Environments
Solution Overview: MasterControl Quality Excellence

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.