Automation Impacting Quality Process
Quality Process Automation is not only the requirement of well-established pharma companies but also there is a huge demand and need for automation in Pharma Startups.
Digital Transformation for growing companies is the need of time as this will help the companies to battle the data integrity issues and standardize the quality process with one-time investment cost.
Few points which we can elaborate to focus on the need for growing pharma companies to automate their quality process
- A flexible EQMS system should provide an easy configuration which doesn’t require complex coding. Primarily Quality team in pharma manufacturing companies should focus on their core functional activities rather than thinking about coding and building a QMS application or implement new electronic processes, as being a Pharma startup they might not have a dedicated development team. Ease of configuration is desirable for an EQMS with drag and drop functionality.
- Drag and drop functionality will help to easily build the applications without the need to know the coding.
- Simple configuration is desirable for pharmaceutical companies because it reduces the need for dependency on application experts, and it can simplify requirements.
- Extensive system configurations which incorporate programming can complicate things makes the validation process complex.
- Document Control is needed in every phase of scale-up and growth. It is a prime requirement of the companies QMS during all stages.
- Avoid the creation of multiple copies of the same document or spreadsheet and prioritize document management with a standard template, numbering format and simple web-based editor with secure login access to establish systems and create, update documents with collaboration through each stage of the document workflow.
- Pharma growing companies need a QMS/EQMS which excels at document control to provide a smooth and satisfying user experience and stabilize documentation from the beginning.
- The system should be able to scale up from the earliest requirements to FDA inspections, and offer features for FDA-compliant e-signatures, audit trails, with integration across other QMS modules.
- Pharma growing companies need role-specific training at every stage of business growth to establish compliance and achieve standards.
- Quality Management System needs to adhere to regulatory requirements that suppliers “establish and maintain documented procedures” for identifying training and train all staff who can impact quality.
- Quality Management (EQMS) software should also provide reliable documentation of training performance to fulfill standards.
- In every stage, companies can get benefit from graphical representation and analytical trends with metrics across a growing organization.
Market Complaints Management
Pharmaceutical growing companies should be prepared for the future and track the marker complaints from the beginning. If the process is standardized it will help the companies even if they scale up in the future which is bound to happen in the Pharmaceutical Industry.
- As the products are bound to reach the review and approval phases with the FDA, pharma growing companies should be prepared to comply with audit requests.
- Flexible features like annual audit calendar, automated audit report creation, audit evidence capture help the companies to reduce the time and effort involved for preparation of audit a prime focus of area during a regulatory audit.
- Integrated audit management system with other QMS modules can provide the necessary systems to reduce regulatory risk. Selecting an EQMS with these capabilities can ensure that the system will scale to market.
Understanding the requirements at a granular level, and translate those requirements into applications in a visual way eases the process and decreases the time of implementation.
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