Automated Change Control System in Just a Few Weeks

A leading Global Pharmaceutical Company implemented changes to internal operations through a series of paper forms and emails. Per GxP practices and to help ensure quality standards, any change required a multistage review focused on its impact, implementation details, and effectiveness. 

The company’s change control process woefully lacked scalability. No matter how big or small, a single Change Request (CR) required every impacted business group to approve multiple implementation stages via asynchronous emails. Multiple managers directed the process by meeting with direct reports, tying up precious time for many employees. With dozens of business groups potentially involved, CRs generated tangled spiderwebs of email chains, signatures, and document versions. Trouble with accountability and responsibility arose as each group was subject to different priorities and tried to coordinate entire networks of people. 

Physical documents served as artifacts for the change process, causing problems with accessibility and traceability. CR Admins were forced to search for and collect needed documents - often “reinventing the wheel.” A single document locked in an absent employee’s desk could bring CRs to complete standstills. To make things worse, CR admins struggled to identify these bottlenecks due to a lack of reporting mechanisms. Performing audits on changes, as regulations require, necessitated weeks of dredging up archived emails and documents, as well as any team members who implemented the changes. Finally, there was little-to-no feedback loop to measure a change’s effectiveness once complete. This system ultimately proved chaotic, leading to information getting lost and change initiatives getting stuck.