Our client stands as one of the top 5 global generic pharmaceutical companies, boasting a presence in over 20 manufacturing facilities across the United States, Europe, and Asia. Within the pharmaceutical sector, where adherence to Standard Operating Procedures (SOPs) governs all facets of operation, this client holds a prominent position. SOPs are the lifeblood of pharmaceutical companies, necessitating meticulous data management and immediate access to training-related information.
The pharmaceutical industry is subjected to rigorous regulation and frequent audits by esteemed bodies like the US Food and Drug Administration (US FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). A central focus of these regulatory agencies and client audits is personnel training on SOPs and compliance with these procedures. Any lapse in training adherence can trigger Form 483 findings, highlighting potential regulatory issues with significant repercussions for the company's financial bottom line.
Within this environment, all pharmaceutical company personnel must undergo extensive training. Junior-level employees are required to follow an average of 50-200 SOPs, while senior management may grapple with as many as 300-400 SOPs. Additionally, employees must successfully complete assessments at various stages to qualify for work on specific products.
The client faced the daunting task of managing an avalanche of training data, from allocation to data management and presentation during audits.
Inconsistent training processes, divergent data collection methods, and dissimilar data representation across multiple sites led to repetitive observations in various locations.
Excel's limitations, including the lack of are liable audit trail and vulnerability to tampering, raised concerns about data integrity. Regulatory bodies questioned the authenticity of Excel data, casting doubts on its reliability.
A substantial amount of non-productive time was dedicated to training assignments, training management, and assessments, accumulating toa significant yearly total.
Regulatory agencies demanded immediate access to comprehensive training data during audits. The use of Excel or physical documents created obstacles in promptly providing requested information.
Overseeing multiple IT applications and vendors across various locations posed significant challenges for the IT department. Additionally, maintaining system validation at diverse locations proved to bean arduous task.
To address these formidable challenges, the client adopted the DBS Training Manager, a solution built on CFR 21 Part 11 compliant architecture and classified as a GAMP Category 4 solution. The Training Manager, tailored for the pharmaceutical industry, streamlined training processes by automating assignments, reminders, follow-ups, and escalations. Key features included:
The implementation of the Training Manager resulted in over 60% time savings in the entire training process and streamlined training procedures across multiple geographies, ensuring zero non-compliance.
