Audits and Approvals

Confidentiality restrictions prevent Atlantic Analytical from disclosing all but a few of the many organizations which have audited us and provided reports. The following sampling can be listed here.

FDA

In January 2001, a 483 was issued to Atlantic Analytical citing “VAI” (Voluntary Action Indicated).

The most recent audit verified that all voluntary action cited back in 2001 had been completed in a timely manner, and in June 2004, “no 483 was issued”.

We welcome pharmaceutical audits so that we can continually strengthen our position in FDA compliance testing. Please refer to the download below for a “confidential information redacted copy” of our June 2004 FDA inspection report, with some minor VAIs which have since been addressed.

Click to download associated PDF file.

ISO/IEC

International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards bodies. Founded on 23-February-1947, the organization produces world-wide industrial and commercial standards.

ISO cooperates closely with the International Electrotechnical Commission (IEC), which is responsible for standardization of electrical equipment.

ISO/IEC 17025, released in 1999, contains all the requirements that testing and calibration laboratories must meet to demonstrate that they operate quality management systems (QMS), are technically competent, and can generate technically valid results. ISO/IEC 17025 covers such matters as quality system; personnel; document control; review of requests, tenders and contracts; subcontracting of tests and calibrations; purchasing services and supplies; services to the client; control of records; internal audits; accommodation and environmental conditions; test and calibration methods and method validation; equipment; measurement traceability; sampling; handling of test and calibration items; and reporting the results. ISO/IEC 17025 accreditation is a more thorough process than ISO 9000 registration because it recognizes a laboratory’s competence to produce technically valid results as well as its QMS conformance.

Perry Johnson Inc. is one of the world’s leading training organizations and for further information or to be become ISO/IEC 17025:2005 accredited, please refer to their website at http://www.pji.com.

Since Atlantic Analytical predominantly uses ISO certified vendors to purchase from, Atlantic Analytical has gained ISO accreditation under ISO/IEC 17025:2005 on 18-March-2007.
Click to download associated PDF file.

DSCC

The Defense Supply Center of Columbus (DSCC) is a US military based organization with involvement in the semiconductor industry and one of the largest suppliers of weapons systems spare parts. The same Gas Mass Spectrometers that are being used to perform this testing can also be used in Custom Head Space testing.

Atlantic Analytical is the only laboratory who has maintained uninterrupted DSCC “Suitability” (DSCC’s term for ‘approval’), since 1988.

Click to download a copy of our most recent “Suitability” letter.