The Future of Pharma’ series, Part 3 - How leading IT projects in the pharma industry requires a unique set of skills and considerations. Here are our top 3 IT project management considerations for success:
1. Understand regulatory compliance: The pharmaceutical industry is highly regulated, and IT projects must follow strict compliance requirements. Familiarisation with various regulations such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and data privacy laws (e.g. HIPAA) is a must. Ensure that project teams, vendors and suppliers, understand these regulations and that sufficient time and effort are built into plans to cover the specifics.
2. Engage stakeholders and cross-functional teams: Projects in pharma often involve various stakeholders, including business users, developers, plant operators and IT application professionals. Engage with all relevant stakeholders from the beginning to understand and document requirements, expectations, and constraints. Promote continuous collaboration to ensure alignment and effective mitigation of risks. Open and transparent communication will help to build trust and increases the chances of overall project success.
3. Prioritise data security and privacy: The pharmaceutical industry deals with sensitive employee and patient data, as well as valuable intellectual property. Protecting data and privacy is extremely important, so implement robust security measures, encryption, and data backup protocols. Ensuring compliance with data privacy regulations, such as GDPR, is also essential. Complete regular security assessments and audits to identify potential
vulnerabilities as proactivity is key to safeguarding data.
Additionally, it's crucial to establish effective change management processes, complete thorough risk assessments, and to leverage IT delivery methodologies like Waterfall or Agile. The ever-evolving technology and regulatory landscape in the pharmaceutical industry requires delivery managers and teams to stay updated on trends and best practices.