The pharmaceutical industry is evolving, and firms must adopt more sophisticated processes and products to compete. Organizations are struggling to balance regulatory requirements with innovation pressures, and a need to create high-quality solutions. A comprehensive, cloud-based Quality Management Systems (QMS) is a necessity for organizations to establish transparent, agile operations.
Even the biggest pharmaceutical companies are exchanging legacy applications for lightweight "QMS 3.0," a term created by PWC analysts to describe a "next generation framework" for a simplified, end-to-end quality structure. The latest iteration of QMS is replacing clunky SOPs with metrics to drive "compliance, quality, and operational improvements." With the changing software framework, understanding the best options in a complex vendor landscape is challenging.
QMS software needs to fit your organization's short and long-term goals and ease highly complex regulatory processes across a global workforce. However, simply asking which QMS software is "the best" may not be the right question.
How to Find the Best Pharmaceutical Quality Management System Software (for your company)
The way to frame that question is to understand which quality management software is best for your organization. There is no one-size-fits-all QMS.
How much customization does your organization need? Does your current solution offer any unique features which are critical to operations? Perhaps most importantly, how will a QMS serve your firm over the next few years?
A QMS needs to be able to scale and expand as your organization's compliance requirements and processes grow. If your organization is in the startup or scale-up phase, the "best" QMS is not the one that only offers features for document management and employee training. While you may not need FDA compliance features at the moment, you need these systems in place to scale or grow effectively.
And, if your business plan includes an exit in the near future, a scalable QMS will make your company more attractive to potential buyers.
The best QMS for you depends on business phase
Big Pharma companies need extensive customization features in their QMS and require solutions to work with well-established processes.
If you're a startup or a scale-up, your organization doesn't need to evaluate prospective quality management processes based on customization or the ability to handle a massive global catalog of products. The best software for your company isn't going to be a highly configurable product designed for Big Pharma since you aren't trying to integrate a system around existing processes.
Simplicity and the capacity to grow are essential QMS attributes for smaller pharma companies. A solution should have the sophistication to help you build highly scalable processes and evolve into a mid-sized firm. While even the world's biggest companies are opting for a "lean and agile" QMS, the right solution for achieving that goal is highly dependent on business size and stage.
It is sometimes helpful to think in terms of the number of employees as you evaluate software. The features of our QMS, for instance, are best suited to pharma companies with 5-250 employees.
6 Things Pharmaceutical Startups and Scale-ups Need in a QMS
As pharmaceutical startups and scale-ups move from the development phase to the go-to-market phase, the role of a QMS in the organization can evolve significantly. In the earliest stages, your requirements are centered around highly powerful document control. These needs can shift as you go to market and develop use cases for demonstrating compliance.
It's easier to grow with a technology-enabled culture of excellence, quality, and transparency. Your QMS should play a critical role in helping streamline the earliest stages of growth and rapidly adopting more complex processes. The right QMS can be a competitive advantage if it can grow with you.
A lean QMS system should provide easy configuration which doesn't require complex code customization. Ideally, your small quality team should not require any programming support to build out or implement new electronic processes quickly. Ease of configuration is desirable for a QMS at startups through mid-sized organizations.
Simple configuration is desirable for pharmaceutical startups because it reduces the need for reliance on application experts, and it can simplify certification requirements. Extensive system configurations which incorporate programming can complicate things when certifying bodies require process revalidation.
Document control is needed for every phase of startup or scale-up growth, and it's a core feature of the firm's QMS during early stages. Avoid multiple folders or spreadsheets, and prioritize solutions with template engines and simple web editors to establish systems of global collaboration through each stage of the document workflow.
Pharma startups need a QMS which excels at document control to provide a smooth and satisfying user experience and establish a stable baseline of documentation from the beginning. The system should scale from the earliest requirements to FDA inspections, and offer features for FDA-compliant digital signatures.
3. Integrated, Role-Specific Training
Pharma startups need integrated and role-specific training at every stage of business growth to establish a stable baseline of compliance to achieve certification. The QMS needs to adhere to ISO requirements that suppliers "establish and maintain documented procedures" for identifying training and train all staff who can impact quality.
Quality management software should also provide reliable documentation of training performance to fulfill standards. In every stage, firms can benefit from smart tools for tracking gaps in training and metrics across a growing organization.
4. Easy Issue Resolution and Trends Visualization
Pharmaceutical startups in the earliest phases don't have an active need for a QMS which tracks non-conformances or customer complaints since products are still in development. However, establishing these systems matters as products approach the market or for ISO-certified organizations distributing to non-US markets.
While your startup may not have an active need to create quality events or track trends, there’s benefit to selecting a QMS which offers systems to standard.
5. Streamlined Product Development
Most startups and scale-ups don't need product development features in the early phases. However, adopting a QMS which offers these features can reduce time-to-market by integrating production processes with quality processes.
As your organization approaches pre-production activities, product development workflows can simplify the process of gathering required documentation for regulatory review. Once a product is under the FDA, clear documentation about product design and development is a necessity to receive product approval.
6.Audit and Change Management
As products approach the review and approval phases with the FDA, pharma startups need to be prepared to comply with potential audit requests.
While pharma startups don't need closed-loop intelligence before a product hits the market, integrating audit management systems can provide the necessary systems to reduce regulatory risk. Selecting a QMS with these capabilities can ensure that your system will scale to market.
Ask for a Demo
Choosing the right QMS is a critical decision for pharmaceutical companies in the earliest phases. While your organization may only need document management and training capabilities today, your needs are likely to expand. At every stage of the pharma company lifecycle, the right QMS should act as a comprehensive system for people, processes, and technology.
Avoid signing up for self-guided tours of solutions. Selecting a QMS is a big decision which can impact your ability to achieve certifications, pass audits and applications, sell the firm, or grow to market. Getting a live demonstration is the best way to see potential technologies in action and ask questions about how a QMS can serve your organization.
Qualio Quality Management System Software is built to serve the unique needs of pharmaceutical startups with a comprehensive range of capabilities to help your organization go to market. To learn more, request a demo.