Defining and Regulating the Complex World of Software as a Medical Device
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The Quality Management System (QMS) is the backbone of every life sciences organization. It is the formalized system that documents procedures, processes and responsibilities for achieving regulatory and quality policies and objectives.
A well designed, tailored and implemented QMS should enable and facilitate your organization to effectively and efficiently progress through R&D, Clinical and Commercial operations. A one-size-fits-all approach is neither practical nor preferable. Instead, the QMS should be phase-appropriate. It should be fitted and adapted to the organization’s development stage – whether you’re in early clinical, late clinical or commercial – and to your business model, for example: in-house manufacture versus virtual or contract manufacture.
The QMS is now more commonly known as the Pharmaceutical Quality System as per ICH Q10. It contains several elements and process that are designed for the assurance of product quality. The design of the PQS is important to ensure that the system is holistic and synergistic as all elements must support and compliment each other to provide a quality backbone for the manufacturing of product. If the PQS is not appropriately planned, implemented and managed, it can become too complex with an ever increasing number of documents and leading to duplication and contradiction.
PharmaLex can provide support with PQS planning, development and implementation. We can also remediate PQS that are not working properly and we can also provide support with the implementation or remediation of specific elements of the PQS such as Supplier management, Quality Risk Management, Change Management, Learning Management and deviation management to name a few. We can design and implement PQS for MIA, WDA and MAH.
We have a broad base of expertise through our wide network of consultants, all of whom are SMEs in PQS planning, design and implementation. We can support CSV of computerized systems and have hands on experience with the implementation and comparison of several computerized systems that are used within the PQS. We also have automated tools for QRM. And we can provide case studies of successful PQS support for our clients across several different sectors from small businesses to large multinationals.
Before QMS development starts, it is critically important to understand the organization in which the QMS will be implemented. This will determine how the core requirements will be developed, as well as identifying additional requirements to fit the organization’s specific needs. This structure can broadly be broken into the following components:
We will guide you through the QMS design process, usually in a virtual or in-person workshop. Our consultants will then prepare a QMS Design report that presents you with a QMS framework and work plan for the development of the QMS. Where there is QMS documentation already available our philosophy is to leverage what’s available, update it where needed and develop new documents to fill the gaps.
Whether it’s a resource, expertise or time constraint, PharmaLex is always ready and available to support your QMS development or QMS update. We can provide all development activities in full, including development / update of: the Quality Manual / Site Master File, Standard Operating Procedures (SOPs), Forms, Quality Agreements, Training Material or Work Instructions.
We work in close association with your QA team throughout the development phase and we can flex up or down as your team needs more or less support.
If your organization is at an inflection point and requires an Electronic QMS your first step should be a conversation with PharmaLex. Whether you are a looking to change a large enterprise systems or implement your first e-QMS in an SME organization we offer expert advice to ensure that your shortlisted options are the best fit for your organization.
We have experience with many systems of all calibers. We have carefully selected and partnered with the leading system providers and have an in-depth understanding of the strengths of each platform. This detailed knowledge means we are ideally placed to support the deployment, configuration, validation and use of these systems in your organization.
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