1. Know your workflow processes, but be adaptable
While Competent Authorities have specific requirements around the development, manufacture, and maintenance of drug products, drug substances, and medical devices, the specific business processes to meet those requirements are not explicitly defined by the Authorities.Companies generally develop processes to comply with the requirements and still provide an efficient flow to ensure the product/device can be supplied to the market. While your business processes may have been developed specifically for your company, certain efficiencies can be gained by broadening requirements and adopting the best-practice solution provided by OpenText. By adopting a future state business workflow that aligns with the best-practice models supplied, you can take a smarter and faster approach to your implementation, allowing your implementation partner to focus on other, higher-value customizations that will benefit your business.
2. Familiarize yourself with the DIA reference model
The Quality & Manufacturing solution has been developed with the DIA reference model as its backbone. This industry-supported model outlines an organizational structure for documentation. OpenText Documentum for Life Sciences Quality & Manufacturing module leverages this model to provide an out-of-the-box solution that can manage 95 percent of your documentation. You can derive maximum value from this model by identifying artifacts that closely align with current documentation and by adopting the DIA terminology. If necessary, additional artifacts can be added in the Quality & Manufacturing solution with consideration for validation and documentation effects.
3. Define templates
Content creation is the function of your authors. Using templates for the content ensures uniformity across the solution and makes your review team more efficient, allowing them to focus on continuity of content, rather than on formatting. OpenText Documentum for Life Sciences Quality & Manufacturing module provides the ability to associate templates with each artifact name, if desired. Templates that are imported into the system must be approved before use in content creation, allowing control over the formatting and structure of content authored in the system.
4. Know your users’ roles and functions
OpenText Documentum for Life Sciences Quality & Manufacturing module provides a site-based, role-based security model to save time and effort in determining how to set up security. The combination of membership in site and role allows the business to limit access to content, as needed while permitting appropriate individuals to perform certain business functions. Roles provided by the solution include author, reviewer, approver, quality organization approver, coordinator, and administrator. By identifying the users who fit these business roles early on in implementation, you can accelerate the system set up and provide very focused communication and process training to the impacted roles.
5. Identify your system champions
Implementing OpenText Documentum for Life Sciences is a significant change, whether moving from a paper process, a previous Documentum system, other software system, or even a previous version of the solution. The best approach to building positive momentum is to identify a small group of users who will learn the system first and act as change-makers and champions of the new system. This will go a long way to support the overall user adoption. Of course, user training is paramount to system adoption and a positive impression of the system’s capabilities. Beyond that, a core group of champions for the software can initiate a wave of excitement for the new system. Change in any large organization can be challenging, but change combined with a learning curve presents two significant hurdles. By anticipating the challenges and preparing your processes and people in advance, organizations can positively promote change and work through many of the challenges presented by those learning curves.