Compliance

Document, contract and content management are key compliance, finance and quality assurance activities for a life sciences company.

Sequent offers multiple solutions that are secure, scalable and flexible to fit your needs. We offer both cloud hosted and on-premises solutions with technologies such as Veeva Vault, SharePoint & Office 365 and Agiloft Contract Management. We offer pre-built solutions on these platforms that can be configured based on your requirements.

Key features of our solution are:

1. Document Authoring: Our solutions offer template based document creation, collaborative authoring, categorizing, metadata tags and search.
2. Configurable Workflows: Review, approval, archive and destruction workflows can be configured based on managerial, department or metadata based hierarchies.
3. Version Control and Change History: Documents are numbered based on minor or major change schemes. Versions can be compared to see change history, comments and timestamps.
4. Secure Sharing: Documents can be shared using secure links or online portal within or outside the organization.
5. Submission Gateway Integration: Regulatory documents can be submitted using health authority electronic submission gateways in eCTD format. The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).