Audits, Assessments and Due Diligence
QHSE/ GMP audits/ Other Quality Assurance Audits
Team “UnseenDots” understands various types of audit requirements applicable to pharmaceutical, chemical, FMCG and other related process industries, to ensure regulatory compliance, quality assurance, and business continuity.
We offer end to end support from audit planning to audit closure on your organization’s behalf.
Our audit services include all types assurance and surveillance audits on your behalf:
- Quality audits / GMP audits applicable to pharmaceutical industry
- Vendor/Supplier assurance audits
- Factory Acceptance testing (FAT)
- For cause audits
- Quality, Health, Safety & Environment (QHSE) audits
- Business Responsibility and Sustainability Reporting (BRSR) and ESG assurance audits
We have expertise to perform audits of following types of companies:
- Your raw/packing materials manufacturers, supplier, and Traders.
- All types of external service providers / all value chain partners.
- External contract manufacturing sites / tollers / Job working sites/ Technical partners
- Distributors, Channel partners and Warehouses.
Our auditors are the subject matter experts and certified auditors in respective domains/systems. They ensure fulfilment of your organization’s applicable audit requirements.
Auditors of UnseenDots shall always perform audit as per the scope and acceptance criteria set by your organization. Hence our audit services are customised as per your organizational requirements and our auditors are committed to follows your organizational SOP’s and templates.
We have expertise to perform following types of audits driven by various requirements:
GMP / Quality audits
Of pharmaceuticals industry as per the global regulatory and Good Manufacturing Practices (GxP) requirements.
ISO 13485
Quality management system for medical devices.
Data Integrity Audits
for pharmaceutical organizations.
ISO 9001
(Quality Management systems), ISO 14001 (Environmental management system), ISO 45001 (Occupational health and safety management system), ISO 27001 (information security management system), ISO 50001 (Energy management system (EnMS) audits.
GLP audits / ISO 17025 Audits
Audit of your quality control laboratory as per GxP requirements / GLP certifications/NABL (ISO17025) requirements.
Supply Chain security audits
Due diligence and Facility assessments:
Expansion, partnering for technical collaborations, technology transfers to external manufacturing partners are important aspects of business expansion.
UnseenDots understand these requirements and offer a unique due diligence and facility assessment services through our domain expert consultants. Our assessment service shall be highly confidential and available to the authorised parties only.
Our advisors and experts bring wealth of experience and specialized knowledge across Pharma and Chemical Industries. Our SME’s will perform technical / SHE related facility assessments / Due diligence, Regulatory risks evaluation, manufacturing capability assessment of your proposed partners.
UnseenDots will bring customised approach and personalized services as per your organizations needs with adequate analysis and insight.