Working in a regulated industry can be an excellent example of the VUCA world (Volatile, Uncertain, Complex, and Ambiguous). Sometimes it is challenging to decide on which direction to go as each company or professional has different opinions on what is correct or appropriate. An excellent way to create sustainable success in your company is to implement simple solutions that meet both company needs and regulatory requirements. Benchmarking other organizations is a good way to generate ideas and find new opportunities, but the final solution needs to be adapted to your organization considering the internal culture, values, resources, and business maturity.
One of the best ways to see if your organization is performing as intended is to have an independent assessment. This is one of the main reasons we have internal audits, but it is not uncommon to see the results from external audits uncovering more critical deficiencies not identified by internal audits. Considering that audit is performed on a sampling basis, you most likely will have some divergencies on those two processes, but when the divergencies are not exceptions but the routine, you must re-evaluate your internal audit process and resources and identify opportunities to improve their capability.
There are several ways you can select to structure your Quality Organization. Most commonly is to look for the traditional functions and the hierarchical model based on the structure of your quality management system. A good way to start is to find the appropriate answers to those questions: 1- Why your company needs a quality organization? 2- What are the key deliverables expected from the quality organization? 3- How your quality organization can make a significant impact on your business results. The answers will help you focus on the right resources and capabilities.
Traditionally, qualification and validation are documented on paper, then filed in binders or folders. That means increased demand for paper, printer consumables, folders to organize these documents, space to allocate these folders, and valuable trees to make the paper, not to mention the energy and water used in paper production. Paperless validation is an electronic process of ensuring that processes, equipment, software, spreadsheet, utilities, and cleaning, including the series of tests in Life Science companies, are compliant with the regulatory bodies such as FDA, ANVISA, TGA
GO!FIVE™ is a platform for Paperless Validation based in cloud computing, with unique features that optimize time and reduce validation costs. The platform is compatible with mobile devices and can also be accessed by computer, with the most used browsers.
On the contrary of old assumptions, remote validations can provide several business advantages as an increase in the number of validations, without increasing the validation team; validations performed three times faster; reduction in the cost of projects; cloud platform, access to the projects from anywhere in the world; features that facilitate maintaining the validated status; risk-based approach, in accordance with GAMP5 guide; and paperless validation software that is compliant with government regulatory requirements.
Traditionally, the resources allocated to manage the suppliers are proportionally significantly lower than the resources to manage your internal process and use the same mindset. To manage your suppliers efficiently and successfully, you need to apply different strategies to facilitate agile communication, risk management, mutual collaboration, robust processes, and resource flexibility. And most important, the quality strategy needs to be integrated and aligned with the sourcing strategy.
By investing in your supplier base capability, using technology for agile and effective communication, and an appropriate mix of internal and external resources, your team will be more efficient and capable of responding to the growing complexity and volatility of the supply chain.
To succeed in today’s competitive environment, every organization needs to provide a valued driven product or service and meet or exceed their customer expectation with the lower possible cost. To develop a cost-effective strategy, it is very important to have the right strategy and tools to ensure your actions are sustainable and will not compromise future business capabilities.
In the last 40 years, there were several programs deployed across organizations to eliminate deviations. Some with great results, but most programs fade out after 3-5 years. One common failure is to focus on the tools before really understanding the problem they are trying to solve. Despite poor reporting in the industry, human error is still responsible for more than 70% of deviations. To reduce that number, it is really important to understand why human errors happen, how to perform an appropriate investigation and what solutions are appropriate for each type of error mode. You can help change the way your organization deal with ‘human error.’ This begins with asking questions, looking at things from another perspective, and using a different mindset.