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BOMcheck matches entries in your supplier list by email extension and then by company name and provides the contact details. You can edit the draft invitation email to invite missing suppliers to join - you can also attach a PDF document to the email (for example, your company purchasing policy). BOMcheck updates the 'percentage complete' status when a new supplier joins with a matching email extension and BOMcheck sends reminder emails if suppliers do not join by your required date.
Most suppliers make their RCDs available to all customers and suppliers can add customers to confidentiality settings for all FMDs and/or RCDs in one step. If the parts you need are not declared yet, you can use your Super User Account to send parts lists and request messages to your suppliers for action. You can copy the requests to sales contacts at your suppliers and monitor the 'percentage complete' status of your lists as suppliers make declarations for your requested parts. BOMcheck sends reminder emails if suppliers do not declare parts by your required date.
Upload your BOM parts lists to the Assembly Tool and roll-up supplier declarations to calculate compliance for your assemblies. BOMcheck checks the suppliers declarations every day and re-calculates compliance for the assemblies.
Title 21 CFR Part 11 of the US Code of Federal Regulations became effective on 20 August 1997 and defines criteria under which the FDA accept: "electronic records and electronic signatures as trustworthy, reliable and equivalent to paper records and handwritten signatures executed on paper"
To ensure that a supplier's electronic records stored on BOMcheck comply with Title 21 CFR Part 11 requirements, there need to be two types of controls in place:
The document below explains these two types of control in detail, and how compliance with the Supplier Member Rules ensures that a Supplier's electronic records comply with Title 21 CFR Part 11 requirements, and are equivalent to paper records with handwritten signatures executed on paper.Electronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements