Compliant Document Control
Manage & control the entire lifecycle of key regulatory documents from creation to issue
DocDomain – Terrington’s Document Control Software – provides a central point within your organisation for the circulation, reading and recording of key documents. Developed for document control within tightly regulated bioanalytical laboratories, the system has robust review procedures and audit trails. Our Document Control Software is flexible, scalable, and very easy to use via an HTML5 complaint web interface.
Are you ready for an audit from your sponsors or regulatory bodies? From creation to
issue, never lose track of your e-documents with DocDomain ….
…be audit ready
Our software complies with principles outlined by U.S. Food and Drug Administration (FDA), 21 CFR Part 11 – “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application” 21 CFR and the European Commission (EMEA). These regulations are often thought to only apply to DATA management whereas in fact they should apply to all electronic systems – including DOCUMENT management.
In brief these include the following:
- The status of every document should be traced as it passes through the system, from creation to review and approval.
- There should be a full audit trail for every document incluing the user’s name, time and date stamp for any entry into the system.
- E-Signatures (sign-offs) should comply with industry standards.
- Security/access should be configured to a users permissions on a study‑by‑study/project-by-project basis to protect data confidentiality and limit access to commercially sensitive information.
DocDomain also meets the guidelines published by the OECD (2016) concerning the application of GLP principles to computerised systems.
Tel: +44 (0)1904 567 674
Reports include – Reader Reports, showing who has read a document and when. Expiry Reports – lists all document expiry dates. Document Reports – includes the stsus of all documents in the system including Version information.
Powerful search tools allow you to search the system in an instant.
Through every stage of a document lifecycle creators, reviewers and readers are automatically notified of the document status. Whether a document is ready for review or requires reading. Combined with the document reports, you can manage doument control and status at a glance.