Compliance
We help healthcare, life sciences companies and institutions understand and navigate the complex transition from a paper-based information environment to a fully automated digital, cloud-based solution. Our best practices are based on FDA 21 CFR Part 11, HIPAA, Health Canada and EU GMP regulations.
Fully Compliant Solutions for Highly Regulated Industries
- Leveraging the Dot Compliance Suite, built into the fully scalable Salesforce Platform, we provide fully compliant solutions and consulting services to ensure healthcare and life sciences companies meet the requirement set out by the Food & Drug Administration, the EU GMP and Health Canada.
- We have experience helping small, medium and large businesses or practices go paperless in highly regulated industries, from pharmaceuticals to healthcare, medical device companies to hospitals and clinics, as well as legal marijuana producers.
- The Salesforce Platform is HIPAA and 21 CFR Part 11 compliant.
Process Catalog
Document Management
A Document Management System (DMS) is an electronic solution for drafting, reviewing, approving, tracking and storage of organizational documents.
Empower agents to quickly connect patients to the right care.
An innovative Learning Management System (LMS) is designed to offer everything from training to record management, to simplify the distribution of courses to employees/students, all done over one network.
Change Management
Change control is a formal process ensuring changes to a product or system are introduced in a controlled, synchronized and well-coordinated manner. Reducing the possibility of unnecessary changes.
Deviation & Nonconformity
Deviation and nonconformity processes are core processes in a quality system. Regulations require organizations to investigate, plan and implement actions in order to find the root cause of an event that’s deviant.
CAPA
Corrective and Preventive Actions (CAPA) improve an organization's implemented processes, eliminating causes of nonconformities or other undesirable outcomes or scenarios.
Supplier Quality Management
Supplier Quality Management is comprised of a set of procedures and processes in the organization's quality systems. Designed to increase the confidence in a supplier's ability to deliver quality goods or services.
Supplier Portal
As the reliance on Contracted Manufacturing Organizations (CMOs), critical suppliers and distribution partners grows, so too does the need to connect quality processes of the entire supply chain.
Patient Safety Tracking
Adverse event reporting and complaint handling processes are designed to ensure that report of potential failure to meet required product quality, safety standards or customer expectations are systematically captured.
Regulatory Affairs
Regulatory affairs processes in our system are designed to ensure compliance of organizations with regulations and laws, while also supporting communication with regulatory agencies and personnel. Registration of products, product variation, and registration.
Batch Production Record
Electronic Batch Record (EBR), also known as Batch Production Record (BPR), or Batch Manufacturing Record (BMR), is the methodology applied to manage and document manufacturing processes in highly regulated industries.
Device History Record
Device History Record, also is known as DHR, is the methodology employed to ensure high quality manufacturing processes in the medical device industry. The DHR process demonstrates how each specific device was manufactured.
Risk Management
The role of Dot Compliance’s Risk/Impact Assessment & Management module is to provide a detailed and systematic appraisal of the potential impacts of an amendment, alteration, or event.
Audit Management
The Dot Compliance Suite Audit Management module helps simplify and organize work and collaboration processes of compiling audits. By ensuring that internal/external audit directives.
