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At PSC Software, we often hear about issues that our customers faced with their legacy systems. We’ve gathered some of the common issues here along with solutions from ACE Docs to help resolve them.
Life sciences companies must comply with strict regulations like FDA 21 CFR Part 11, ISO 13485, and EU GMP Annex 11. These require meticulous documentation of clinical trials, manufacturing processes, and quality controls. Missing or outdated documents can lead to fines and other regulatory delays.
How ACE Docs Helps
ACE Docs ensures that all documents are version-controlled and traceable, meeting regulatory requirements. Electronic signatures are enforced, and audit trails are maintained for all records in the system.
Many life sciences organizations still rely on paper records, spreadsheets, and disconnected systems. This leads to version conflicts, data duplication, and difficulty in locating critical documents during audits.
ACE Docs centralize all quality-related documents in a single repository with optional integration available with existing systems to ensure seamless data flow. This eliminates silos and improves cross-functional visibility.
Operational documents like SOPs, lab notebooks, and trial master files (TMFs) are often stored in inconsistent formats—emails, archives, or paper folders. This disorganization leads to manual errors and slows down workflows.
ACE Docs digitizes and standardizes operational documents using templates and structured workflows, reducing manual entry and errors. Documents can be stored under their own record types and organized based on user discretion. With configurable dashboards, dynamic document statuses and real-time updates can be easily viewed.
Life sciences companies work with CROs, CMOs, regulators, and internal teams. Sharing sensitive documents securely while maintaining compliance is a major hurdle.
ACE Docs offer role-based access controls, encrypted sharing, and audit logs. An instanced portal can be provided for auditors and inspectors for additional security. As a cloud-based system, files can be accessed remotely from any part of the world, facilitating better and more secure collaboration across departments and external partners without compromising data integrity or compliance.
Regulatory inspections require complete traceability of actions, changes, and approvals. Manual systems often lack the ability to produce real-time audit trails.
ACE Docs automatically logs every document action, from edits and approvals to CAPA and training records. Real-time dashboards can be configured along with accurate reports that make audits faster and more transparent.
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 ACE Docs 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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