Quality Management

Resolving Data Management Issues

Resolving Data Management Issues

Many of our customers ran into challenges with their legacy systems. To help, we’ve outlined some of the most common issues and how ACE Analytics can solve them.

Top 5 Issues Facing Data Management & Data Analytics

1. Data Silos and Fragmentation

Life sciences organizations generate vast amounts of data from clinical trials, manufacturing, and real-world evidence. These datasets often reside in disconnected systems, making integration and analysis difficult. This can result in impacts such as delayed insight, extra work and redundant efforts, and compliance risks for data access and tracking.

How ACE Analytics Helps
ACE Analytics centralizes quality-related data, with optional integration with outside systems such as ERP, LIMS, and CTMS systems. This establishes the platform as a single source of truth, enabling seamless data flow and reducing silos.

2. Poor Data Quality and Integrity

Inconsistent formats, missing values, and manual errors compromise the reliability of analytics. Regulatory bodies demand strict data integrity, especially for clinical and manufacturing records. A lack of data integrity can result in regulatory non-compliance, and audit observations from documentation, data, and analytics errors.

How ACE Analytics Helps
ACE Analytics enforces data integrity, along with mandatory e-signatures and full audit trails, which supports Good Documentation Practices (GDP) and ensure compliance with standards like 21 CFR Part 11. Within the ACE platform, forms and workflows can be configured to require data entry prior to review, which can reduce the occurrence of missing values and manual entry errors. 

3. Delayed Time-to-Insight

Manual tools such as paper or often require weeks to generate dashboards or reports. This lag prevents timely decision-making in fast-paced environments like clinical trials or drug launches. This can lead to delayed market opportunities and inefficient resource allocation.

How ACE Analytics Helps
ACE Analytics offer real-time reporting through customizable dashboards that appear on the homepage after login. Automated workflows make data selection easy and straightforward, enabling readable visuals for root cause analysis, CAPA tracking, and trend identification across quality events, and more. 

4. Regulatory Compliance and Data Governance

Life sciences companies must comply with standards such as GDPR, FDA, and ISO. Managing data securely while ensuring accessibility is a major requirement for compliance with these standards. Non-compliance can result in risk of fines or operational disruptions from observations made during audits. 

How ACE Analytics Helps
ACE Analytics provide role-based access, encrypted data storage, and full traceability. They support audit readiness and ensure that all data handling aligns with regulatory expectations. Additionally, using other ACE modules such as ACE Inspection make data presentations for audits readily available for inspector access. 

5. Lack of Domain-Specific Analytics Tools

Generic analytics platforms often fail to capture the nuances of life sciences workflows, such as clinical trial protocols, lab deviations, or batch records. This translates to low user adoption and inaccurate insights. 

How ACE Analytics Helps

ACE eQMS is purpose-built for life sciences, offering both pre-configured and customizable workflows for CAPA, change control, training, and audit management. By using both ACE eQMS in tandem with ACE Analytics, custom analytics tailored to regulatory and operational needs are readily available. 

These are just some of the ways you can utilize ACE Docs to help with common issues and deficiencies from legacy document management systems. Please reach out to us if you have any questions or would like to learn more about how we can help your business. Also stay on the lookout for more tips and tricks in our resource center for our other ACE modules.

 

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