How to use Audit Docs

Quality teams at pharmaceutical and life sciences companies that need to qualify and monitor their suppliers. We work across pharma, biopharma, nutraceuticals, medical devices and CROs.

Click Sign Up, enter your details and find your company. We email a six-digit code to verify your work email. Our team then reviews your account and emails you as soon as it is approved.

Type your company name and choose to add it as a new company, then fill in the segment, address and country yourself. If your company is already on Audit Docs, choosing it fills these details in for you.

We review every new account before it can see audit information, so each company's data stays with that company. You'll get an email when your account is approved.

Audit Docs doesn't use passwords. Enter your work email and we send you a six-digit code to sign in. Keep your email account secure, because it is how you access Audit Docs.

Check the Audit Library first. If a recent report already covers the supplier site, buy it and start your assessment straight away. If no report covers the site, raise a new audit request and our team plans and carries out the audit.

Each report in the Audit Library shows the date it is valid until, so you can see at a glance whether it suits your requalification schedule.

Yes. Planned audits are listed in the Audit Library. You can ask to join an upcoming audit, or request its report once the audit is complete.

Our auditors cover GMP, GDP, GLP and GCP audits and gap assessments, against standards such as EU GMP, ICH Q7 and US FDA 21 CFR 210/211. You choose the standards you need when you raise a request.

Experienced GxP auditors with credentials such as CQI-IRCA, APIC, ECA and ISO lead auditor qualifications. The lead auditor who visits the site signs the report.

Yes. Open the quote, go to Comments and Decisions and click Request Changes. We revise the quote and issue a new version. Every version is kept, so you can see what changed.

Accepting a quote applies credits from your account, and the quote shows how many before you accept. You can see your available credits under Credits on your home page.

No. After you accept a quote, you can attach a purchase order or signed quote if your process needs one, but it's optional.

Our team initiates the audit, assigns a coordinator and contacts you to confirm the dates. You can then follow the audit from Audits on your home page.

Yes. Open the audit and go to Pre-Audit Docs. Under Sponsor Documents, click Upload to share files such as your quality agreement or product specifications. The audit agenda appears there too, once we issue it.

Yes. Use Chat on the audit page to reach the Audit Docs team at any time.

Yes. The draft goes back and forth between our coordinator, the auditor and you for as many rounds as needed. When the final draft is ready, you view it and approve it. The lead auditor then signs the report.

The signed audit report, a CAPA review report for each observation, and the audit closure statement. Open the audit, go to Report Package, and view or download each file, or click Download All.

The supplier responds to each observation, and the auditor reviews every response until it is closed. If the supplier needs more time, the extension and new due date are recorded. You can follow progress from CAPAs on your home page, or from the audit itself.

No. The risk profile is prepared by Audit Docs from the audit evidence, so it stays independent. You can view it for each audit.

Your requests, quotes, comments and uploaded documents are visible only to your organization and the Audit Docs team. They are kept separate from every other sponsor.

Your content is encrypted in transit and at rest, sign-in uses one-time codes, and decisions are recorded in an audit trail. See our Information Security Policy and Privacy Policy for details.

Open Complaints from your home page and click Raise a Complaint. Choose a category and impact, link the related request, quote or audit if there is one, and describe what happened. The complaint shows the date our response is due.

Open Best Practices from your home page. Search by name or code, then read a guideline in your browser or download a copy.