A Guide to Ensuring Your Data Is Secure and Available from Creation Thru the Full Mandated Retention Period

It takes time, money, and resources to generate laboratory data, so any loss of data is a direct financial loss to your regulated company, as well as a major compliance risk. Laboratory data must be secured and available to support product quality decisions, both at the time of decision making and for the full duration of the mandated retention period.

A regulated company must ensure its data is retained through the retention period and maintains its integrity during that time. While external assistance can be sought with activities such as backup and restore, disaster recovery and business continuity planning, archiving, system administration and cybersecurity, the overall responsibility for the regulated data remains with the regulated company.

Key points of discussion will be:

1. Working with Servers
2. Having a Backup and Restore Plan
3. Developing a Disaster Recovery Plan
4. Have a Business Continuity Plan
5. Archiving Data
6. Cybersecurity Considerations
7. Updates to Software

Please join us for a live discussion as we explore this topic. As always, don’t forget to bring your Empower questions for this exclusive opportunity to ask our experts anything about Empower Software.

Presenter: Neil Lander (Principal Product Manager, Waters Corporation)

Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Principal Marketing Manager focusing on Informatics solutions. He provides internal support for Empower Chromatography Data System and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives. Prior to joining Waters, he was an analytical chemist where he gained experience in both the cosmetics and specialty chemical industries.

Presenter: Fiona O'Leary (Informatics Consultant, Waters Corporation)

Fiona is an experienced Empower Software and Data Integrity professional working within the EU Professional Services Team.

She has ~18 years of experience with Waters, beginning with Technical Support & Empower Training, moving to Empower Consultancy and Workflow Optimization in more recent years. Her focus now is on building Data Integrity into the Lab workflow, Custom Field automation and Electronic Data Review / Reporting optimization.

Prior to joining Waters, Fiona spent some years in the GxP Pharmaceutical Manufacturing world, setting the scene for her current goal of helping organizations achieve their scientific and operational objectives efficiently and within compliance guidelines. She graduated from Dublin City University in 2001 with a BSc Hons. Analytical Science.