Remote vendor assessment
FromUS$4,500 or €4,100
A written supplier assessment with findings, a suitability rating and the questions to put to the vendor.
What is included Request a quoteRemote CSV consulting for life sciences
Hands-on computer system validation (CSV) from a working consultant with more than 35 years in industry. Everything is delivered remotely, so you get senior expertise without travel costs or delays.
How it works
- Tell us about your system and your deadline.
- We agree a fixed scope and price in writing.
- We work through your documents and systems securely, with video calls where they help.
- You receive reports and documents ready for your quality system.
Every package has a fixed price and a defined scope. Anything outside the scope is agreed with you in writing before any extra work starts.
Assessments
Part 11 and Annex 11 gap assessment
FromUS$3,750 or €3,400
One system reviewed against 21 CFR Part 11 and EU Annex 11, with a gap list ranked by risk and a remediation plan.
Request a quoteData integrity assessment
FromUS$3,750 or €3,400
One computerised system assessed against the ALCOA+ principles, with findings and an action list for your CAPA process.
What is included Request a quotePre-inspection readiness review
FromUS$6,200 or €5,600
A document-based review ahead of an MHRA, FDA or PIC/S inspection, plus a mock inspection question-and-answer session by video. It prepares you; it does not guarantee how an inspection will go.
What is included Request a quoteValidation documents
Validation starter set
FromUS$6,250 or €5,600
GxP classification, risk assessment and validation plan for one system, written to your own procedures.
Request a quoteValidation document review
FromUS$2,500 or €2,250
Review and comments on up to 10 documents (user requirements, protocols, reports), with a QA sign-off recommendation.
Request a quoteTemplate customisation
FromUS$3,750 or €3,400
Our SOPs and templates adapted to your quality management system, naming and approval flow.
Request a quoteTraining
Live online team training
FromUS$2,500 or €2,250
A half-day session by video, tailored to your systems, for up to 12 people, with a record of attendance.
Request a quoteFor self-paced learning, see the CSV 101 course and membership.
What each package includes
- Remote vendor assessment
- Is this supplier suitable for GxP use? We review their quality system, development and testing evidence, security and support arrangements. You receive a written report with findings, a suitability rating and the questions to put to the vendor. EU GMP Annex 11 says the need for a supplier audit should be based on a risk assessment, and this package gives you that assessment on paper.
- Data integrity assessment
- One computerised system assessed against the ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring and available) and current regulator guidance. You receive findings and an action list ready to feed your corrective and preventive action (CAPA) process. A process that spans several systems is quoted separately.
- Pre-inspection readiness review
- A document-based review of your CSV, data integrity and Part 11 evidence ahead of an MHRA, FDA or PIC/S inspection, followed by a mock inspection question-and-answer session by video. You receive a ranked list of gaps. It prepares you; it does not guarantee how an inspection will go.
What remote can and cannot do
Document review, structured questionnaires and video interviews keep costs down, and the start date is agreed with you when we agree the scope. Remote review has limits. PIC/S guidance (PI 041-1) notes that desktop inspections are normally limited to an assessment of data governance systems, and that on-site assessment is normally needed to verify data. If your situation needs a site audit, you arrange a local auditor, or the audit falls outside the scope of these packages.
Remote test execution needs secure access to your system, so it is not a fixed-price package. Once access terms are agreed we can quote it by the day.
Not sure where you stand?
Try the free GxP Readiness Planner. Your answers stay in your browser unless you choose to email yourself a copy.