An Enterprise Quality Management System is a software solution that ensures compliance with regulatory guidelines. It supports the cross-distribution of data across the value chain via a communications platform that allows collaboration between various levels of the chain. Most current eQMS platforms are web-based and model their approach on core business process management methods. Market leaders in eQMS create software that adopts a broad set of functionalities related to quality management. This includes the range of GxP, risk, compliance, and auditing functionalities. The quality, rather than standing alone and disjointed, therefore exhibits a closed-loop form that supports the inter-operation of the various other biotech, pharmaceutical or healthcare applications used by the company. Various applications required by the process are integrated within the system, sharing data that improves the efficiency of the workflow. The platform itself is often interoperable with other applications such as ERP and SCM.
eQMS provides users and regulatory bodies with the assurance that the enterprise’s operation is reliable, that it maintains a high level of integrity at the functional and structural levels, and that standards of completeness, attribution, disambiguation, etc. can be met. For all companies, but especially those that outsource aspects of their business or otherwise maintain a decentralized location, eQMS is indispensable to content alignment— keeping all files, information, and correspondence in sync—and to risk management—recognizing, controlling, and minimizing the risks involved with decentralization. eQMS also audits and improves resource management and internal communication. Whether processing data, controlling its dissemination, or simply storing it, quality management institutes development and testing standards that both mitigates the risks associated with hosting sensitive data and maximizes efficiency in order to maintain a competitive edge in the biotech, pharmaceutical or healthcare industries.
Why Choose an eQMS
- The main objective when choosing an eQMS is that it supports the goal of integrating quality with the company’s objectives. Rather than treat quality as a department, then, the eQMS supports the dissemination of quality related values throughout the entire process of production. This involves quality integration at global scales; rather than being locally implemented at the level of each department, general and uniform quality expectations are properly integrated into the management enterprise and applied at every operational level. This type of eQMS ensures that throughout the workflow, the input received at each stage from a previous department meets quality standards and thereby supports high-quality outputs to departments further along in the workflow.
- Good eQMS breaks down information silos and connects data across departments, enabling deeper communications and more efficient recognition of pitfalls or errors, as well as pathways toward remediating these. Applications that aid the efforts at dismantling silos include those that integrate with mobile technology and enable not just departments to communicate, but also involve patients and customers in the collaborative quality management process, keeping them as informed as other important stakeholders.
Key elements of eQMS Selection
Creating the Team
- Cross-functional teams should include quality managers at the executive, corporate, plant, and laboratory levels. Areas of quality management include:
- Manufacturing operations
- Packaging, shipping, and logistics
- Sales and finance Environmental health and safety (EHS)
- The selected group must be educated on the goals of the eQMS charter. This involves understanding the need for and underlying effects of cross-functionality within the platform.
- Research and recognize what the requirements should be for the system’s current build.
- Record what collaborations—multilevel and multiregional—will require that the software be able to perform.
- Form a central data pool from which information can be drawn, collated, and disseminated.
Selecting the vendor
- Compile your list of vendors and submit requests for information or proposals (RFI or RFP) that provide explicit information about your timeline and the custom pharmaceutical, biotech or healthcare services your company needs.
- Include such selection criteria as functionality, cost of software, and usability of the interface
- Consider build requirements: which technical features need to be set at mandatory or at priority level, or lower?
- Determine which platform should house the software (onsite v. net-based or cloud-based) and whether it should be browser specific or browser agnostic.
- Then analyze the proposals, comparing them with the particular requirements of your enterprise’s quality management operations as well as the general demands of biotech, pharmaceutical and/or healthcare regulatory bodies.
- Prescribe (or gauge) interoperability—the system’s ability to operate with other systems (such as CAPA) and integrate with ERP, CRM, SPC, and others.
- Security considerations are also important, especially in the biotech, pharmaceutical or healthcare industries. Ensure that your vendor provides security levels appropriate to the needs of your enterprise, or which you can suitably augment to fulfill your needs.
Evaluating the system
Vendor demonstrations can be used to provide detailed information about the specific functions and methods of software implementation they offer. Demonstrations should also show that the evaluation tools used by the vendor are the same across the board for each topic. Once you have selected a few prospective vendors, compile a shortlist, and run a similar demonstration parade in order to determine the final eQMS provider that you will select.
Optional pilot program
A pilot program is suggested (but is optional). During this pilot, you can test the performance of the system and allow users selected for the pilot to give feedback, according to which your vendor and in-house IT specialists can adjust the system until it meets the specifications of your company as well as of government regulations.