Compliance Documentation

Compliance documentation is a critical requirement to verify the compliance status of materials, manufacturers, and is an essential part of records that can help a company prove due diligence to regulatory authorities. The compliance documents can be in the form of certificates, test reports, material disclosures or other such permissible records. Each regulation has different standards, needs, and requirements, so the documentation varies for each regulation – such as for EU REACH, EU RoHS, SCIP, California Proposition 65,Conflict Minerals, IMDS, EU MDR (Medical Device Regulations) and so on.

Compliance Document Challenges

The biggest challenge in Compliance Documentation is the task of connecting with suppliers across the globe and collecting all required compliance documentation, validating the declarations and storing the documents in a centralized system for easy reference and retrieval. ComplianceXL can solve this challenge, by providing a cloud-based compliance management platform, combined with a dedicated multi-lingual supplier engagement team that contacts suppliers to gather, validate and update compliance documents as required. Some of the examples of compliance documents sourced are Full Material Disclosures (FMD), Certificates of Compliance (CoC), Statements of Compliance (SoC) or Conflict Minerals Reporting Templates (CMRT). The compliance platform serves as a system of record to store all your compliance documents, as well as track compliance status and generate reports as needed. A typical product roll-up report will have aggregated compliance status for the product, based on an aggregation of declarations from all your suppliers.

Some of the top challenges companies face if they utilize internal resources to collect supplier compliance documents are:

  • Lack of supplier knowledge on regulations and documentation requirements.
  • No formal agreement with suppliers regarding compliance requirements and obligations
  • Time-consuming activity, becomes add-on task for someone in a different function
  • Non-validated documents received, lack of clarity on whether to accept or reject
  • Lack of knowledge about platforms and formats used in document submissions like IMDS, SCIP, FMD, CMRT
  • Difficulty engaging with Suppliers in Non-English-speaking countries and other time-zones

Our professional services for compliance documentation enable clients to overcome all these challenges, as we deliver a fully managed solution that has been designed to keep the overheads and involvement minimal for the client. Our cloud-based platform shows you the current status and progress of the compliance program, ensuring you have adequate visibility and control, as well as the ability to generate reports as and when needed.

Talk to a Compliance Documentation Specialist today! Contact Us